Kornimate/medical-research-clean huggingface dataset:
identification of the most suitable questionnaire to assess the sexual function of women living in france after colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: sexual quality of life is rarely mentioned by physicians during follow-up consultations, even though it is the source of a significant deterioration in quality of life (qol). the assessment of female sexual function is based on self-administered questionnaires. four questionnaires have been translated and validated in french: fsfi, pisq-ir, pisq-12, bisf. the objective of this project is to determine which questionnaire is acceptable and adapted to a cohort of women living in france who have undergone treatment for rectal cancer

quality of life (qol) is often impaired in the aftermath of rectal cancer management due to impaired rectal function and the impact of surgery and radiation therapy on pelvic innervation and the genitourinary sphere. female sexual function is rarely mentioned by caregivers during follow-up consultations, even though it is a source of significant alteration in the quality of life. assessment of sexual function is based on self-assessment questionnaires. most of them were written in english and correspond to the anglo-saxon culture. four questionnaires were translated and validated in french: fsfi, pisq-ir, pisq-12, bisf. two are general sexual hrqol questionnaires, 2 are sexual hrqol questionnaires developed for women with genitourinary prolapse. the identification of the acceptable questionnaire adapted to women living in france will be done through a randomized double-blind study. the duration of patient participation will be 6 months, corresponding to the period of inclusion, collection of informed consent, sending of the questionnaire bundles and collection of the bundles.

Eligibility criteria:
inclusion criteria: * female * over 18 years of age * who have signed the informed consent to participate in the study * having had rectal or recto-sigmoid cancer at least one year before, whatever the stage, treated by rectal or recto-sigmoid resection with sphincter preservation * in the course of an eventual adjuvant treatment (chemotherapy or radiotherapy) * affiliated to the social security system of the health insurance, whatever the system exclusion criteria: * colon cancer * pelvic radiotherapy for a pathology other than colorectal cancer * rectal resection without restoration of continuity (hartmann or abdominal-perineal amputation) * peritoneal carcinosis * colorectal resection for benign lesion * inflammatory bowel disease (ibd) * emergency surgery
glecaprevir/pibrentasvir real-world study in china

Conditions: Chronic Hepatitis c

Summary: to evaluate the efficacy, adverse effect, short - and long-term outcomes of glecaprevir/pibrentasvir for the treatment of chronic hepatitis c (non-cirrhotic or compensatory cirrhosis)in china through a real-world study

this study is a multi-center, prospective, real-world study, aiming to investigate the use of glecaprevir/pibrentasvir in routine clinical management of chronic hepatitis c patients and evaluate its effectiveness and safety across a heterogeneous population in china.approximately 800 patients will take part in this study, 20 sites will be included which distribute in china's major cities, thus each site will enroll 40 patients.

Eligibility criteria:
inclusion criteria: * \>18 years old * meet the standard of glecaprevir/pibrentasvir treatment exclusion criteria: * patients have contraindications to glecaprevir/pibrentasvir * pregnancy or lactation * malignancy * decompensatory cirrhosis
a phase i, single-blind, randomized study of the safety and efficacy of cellularized integra® using autologous burn-derived stem cells

Conditions: Burns

Summary: burn injuries are one of the most severe skin injuries and lead to a complex wound healing response. when the skin is wounded, stem cells in the skin must respond fast to help repair the injured tissue. the damaged skin of burn patients contains cells that are still alive and have typical stem cell characteristics. because stem cells are so important for wound healing, the investigators have combined them with an existing skin substitute, integra®, to examine the potential wound healing benefits of these stem cells. this is an investigational treatment and a first in-human trial. the purpose of this study is to test the safety of using a patient's own stem cells combined with integra®, which the investigators call integra®-stem cells (integra®-sc). the investigators hypothesize that integra®-sc will result in improved wound healing, better scar quality, and decreased scar formation at one-year post-injury.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years. * total body surface area (tbsa) ≥ 5%. * full-thickness burn requiring operative procedures. * admitted ≤ 120 hours following burn. * injury location includes a contralateral area. exclusion criteria: all participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study: * patients who are moribund. * known infection with any of the following: human immunodeficiency virus (hiv), hepatitis b, hepatitis c, human t-lymphotropic virus (htlv), syphilis, or west nile virus. * injury location limited to face and/or hands. * pregnancy. * active cancer and currently undergoing treatment.

Keywords: stem cells wound healing cicatrix skin, artificial
wound healing in diabetes (why) study

Conditions: Impaired Wound Healing; Diabetes Mellitus

Summary: this observational study aims to identify risk factors and molecular mechanisms of impaired wound healing, to guide better foot care in the diabetic population.

diabetes is linked with vascular complications of the eye, kidney and foot. barbadians suffer from an unusually high prevalence of diabetic foot complications, which can cause difficult-to-heal foot ulcers and even lead to amputations of the toes or feet.studies from the cdrc have indicated alarmingly high rates of amputation and mortality due to diabetic foot in barbados. the goal of this study is to improve early detection of persons at risk of the vascular complications of diabetes through non-invasive scanning and genetic susceptibility tests. the general hypothesis to be tested in this study is that persons with diabetes (pwd) and non-healing foot ulcers are more likely to have a disturbed mechanism for wound-healing than pwd without this particular complication. if the hypothesis is proven correct, this will empower patients and physicians with the diagnostic tests to make early interventions towards avoiding the complications of diabetes.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes * barbadian national * self reported ethnicity of black/african descent * clear knowledge of ulcer history exclusion criteria: * no clinical diagnosis of diabetes * non-national of barbados * self reported ethnicity not black/african descent * unclear knowledge of ulcer history

Keywords: diabetes vascular haptoglobin tumor necrosis factor alpha traps impaired wound healing impaired wound healing in patients with diabetes mellitus
trendelenburg's slide prevention study

Conditions: Misadventure During Surgical Operation; Postoperative Complications

Summary: the purpose of this study is to compare two cushioning materials (a gel mattress and an egg-crate foam mattress) placed beneath patients undergoing gynecologic surgery to prevent patients from sliding toward the head of the bed during head-down positioning. our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (\<2 inches) on average.

patient undergoing laparoscopic gynecologic surgery are often placed in steep (30 to 45 degrees) trendelenburg's (head lower than feet) position. this helps the bowels to move towards the patient's head, making surgery in the pelvis safer. during surgery, if patients slide a great deal toward the head of the bed, nerve injury and hernia risk may be increased. several techniques are in use to prevent patients from sliding on the bed during surgery, and of these, increasing the friction between a patient's skin and the bed surface appears to be the safest technique. two materials are in use to increase this friction: a gel pad or an egg-crate foam mattress upon which the patient lies with bare skin. this study is comparing these two materials to see which material is associated with the least amount of patient slide. our hypothesis is that the two materials will be equally good at preventing slide on the table and that slide will be less than 5 cm (\<2 inches) on average.

Eligibility criteria:
inclusion criteria: * women undergoing gynecologic laparoscopic or robotic-assisted laparoscopic surgery * trendelenburg's position is planned * general anesthesia is planned exclusion criteria: * patients with intolerance of trendelenburg's position * patients whose surgery are converted to laparotomy

Keywords: slide trendelenburg's position postoperative neurologic complaints
childhood obesity - prevention of diabetes through changed eating patterns

Conditions: Childhood Obesity; Overweight and Obesity; Adolescent Obesity; Adolescent Overweight; Diabetes

Summary: the main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. in a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15e%/day) diet whereas the intervention group will consume a higher protein (25e%/day) diet. furthermore, the investigators want to investigate the effect of frequent follow-up after intervention. compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in bmi-sds) or weight maintenance in children with overweight or obesity, and improve risk factors for type 2 diabetes and quality of life.

the study will be performed in collaboration with the staff of the well-established multi-component-overnight camps (julemærkehjem) in denmark. the multi-component-overnight camps are intensive weight loss camps to which danish schoolchildren, from 7-14 years of age, are referred to for 10-weeks intervention focusing on healthy lifestyle, healthy eating, new habits and increased physical activity. the primary outcome is anthropometry (bmi-sds, fat mass, fat-free mass). secondary outcomes are blood-tests measuring metabolic, inflammatory and liver markers and questionnaires investigating quality of life, eating behavior, eating habits and disturbed eating. the children will be measured at baseline, 10-weeks and 52-weeks follow-up. furthermore, participants will be invited to follow-up investigation 3 years, 5 years, 7 years and 10 years, respectively, after the intervention.

Eligibility criteria:
inclusion criteria: * the child attends a multi-component-overnight camp in hobro or fjordmark between september 2020 and december 2021. * the child is between 7 and 14 years of age (inclusive) while attending camp. * at least one parent/guardian submit written and oral consent to participate with his/her child. * parent/legal guardian has submitted oral and written consent to participation of their child. in case of shared custody both parents must submit written and oral consent before their child can participate in the trial. exclusion criteria: * the child has a disease, diagnose or eating disorder that require treatment. * the child or parent/guardian participate in another clinical trial or plan to do so in the near future. * the parent/guardian do not understand the written informed consent. * the child or parent/guardian are unwilling to or unable to comply with the study protocol and instruction given by the study staff.

Keywords: eating behavior eating habit quality of life dietary habits eating disorders
short-term additive effect of topical ketorolac on the management of diabetic macular edema with intravitreal bevacizumab

Conditions: DME

Summary: purpose: to evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (dme) with intravitreal bevacizumab (ivb). setting: ophthalmology department of imam hossein and torfe medical centers. ophthalmic epidemiology research center of shahid beheshti university of medical sciences methods: in a randomized double-masked placebo-controlled crossover clinical trial, all eyes with dme with best-corrected visual acuity (bcva) between 20/40 and 20/400 were included. they should have had at least one intravitreal anti-vegf injection in the past 2 months. they were randomized into two groups. both groups received two ivb injections with 6-week interval. one group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. the other group received the opposite medications. best-corrected visual acuity (bcva) and central macular thickness (cmt) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. the main outcome measure was bcva changes in logmar and the second outcome was cmt changes. the interim analysis of this study is presented in this report.


Eligibility criteria:
inclusion criteria: * bcva≤20/40 and bcva 20/400 and better * history of at least 1 intra-viteral bevacizumab (ivb) in the last 2 months * requires 2 ivb in the next 12 weeks * macular thickness \>300 μm * no other eye diseases * media clarity , pupillary dilation, and subject cooperation sufficient for adequate fundus photographs exclusion criteria: * hgb a1c\> 8 * high risk pdr * macular edema due to a cause other than diabetic retinopathy * any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy) * prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months * history of macular photocoagulation during the last 6 months * intraocular surgery(except cataract surgery) * cataract extractionin less than 6 months ago * uveitis ,nvg ,exudative amd, hr pdr. * uncontrolled glaucoma * vitreomacular traction or epiretinal membrane
35rc17_8826_nephropain phase apres : interest of the equimolar oxygen nitride mixture (meopa) in the treatment of pain in patients presenting to the emergency department for suspected renal colic: a study before after

Conditions: Renal Colic

Summary: meopa (equimolar oxygen-nitrogen protoxide mix) is a gas used in emergencies for short-term painful acts. it is often very effective with an analgesic, anxiolytic and muscle relaxant action. it is often combined with other analgesic medicines. it has already been proven in emergency medicine for short-term pain and trauma. it seems that it could be used more particularly for pains of medical origin. a study has already proved its effectiveness in the treatment of migraines in emergencies. the first phase of the nephropain study began in 2016 after a favorable opinion from the regional ethics committee. nephropain phase avant was a prospective non-interventional study on the use of analgesic drugs in nephritic colic in emergencies by dr. alexandre tanneau. this study was conducted at the university hospital of rennes and included 60 patients admitted to the emergency department for suspected renal colic. it made it possible to recruit the control group of the nephropain study. its main objective was to describe the suspected population of renal colic in rennes emergencies, to determine nephropain's primary endpoint and the number of nephropain needed subjects.


Eligibility criteria:
inclusion criteria : * age greater than or equal to 18, * presenting a suspicion of renal colic, that is to say a pain at the level of a lumbar fossa radiating towards the external genital organs, of rapidly progressive, non-febrile appearance, * having given free, informed and written consent, * affiliated to the social security system. exclusion criteria : * patient in shock of all types, defined here as an acute cardio-circulatory failure with mean arterial pressure less than 65 mm hg. * oxygen saturation below 93% in ambient air, * with suspicion of pneumothorax, * having a history of emphysema and / or copd (chronic obstructive pulmonary disease), * contraindications to the administration of meopa: patients requiring ventilation in pure oxygen; intracranial hypertension (headache associated with jet vomiting); any alteration of the state of consciousness, preventing the cooperation of the patient (glasgow score less than 15); head trauma; pneumothorax; emphysema bubbles; gas embolism; diving accident; abdominal gas distension; patient who has recently received an ophthalmic gas (sf6, c3f8, c2f6) used in ocular surgery as long as a gas bubble persists inside the eye and at least for a period of 3 months; known and unsubstituted deficiency of vitamin b12 or folic acid; neurological abnormalities of recent appearance and unexplained) * contraindication to nsaids, * patient treated in the long course by analgesic stage 3, * pregnant or lactating woman, * concomitant participation in another research involving the interventional or minimal risk and minimal human person, * major persons subject to legal protection (legal safeguards, guardianship, tutorship) and persons deprived of their liberty.
an observational study of hepatitis c virus in pregnancy

Conditions: Hepatitis C

Summary: this multi-center observational study examines risk factors for hcv transmission from mother to baby.

this multi-center observational study examines risk factors for hcv transmission from mother to baby. the study will also assess risk factors associated with hepatitis c virus (hcv) infection in pregnant women. also, the study will describe the outcomes of pregnant women with hcv as well as the outcomes of their infants to 18 months of age. approximately 750 hcv antibody positive pregnant women and their infants will be followed from baseline until the infant is 18 months. a randomly selected control cohort of 500 pregnant women who are hcv antibody negative will be followed until delivery.

Eligibility criteria:
inclusion criteria: 1. singleton pregnancy 2. an hcv antibody positive screen (case) measured using two fda-approved elisa tests, the abbott architect version 3.0 system and the ortho hcv 3.0. 3. gestational age at screening no later than 23 weeks and 6 days, and gestational age at enrollment no later than 27 weeks and 6 days, based on clinical information and evaluation of the earliest ultrasound as described below. exclusion criteria: 1. planned termination of pregnancy 2. known major fetal anomalies or demise 3. intention of the patient or the managing obstetricians for the delivery to be outside a mfmu network center, unless special provisions are made to insure infant follow-up at two and 18 months of age. 4. participation in this study in a previous pregnancy. 5. unwilling or unable to commit to 18 months of follow-up for hcv positive infants
the effectiveness of phytotherapy in sars-cov2(covid-19)

Conditions: a Randomized Double-blind Study; Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); PHYTOTHERAPIE

Summary: quercetin is one of the flavonoids. quercetin as well as rutin are recognized to be among the most active of the flavonoids. it is to quercetin that several medicinal plants, including ginkgo and st. john's wort, owe part of their therapeutic effects. often combined with vitamin c in supplements, it improves absorption by the body and delays its elimination. quercetin is extracted from a variety of plant sources, including the onion peel and seeds and pods of dimorphandra mollis, a tree in the legume family native to south america. at present, there is no scientific data to demonstrate the effectiveness of herbal medicine, regardless of the plant, to prevent or treat covid-19. on the other hand, some plant-based food supplements have anti-inflammatory or immunomodulatory properties that may disrupt inflammatory defense mechanisms useful in fighting infections, and in particular against covid-19.

type of study: a randomized, double-blind study using the quercetine in the treatment of patients with sars cov2 (covid-19) quercetin is extracted from a variety of plant sources, including the onion peel and the seeds and pods of dimorphandra mollis, a legume tree native to south america. although we are far from knowing everything about quercetin, its antioxidant, anti-inflammatory, and antihistamine (antiallergic) properties have been observed in numerous in vitro and animal studies. history on quercetin in 1937, albert szent-gyorgyi received a nobel prize for discovering vitamin c and flavonoids, as well as for exploring their biochemical properties. originally, he gave the flavonoids the name "vitamin p" because of their effectiveness in reducing the permeability of blood vessels. this name was abandoned when it was realized that these substances were not really vitamins.

Eligibility criteria:
inclusion criteria: * all patients attending the emergency department for influenza-like illness. * being over 18 years old exclusion criteria: * any patient requiring admission * non-consenting patients
application-based perioperative management of the radical cystectomy patient

Conditions: Bladder Cancer

Summary: the purpose of this study is to learn whether it is feasible to use the lifescience technologies application (lst app) in patients undergoing radical cystectomy with the eventual goal to reduce complications and readmissions to the hospital after surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of recurrent non-muscle invasive bladder cancer (nmibc) or muscle-invasive bladder cancer (mibc) and are candidates for radical cystectomy * subjects must have an internet connection and be able and willing to use an applicable device. if patients do not have an applicable device, they must be willing to borrow an ipad from the study team (to be returned at the conclusion of the study). exclusion criteria: * no internet access

Keywords: surgery education radical cystectomy cystectomy muscle-invasive bladder cancer
exploring the tumor micro-environment with 68ga-fapi-46 pet/ct in breast cancer

Conditions: Breast Cancer Invasive; Node Positive Breast Cancer

Summary: this study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 gallium-fibroblast activation protein inhibitor-46 (68ga-fapi-46) with pet imaging, in woman affected by breast cancer (bc) and referred to diagnostic imaging work-up prior to primary therapy.

all patients affected by newly diagnosed, clinically n-positive bc that have already undergone a baseline 2-deoxy-2-\[fluorine-18\]fluoro-d-glucose (18f-fdg) pet/ct (t1) will be screened for eligibility. patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. patients' eligibility will be evaluated by the referent nuclear medicine physician (t2). considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual

Eligibility criteria:
inclusion criteria: * newly diagnosed, biopsy proven breast cancer; * diagnosis of invasive breast cancer; * tumor diameter more than 2 centimeters; * radiological evidence of axillary nodes involvement; * 18f-fdg pet/ct performed as baseline diagnostic procedure, during routine diagnostic work-up; * 68ga-fapi-46 pet/ct performed within 4 weeks from 18f-fdg pet/ct; * patients suitable to primary treatment (surgery or neo-adjuvant therapy); * 68ga-fapi-46 pet/ct performed within 8 weeks from primary treatment; * female patients; * age ≥18; * willing to sign informed consent form. exclusion criteria: * pregnant or nursing patients; * unable to stay flat and cannot tolerate pet scan; * sample tissue from biopsy unavailable for assessing fibroblast activation protein (fap) expression; * eastern cooperative oncology group (ecog) performance status ≥2.

Keywords: 68ga-fapi-46 pet/ct