Kornimate/medical-research-clean huggingface dataset:
benefit of rehabilitation program in colorectal surgery

Conditions: Colorectal Cancer

Summary: rehabilitation program improves operative results following conventional open colorectal surgery. very few data are available on such program in laparoscopic colorectal surgery.

the aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications

Eligibility criteria:
inclusion criteria: * age \>= 18 years old * colorectal cancer * inform and consent form signed * patient has valid health insurance/coverage * functional capacity ≥ 4 mets (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities) * patients with laparoscopic resection for colorectal cancer including abdominoperineal resection inclusion criteria (arm : laparoscopy + rehabilitation program): * tobacco and alcohol weaning exclusion criteria: * mbi \< 18kg/m2 * severe malnutrition * metastatic colorectal cancer * buzby index \<83 * combined surgery (hepatic resection or segmental resection of small intestine) * urgent surgery * pregnancy or maternal breastfeeding * body mass index (bmi)\> 30 kg/m2 * abdominoperineal resection * subtotal colectomy * total proctocolectomy * cons to naropin xylocaine, droperidol, ketamine * patient with a history of peptic ulcer

Keywords: rehabilitation program fast track surgery laparoscopic colorectal resection colorectal cancer morbidity
association of auditory dysfunction with retinal ischemia in behcet disease

Conditions: Behcet's Disease With Multisystem Involvement

Summary: auditory dysfunction is commonly detected in behçet's disease (bd). also, vestibular abnormalities as well as cochlear function affection have been found. the inflammatory process in bd may be the cause of audiometry abnormalities in those patients. the aim of this study is to assess hearing dysfunction in behçet patients and its relation to retinal ischemia and disease activity using conventional pure-tone audiometry (cpta), tympanogram and acoustic reflex

pure tone audiometry is a behavioral test used to measure hearing sensitivity. this measure involves the peripheral and central auditory systems. pure-tone thresholds (ptts) indicate the softest sound audible to an individual at least 50% of the time. hearing sensitivity is plotted on an audiogram, which displays intensity as a function of frequency. speech audiometry employs speech signals to assess if the patient has problems hearing speech or speech in noise. speech audiometry can be used to examine the processing ability and if it is affected by disorders of the middle ear, cochlea, auditory nerve, brainstem pathway, or auditory centers of the cortex. tympanogram is a test of middle ear functioning. this objective test also allows to view the functioning of the eustachian tube, the upper auditory pathways and the reflex contraction from the middle ear muscles. impedance testing is crucial in distinguishing a conductive loss from a sensorineural hearing loss. optical coherence tomography angiography (oct-a) for imaging the microvasculature of the retina and the choroid. behcet disease current activity form for assessment of disease activity range from 0 to 12 . 12 represents the highest disease activity. it depends on the symptoms present over the last 4 weeks.

Eligibility criteria:
inclusion criteria: * all patients fulfill the international criteria of behcet disease exclusion criteria: * age more than 50 * ear infection, * ear trauma, acoustic trauma, or usage of ototoxic drugs. * also, associated systemic diseases that can affect the hearing as infectious diseases (e.g., mumps, cmv), granulomatous diseases (e.g., sarcoidosis, wegner's granulomatosis), other autoimmune diseases (e.g., rheumatoid arthritis, cogan's syndrome, polyarteritis nodosa, relapsing polychondritis), and diseases of the bone (e.g., paget's disease).
assessment of individual risk of cardiovascular events by platelet fcgammariia

Conditions: STEMI; NSTEMI

Summary: this is a prospective, observational multicenter non-interventional cohort study. the primary objective is to determine whether platelet expression of fcγriia is associated with risk of myocardial infarction (mi), stroke and death. secondary objectives include: 1) develop a score that combines clinical characteristics plus platelet expression of fcγriia to determine the risk of mi, stroke, and death; and 2) determine whether platelet expression of fcγriia is associated with risk of major bleeding. the primary endpoint is the composite of death, mi and stroke. a secondary endpoint is the incidence of clinically significant bleeding according to the bleeding academic research consortium (barc) scale type 2-5. approximately 800 male and female subjects with confirmed mi \[st-segment elevation mi (stemi) or non-st-segment elevation mi (nstemi)\] will be enrolled before hospital discharge for the index event. approximately 10 sites in the united states will participate in this study. it is anticipated that it will take approximately 12 months to enroll approximately 800 subjects. the study and subject follow-up will continue until 1) at least 80 ischemic events (mi, stroke, and death) have occurred, and 2) the last subject enrolled has completed 18 months of follow-up.


Eligibility criteria:
inclusion criteria: 1. type 1 myocardial infarction (stemi and nstemi) 2. must have ≥ 2 of the following risk factors: 1. age ≥ 65 2. multi-vessel coronary artery disease (mvd) defined as ≥2 vessels or left main with a stenosis ≥50% 3. chronic kidney disease (ckd) defined as estimated glomerular filtration rate (gfr) ˂ 60 ml/min/1.73 m2 4. diabetes mellitus (dm) 5. prior mi 3. must agree to participate in the study, to comply with all study procedures and follow-up contact 4. signed the informed consent form exclusion criteria: 1. requirement for treatment with full dose anticoagulant therapy (e.g., for atrial fibrillation) 2. participation in another trial in which the subject is known to receive or could receive anticoagulant or antiplatelet treatment as part of the trial intervention. 3. non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years
evaluation of infection in obstructing urolithiasis

Conditions: Kidney Stone; Kidney Calculi; Urinary Tract Obstruction; Infection; Sepsis

Summary: obstructing urolithiasis can be life-threatening in the setting of urinary tract infection. the purpose of this study is to identify and validate risk factors and markers for the presence of infection and development of sepsis among patients with obstructing urolithiasis.

an obstructing stone and suspected urinary tract infection is an indication for drainage of the renal collecting system. in this setting, decompression with a ureteral stent or percutaneous nephrostomy (pcn) is associated with decreased mortality and both methods have similar efficacy. at the time of initial evaluation, it is sometimes uncertain whether infection is present, resulting in difficult management decisions. it is also difficult to identify infected patients at greatest risk of developing sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. there are currently no widely adopted criteria for the accurate diagnosis of infection in the setting of an obstructing stone. abnormal vital signs, leukocytosis, and abnormal urinalysis are relied upon, but these findings are often indeterminate. most studies to date addressing this problem have retrospectively evaluated associations of single variables with infection including pyuria and bacteriuria, or performance of sepsis screening tools such as the sepsis-related organ failure assessment (sofa). more accurate diagnostic measures for infected obstructing urolithiasis and a better understanding of its natural history are needed in order to improve patient outcomes. while early recognition of patients at significant risk of developing sepsis is essential, treatment of patients who are not clinically infected with antibiotics and decompression procedures is unnecessarily morbid. therefore, the investigators aim to develop and validate diagnostic criteria to predict development of life-threatening infection in a prospective observational fashion.

Eligibility criteria:
inclusion criteria: * men and women 18 and older * acute presentation of obstructing urolithiasis diagnosed on ct exclusion criteria: * indwelling nephrostomy tubes or ureteral stents * staghorn calculi or evidence of xanthogranulomatous pyelonephritis

Keywords: kidney stone kidney calculi urinary tract obstruction infection sepsis
metabolic and nutritional characteristics of long-stayer icu patients

Conditions: Critically Ill

Summary: the intensive care (icu) patient population has increasing number of very long icu stays. long-stayers are usually defined as requiring more than 1 week of mechanical ventilation and of icu therapy: little is know about their metabolic characteristics and their relation to outcome. the study aims at describing the demographic, nutritional and metabolic aspects of their stay. analysis of 200-250 consecutive patients admitted to the icu long-stayer program.

data extracted from the computerized icu system (pdms): age, simplified acute physiology score (sapsii), weight, bmi, nutrition risk score (nrs-2002), daily energy, protein, and glucose intakes, energy balance, blood glucose (dysglycemia and glu variability) and lactate, 24hr-insulin (goal glu 6-8 mmol/l). outcome variables: length of stay (licu), muscle strength (mrc), vital status at 90 days. patients will be followed in detail until icu discharge and for vital status until day 90 after admission data will be presented as mean or median, univariate and multivariate analysis will be performed.

Eligibility criteria:
inclusion criteria: * icu length of stay \> 7 days and enrollment to the long-stayer icu program exclusion criteria: * major burns * brain injury * severe neurological condition as primary disease

Keywords: metabolism, energy,glucose, protein, energy deficit
presbyopia in breast cancer survivors

Conditions: Presbyopia

Summary: chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. presbyopia is the inability to focus the eye on close objects, by a process called accommodation. it is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. currently, there are no known treatments that can be used to prevent or delay presbyopia. as a result, the risk, in later life, of having this condition is essentially 100%. the purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. we hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

chemotherapy drugs, used in cancer treatments, may change the timing of a vision condition known as presbyopia. presbyopia is the inability to focus the eye on close objects, by a process called accommodation. it is caused by an increase in the stiffness of the lens of the eye that occurs naturally with aging. currently, there are no known treatments that can be used to prevent or delay presbyopia. as a result, the risk, in later life, of having this condition is essentially 100%. the purpose of this research is to determine whether chemotherapy drugs are delaying the age at which people develop symptoms of presbyopia. we hope to establish that presbyopia can in fact be delayed with the use of drugs, which would ultimately lead to further research in this area.

Eligibility criteria:
inclusion criteria: * ages 45-60 * ability to understand and provide written consent in english exclusion criteria: * blindness * visual defects leading to accommodative failure * severe myopia * recurrent breast cancer

Keywords: presbyopia; breast cancer survivors
eganelisib as monotherapy and in combination with cytarabine in relapsed/refractory aml

Conditions: AML, Adult; MDS

Summary: this is a phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (aml) or r/r higher-risk myelodysplastic syndromes (hr-mds). the study consists of 2 parts: * part 1: dose escalation (de) in both monotherapy and in combination. * part 2: dose optimization


Eligibility criteria:
inclusion criteria: * pathological diagnosis of either: aml according to world health organization (who) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary aml and treatment-related aml can be included); higher-risk (ipss-r intermediate, high or very high risk at time of study entry) myelodysplastic syndromes (hr-mds) according to who 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts. * eastern cooperative oncology group (ecog) performance status ≤2. * adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib. exclusion criteria: * autologous or allogeneic stem cell transplant within 6 months prior to cycle 1 day 1. * receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency). * active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \>72 hours prior to treatment * wbc count \>25 × 10\^9/l measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the wbc count). * presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to grade ≤1 or baseline, whichever is worst, as determined by nci ctcae v 5.0, except alopecia or skin pigmentation. fatigue and neuropathy must have resolved to grade ≤2.
bioavailability study of sparc001 (study 2) in healthy adult volunteers

Conditions: Healthy

Summary: the objective of the study is to determine the relative bioavailability, safety and tolerability of sparc001 and reference001 in healthy, adult, male and female subjects


Eligibility criteria:
inclusion criteria: 1. adult, male and female volunteers, 18 to 55 years of age, inclusive, at first check-in visit 2. body mass index (bmi) ≥18 to ≤30 kg/m2 and total body weight \>50 kg (110 lbs) at screening 3. all female subjects must have a negative serum pregnancy test at screening and at each check-in visit 4. medically healthy on the basis of medical history and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), as determined by the investigator at screening and each check-in visit. exclusion criteria: 1. females who are pregnant, lactating, or likely to become pregnant during the study 2. life-time history and/or recent evidence of alcohol or drug/substance abuse disorder 3. subjects who need to maintain mental alertness throughout the study 4. subjects determined by the investigator to have any medical condition that could jeopardize their health or prejudice the results
at-home covid-19 antibody test usability assessment & behavior change study

Conditions: COVID19; COVID-19; Coronavirus

Summary: radish health and proofpilot in coordination with sanesco are running this study to help establish whether the premier biotech covid-19 igg/igm rapid test cassette (whole blood/serum/plasma authorized for distribution under emergency use authorization - though not yet fda reviewed) can be conducted effectively at home to detect covid-19 antibodies among individuals who have tested positive, or suspect they have previous contracted from covid-19 and recovered. the study also aims to examine how the results of those tests change social-distancing behaviors and general anxiety over 8 weeks post-test.


Eligibility criteria:
inclusion criteria: * reside and currently in new york city * does not have a blood clotting disease * is not abnormally queasy about taking a blood sample * not on any blood thinning medications * able to consent * willingness to take a blood sample * confirmed of highly likely past infection with covid-19 over 14 days ago and fully recovered

Keywords: antibody testing remote trial
cerebral palsy hip health related quality of life

Conditions: Cerebral Palsy; Patient Undergoing Hip Surgery; Quality of Life

Summary: children with cerebral palsy are at an increased risk of having their hips move partially or completely out of joint. this can cause pain and restrict movement at the hip, making sitting in a wheelchair uncomfortable and make personal care difficult. this condition may be treated with surgery. surgeons use x-rays taken before and after the surgery to determine whether or not the surgery has been successful. however, it is also important to know whether the surgery has improved life from the child or the caregiver's point of view. the investigators will also evaluate if waiting for surgery affects the child. this information will be added to results from a physical exam and an evaluation of the child's x-rays for a more complete picture of how this surgery impacts the lives of our patients. it is predicted that that the health-related quality of life of children with cerebral palsy will improve following surgery.

hrqol will be measured using the child health index of life with disabilities (cpchild). our specific hypothesis is that health related quality of life, as measured by the cpchild will change by at least a mean of 10 points from pre- to post-surgery.

Eligibility criteria:
inclusion criteria: * ages 4-18 * undergoing surgical treatment for hip subluxation or dislocation * diagnosis of cerebral palsy or similar condition causing motor impairment * consent to participate exclusion criteria: * diagnosis of neuromuscular disorders other than cerebral palsy * younger than 4, older than 18 * reimer's migration percentage \<40%

Keywords: cerebral palsy hip surgery quality of life
an investigational study of infliximab with prednisone or methylprednisolone versus prednisone combination treatment in immune related or severe diarrhea in patients treated with yervoy and/or opdivo

Conditions: Renal Cell Carcinoma; Melanoma; Lung Cancer

Summary: the purpose of this study is to compare the effects of infliximab and oral prednisone versus methylprednisolone and oral prednisone in patients with melanoma, lung cancer, or renal cell carcinoma who have immune related grade 3-4 diarrhea for up to 3 days or persistent grade 2 diarrhea for more than 5 days after treatment with yervoy and/or opdivo


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination * subject must have nci common toxicity grade 3-4 immune-related diarrhea for up to 3 days or persistent grade 2 diarrhea for more than 5 days * subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the combination regimen exclusion criteria: * subjects who received other anti cytotoxic t-lymphocytic antigen (ctla-4) (non-ipilimumab) or other anti-programmed death-1 (pd-1) (non-nivolumab) treatment * subjects treated with systemic corticosteroid (cst) within 1 week before randomization and subjects treated with infliximab within 7 weeks before randomization * subjects with known history of tuberculosis * subjects with immunosuppressive disease that require use of systemic steroids or immunosuppressive treatment * subjects allergic to infliximab, inactive components of infliximab, murine proteins and methylprednisolone other protocol defined inclusion/exclusion criteria could apply
a patient consensus for the research in supportive care in french cancer care centers: the cypres project

Conditions: Cancer Patients

Summary: in oncology a number of supportive care therapies are proposed to patients. this study will identify the different therapies and prioritize these therapies from the patients' perspectives. this study will provide a framework for optimizing supportive care strategies and identifying those therapies that need to be validated by clinical trials.

in oncology, supportive care should be used along with curative treatment or palliative care in order to improve patients' health-related quality of life, overall survival and to better support treatment side effects as well as the disease evolution. unfortunately, they are not widely used in clinical practice. a direct assessment of the needs perceived unmet by patients could allow to assess the magnitude of expectations to better target treatments as example. a prospective assessment of the expectations and needs of the patients is thus essential. this would also allow help to highlight the convergence between supportive care proposed and used and those expected by patients. the first step to understanding how to optimize the use of resources and to improve the quality of care is to identify patient's expectations. moreover, it is now well recognized that patients should play a key role in the research and that their active participation in research can increase the relevance of the research. in this context, the cypres project aims to: 1. assess through national consensus the patients' expectations in terms of supportive care in order to help both clinicians and health care services; 2. prioritize them and to arrange resources according to priority needs identified; 3. identify supportive care for which no previous research (evidence-based medicine) has demonstrated their usefulness. a randomized clinical trial will thus be proposed; 4. involve patients in the written, conduct and analyses, as well as communications of the randomized clinical trial.

Eligibility criteria:
inclusion criteria: * patients supported for cancer * patients of eri, espaces ligue (french cancer care centers) or patient associations * patients aged at least 18 years old exclusion criteria: * not applicable

Keywords: supportive care cancer health-related quality of life consensus participative approach patient involvement delphi method
hoarding disorder treatment with virtual reality

Conditions: Hoarding Disorder; Hoarding; Clutter

Summary: this study explores whether a facilitated peer support group called buried in treasures (bit) and a virtual reality decluttering practice can help individuals with clutter challenges.

individuals with clutter challenges participate in buried in treasures workshop (bit) that has been shown to improve symptoms of hoarding disorder. the investigators hypothesize that adding virtual reality decluttering practice to the bit workshop will decrease hoarding symptoms and level of clutter over time.

Eligibility criteria:
inclusion criteria: 1. age greater than 55 2. either gender and all ethno-racial groups 3. physically healthy male or non-pregnant female. 4. hoarding disorder primary condition 5. willing and able to understand and complete consent and study procedures 6. english speaking 7. participant should have the technology to host zoom calls exclusion criteria: 1. current or past history of bipolar, psychotic or eating disorders, substance dependence, or substance abuse in the last year. 2. clinically at risk of suicide with columbia suicide severity rating scale (c-ssrs) suicidal ideation subscale of 4 or higher (i.e. suicidal intent without specific plan) 3. major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks. 4. unable or unwilling to allow study staff into home for home assessment 5. currently at high risk for eviction 6. animal hoarding or squalor

Keywords: hoarding disorder hoarding clutter