Kornimate/medical-research-clean huggingface dataset:
evolution of proteomic profiles of intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas

Conditions: Urothelial Carcinoma

Summary: immunotherapy has become an essential therapeutic weapon against many cancers. control point inhibitors (cpi, pd-1/pd-l1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. but only 20% of patients get any clinical benefit from these heavy treatments in the long term. treating metastatic patients without distinction means taking a considerable risk of toxicity and generates major costs. it is therefore urgent and important to exceed the current criteria for using immunotherapy. recent studies have shown the interest of studying intestinal microbiota as a marker of the efficacy of immunotherapy. the investigators hypothesized that the proteomic signature of the intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas who responded to immunotherapies was special, and has very different characteristics from that of patients with the same pathology who do not respond to immunotherapy.


Eligibility criteria:
inclusion criteria: for the "controls" group: * patients undergoing treatment for a locally advanced or metastatic urothelial tumor * patients who have been on immunotherapy and 2nd-line monotherapy treatment for at least 6 months for a non-operable disease * patients whose immunotherapy has been interrupted due to progression of the disease for the "cases" group: * patients being treated in the context of a temporary authorization for use delivered for atezolizumab for the management of locally advanced or metastatic urothelial carcinomas following treatment based on platinum salts and still on treatment or patients being treated with pembrolizumab in the context of a donation for compassionate reasons (and still on treatment). exclusion criteria: * patients who do not speak or read the french language. * patients in an exclusion period determined by another study. * patients under legal guardianship or curatorship. * patients for whom it is impossible to give clear information to.
palliative care in patients with covid-19: analysis of costs of hospitalization in wards and intensive care units

Conditions: COVID-19; Palliative Care

Summary: the confrontation of covid-19 foreshadowed a serious crisis of scarce health resources worldwide. to assist in this confrontation, the palliative care scientific technical core of the clinical hospital, school of medicine, sao paulo university (usp) elaborated a triage protocol for palliative care (pali-covid tool) and it was possible to categorize the patients in three groups, according to the risk of death and needs of palliative care (pc), through the clinical evaluation of the patient that also directed them to the hospitalization resource according to their need (ward x icu).

the patients grouped as with higher risk of death and pc needs (green group) by pali-covid tool were those with a profile of end-of-life, signs of clinical deterioration and risk of death on admission and thus indicated for admission to the covid-19 palliative care inpatient unit, however some were admitted to the icu. objective: to analyze the direct costs of hospitalization of covid-19 palliative care patients in palliative care inpatient unit and icu screened as green group by the covid-19 screening protocol developed in the institution. methods: observational, cross-sectional and retrospective study of the service database of patients over 18 years of age screened as the green group (pali-covid). the variables to be investigated are related to sociodemographic and clinical data, length of stay and hospitalization scenarios, time to call for pc, outcome and costs.

Eligibility criteria:
inclusion criteria: * inpatients with severe forms of covid-19 between april 08 and july 31, 2020 * positive reverse-transcriptase polymerase chain reaction (rt-pcr). * patients with terminal illness and high clinical risk of death before covid-19. * those admitted to an icu or palliative care unit. exclusion criteria: * absence of hospitalization cost data in the institution's electronic records

Keywords: palliative care covid-19 cost allocation cost control organization and administration
efficacy of tranexamic acid in foot and ankle surgeries

Conditions: Foot and Ankle Surgeries; Bunion

Summary: epidemiology of foot and ankle surgeries that present to the hospitals in the us are often underestimated. however there has been growing emphasis on identification of these injuries and practice patterns.

approximately 20% of all foot and ankle fractures are open. excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. increase blood loss can increase the risk of infection, hematoma formation and wound complications. presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses. tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. there are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. hence there is a growing interest in achieving the same operative goals without the use of tourniquet. antifibrinolytics come to one's rescue to achieve a blood sparing effect. its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. it has been effectively used as iv, oral, topical as well as intra articular dosing. the effects of iv administration lasts 8-17 hours after the initial dose. orthopedic surgeons have incorporated txa into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. reduced bleeding translates to decreased incidence of wound hematoma and other complications. effectiveness of tranexamic acid(txa) is unknown in foot and ankle surgeries. the aim of this study is to not only evaluate effectiveness of intravenous txa in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiology) class i-iv * age 8-75. exclusion criteria: * asa class v * morbid obesity * patient refusal * patients with known coagulopathy disorder * renal insufficiency * hepatic dysfunction * serious cardiac disease * an allergy to txa or receiving antiplatelet and /or anticoagulant drugs will be excluded.

Keywords: foot and ankle surgeries tranexamic acid wound healing blood loss
regional anesthesia in colon rectal surgery

Conditions: Colon Cancer

Summary: this study will compare recurrence rates in patients with colorectal cancer who will be randomly assigned to epidural anesthesia/analgesia combined with general anesthesia or to general anesthesia followed by opioid analgesia.

the study population will consist of patients who are scheduled for open laparoscopic or laparoscopic assisted surgery for colon cancer. patients will randomized into one of two groups. the intervention group will receive combined regional and general anesthesia during surgery. postoperative pain treatment will be based on regional anesthesia techniques. the control group will receive general anesthesia during surgery. postoperative pain treatment will be based primarily on opioids. after surgery, patients will be followed daily during their hospital stay. patients will be contacted by telephone every 6 months for five years. quality of life questionnaires will be administered at these follow ups.

Eligibility criteria:
inclusion criteria: * primary colon cancer without known extension beyond colon (t3, n0, m0) * scheduled for open, laparoscopic assisted and laparoscopic resection of the colon. * written informed consent, including willingness to be randomized to epidural anesthesia/analgesia or to sevoflurane general anesthesia and postoperative opioid analgesia. exclusion criteria: * previous surgery for colon cancer; * any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy); * any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine; * age \ 85 years old; * asa physical status ≥4; * other cancer not believed by the attending surgeon to be in long-term remission; * systemic disease believed by the attending surgeon or anesthesiologist to present ≥25% two-year mortality.

Keywords: anesthesia; regional cancer recurrence anesthesia; inhalational analgesia; opioid
genotyping infarct patients to adjust and normalize thienopyridine treatment

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Genetic Resistance to Clopidogrel; Compliance to Thienopyridine Treatment

Summary: the objective of giant study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (cyp2c19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on stemi patients treated by primary pci within the 24 hours following the first chest pain.

all the stemi patients treated by primary pci (with stent implantation) within the 24 hours following the first chest pain can be included in the giant study. after the pci, they'll receive dat (aspirin + clopidogrel/prasugrel). patients will then be genotyped to determine if they carry one of the cyp2c19 gene variants making them resistant or hyper responder to clopidogrel. the genetic profile of the patients will be communicated to the physician who took care of them so that he can (or not) adjust the thienopyridine treatment (increase of the clopidogrel dosage, switch to prasugrel or switch to clopidogrel). a treatment will be prescribed for 12 months as according to the european guidelines. one year after the pci, the patients will have to be available for a follow up visit. they'll be submitted to a verify now p2y12 protocol to determine whether they were compliant to their thienopyridine treatment. a clinical follow up will be also performed to evaluate the cardiovascular events.

Eligibility criteria:
inclusion criteria: * stemi patient treated within the first 24 hours with primary pci (with stent implantation) * age superior or equal to 18 years old * informed consent signed * patient volunteer to be submitted to the 1 year visit follow up and to the clinical exams during this visit * patient benefiting from french social health system exclusion criteria: * nonstemi patient with high troponin * stemi patient treated after the first 24 hours * stable / unstable angina or silent ischemia * cardiogenic shock * oral anticoagulation (vitamin k antagonists) * contraindication for pci * age inferior to 18 years old * life expectancy inferior to 1 year * participation in another clinical trial * no signed informed consent * patient not available for the 1 year visit follow up * pregnant women * known allergy to media contrast that can not be controlled by an adapted treatment * known allergy to cobalt chromium alloy * left ventricular ejection fraction lower than 30%

Keywords: percutaneous coronary intervention acute coronary syndrome dual antiplatelet therapy clopidogrel/prasugrel genotyping stent compliance
interstitial assessment of architectural heterogeneity in prostate cancer using a fine needle photoacoustic probe

Conditions: Prostate Cancer

Summary: in this project, we will integrate the photoacoustic (pa) technology into a prostate biopsy procedure through a fine needle probe. the needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (trus) probe. when inserted into the prostate, the fine needle pa probe will assess the histological information in its surrounding tissue without any tissue extraction. the needle probe has been tested in prostate tissue samples and whole human prostates ex vivo.


Eligibility criteria:
inclusion criteria: * 1) planned prostate biopsy as part of routine clinical care * 2) \> 40 and \<80 years old exclusion criteria: * 1) known history of bleeding disorders or * 2) patients taking anticoagulants, no matter doses or washout time * 3) known allergy to silicone material * 4) unable to provide informed consent * 5) either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded * 6) involved in other investigational studies.

Keywords: biopsy
mc-5a for chemotherapy induced peripheral neuropathy

Conditions: Neuropathy, Paraneoplastic

Summary: painful chemotherapy induced peripheral neuropathy (cipn) is a common complication of cancer therapy with few treatment options. cipn is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients. the purpose of this study is to determine if patients with painful cipn will have a decrease in pain scores after treatment with the mc-5a device.


Eligibility criteria:
inclusion criteria: * painful peripheral neuropathy resulting from chemotherapy * pain must be present for minimum of 6 months * must be able to read/understand english * stable analgesics regimens allowed (no change for past 7 days) exclusion criteria: * painful peripheral neuropathy that is not the result of chemotherapy * pregnant women * patients unable to wean off anti-epileptics * patients currently receiving chemotherapy known to cause peripheral neuropathy * patients with pacemakers or implanted defibrillators * patients with vena cava or aneurysm clips * patients with a history of epilepsy

Keywords: neuropathy,paraneoplastic paraneoplastic peripheral neuropathy pain hyperalgesia
supplemental oxygen - effect on occurrence of subsequent cancer after abdominal surgery (follow-up of the proxi trial)

Conditions: Laparotomy

Summary: aim: to investigate the effect of a high inspiratory oxygen fraction (fio2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up. background: a high inspiratory oxygen fraction (fio2 = 0.80) has been linked to prevention of surgical site infection, but the danish randomized clinical multicenter trial, the proxi trial, found no difference in frequency of surgical site infection. in fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients. at this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood. primary hypothesis of this follow-up study of the proxi trial: use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * laparotomy, acute or elective. in case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index \>200 or a specimen with atypical or neoplastic cells). exclusion criteria: * other surgery within 30 days (except surgery in local anaesthesia). * chemotherapy within 3 months. * inability to give informed consent. * inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).
patient satisfaction with colonoscopy in a danish setting - what are the most important factors?

Conditions: Colorectal Cancer

Summary: the study aim is to investigate factors associated with patient satisfaction during a colonoscopy.

the study aim to capture key quality indicators and patient satisfaction for 800 patients referred for a colonoscopy at aalborg university hospital. the patient population is mix of screening and non-screening colonoscopies seen at our out-patient clinic. each colonoscopy is registered using a specially designed registration form and a more detailed form relating to the colonoscopy itself. the data collected includes: the colonoscopist endoscopy experience and education, medicine use, colonoscopy duration, unadjusted caecum intubations rate, polyp detection rate, polyps removed, cancer detection rate and nurse assisted gloucester comfort score. patient level data were recorded using a questionaire with 6 questions regarding satisfaction, pain, discomfort etc on a 10 cm analog scale.

Eligibility criteria:
inclusion criteria: * all patients referred to colonoscopy at the out-patient clinic at aalborg university department. exclusion criteria: * rejection to fill out questionaire. * patents referred to ava (advanced endoscopy unit) were excluded as the are not comparable to regular colonoscopies. most patients are referred to ava for specific endoscopy treatments such as large polyp removals etc.

Keywords: quality assurance caecum intubation rate patient satisfaction
intervention trial in early age-related macular degeneration

Conditions: Age-related Macular Degeneration (AMD)

Summary: the purpose of the i-team project is to assess whether there is a change in visual function and status of the retina after a year of intervention in subjects with early signs of age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * early amd (areds category 2) * many small drusen, or * a few intermediate-sized (63-124 micrometres in diameter) drusen, or * macular pigmentary changes or * intermediate amd (areds category 3) * extensive intermediate sized (63-124 micrometres in diameter) drusen, or * at least one large (\>125 micrometers in diameter) drusen or * geographic atrophy not involving the foveal centre * men and women age ≥50 years * bmi 18-35 kg/m2 * vision ≥ 20/40 for snellen visual acuity * lutein intake of \< 2 mg/day (including supplements) * dha intake of \< 150 mg/day (including supplements) * must be able to give written informed consent * have normal hematologic parameters * normal values of plasma albumin * normal values for liver and kidney function * no use of carotenoid, fish oil, or n3 fatty acid supplements (within 1 month of study start) exclusion criteria: * ocular media opacity (severe cataract) * history of active small bowel disease or resection * atrophic gastritis * history of hyperlipidemia or screening values as follows (ldl \> 5.33mmol/l or 205mg/dl; triglycerides \> 4.52mmol/l or \>400 mg/dl) * hypertension (\>150/90 mm hg) * diabetes mellitus (if also accompanied by signs of diabetic retinopathy) * alcohol intake of \>2 drinks/day or 14 drinks/week * pancreatic disease * dementia or alzheimer's disease * anemia, and bleeding disorders * known allergy to egg or egg products * known allergy to milk or milk products * known allergy to cocoa or chocolate products * known allergy to fish or fish oils * lactose intolerance * pregnancy or lactation * diseases that interfere with fat absorption, e.g. colitis, celiac disease, crohn's disease, cystic fibrosis (as determined by screening interview) * medication or supplements that contain a significant level of carotenoids, including an amount of lutein of more than 0.25 mg per day within 1 month of the study start * medications that interfere with fat absorption, e.g. bile sequestrants (as determined by screening interview) * use of antipsychotic, anti manic, or dementia medications * smoking or use of nicotine patches or gum (within the past 6 months) * subjects having extremely high dietary intakes of carotenoids * stroke, head injury with loss of consciousness or seizures * for us and uk center: non english speaking

Keywords: amd lutein visual function early signs of amd areds-category 2
a study to evaluate the efficacy of tolterodine prolonged release compared with propiverine for the treatment of korean patients with overactive bladder as assessed by ambulatory urodynamic monitoring

Conditions: Urinary Bladder, Overactive

Summary: the purpose of this study is to compare the difference between tolterodine prolonged release (pr) and propiverine in efficacy as assessed by the aum and to show that tolterodine pr is similar to propiverine with respect to micturition chart variables and safety profile.


Eligibility criteria:
inclusion criteria: * symptoms of urinary urgency * symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart * symptoms of overactive bladder for greater than or equal to 6 months exclusion criteria: * stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test * an average volume voided of \>200 ml per micturition as verified on the micturition chart before randomization * total daily urine volume of \>3000 ml as verified on the micturition chart before randomization
fecal microbiota transplantation for the prevention of infectious complications after liver transplantation

Conditions: Fecal Microbiota Transplantation; Orthotopic Liver Transplantation; Multi-drug Resistant Bacteria

Summary: the increasing emergence and spread of mdrb represents a major public health problem, with higher mortality in patients experiencing infections. cirrhotic patients listed for olt and after olt are at high risk of mdrb colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. therefore, effective decolonization strategies in this particular setting are urgently needed. the investigators hypothesize that heterologous fmt can reduce infections rates in the pre-and post- olt setting by mdrb decolonization and restoration of a more physiological microbiome.

the study is a double-blind, single-center, randomized controlled trial and will be offered consecutively to every adult patient on the liver transplant list. enrolled patients will be randomized (1:1) and assigned to either the heterologous or autologous fecal microbiota transplantation. the intervention of the trial is heterologous fecal microbiota transplantation, which involves the administration of fecal material from a healthy donor into the intestine of the enrolled patient. fecal samples will be collected every three months and before each microbiota transplant for evaluation of fecal microbiota composition. gut permeability tests will be evaluated at enrollment and after the first fecal transplantation. moreover, clinical and microbiota assessments will be performed after liver transplantation. all other planned assessments are part of the normal course of care.

Eligibility criteria:
inclusion criteria: * adult (age≥18 years) patients listed for olt for various etiologies. * patient's consent to participate in the study exclusion criteria: * previous total colectomy * pregnancy or breastfeeding * patients on oral or intravenous antimicrobial agents * hiv positive and not well controlled on antiretroviral therapy, or cd4+ \<200/ mm3 * active sars-cov-2 infection * neutropenia \<0.5x10\^9/l * toxic megacolon * contraindications to colonoscopy * any conditions for which, according to the physician, fmt endangers the patient's health * history of hypersensitivity to macrogol contained in bowel preparations.