Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of asp health's automated rose system for bronchoscopic applications

Conditions: Lung Diseases; Lung Cancer

Summary: prospective comparison of cytology slides (bronchoscopically derived fine needle aspiration samples of lymph nodes at the time of rapid intraprocedural on site evaluation) created with the asp health's specimen preparation system to slides made by existing conventional methods.

rapid on-site evaluation (rose) has dramatically improved patient care during fine needle aspiration procedures by providing adequacy feedback to the proceduralists. in the case of endobronchial ultrasound (ebus) procedures, the samples that are collected from the patients are reviewed to determine adequacy of samples to ensure diagnostic quality samples are being processed. if the amount of specimen is found to be adequate, the interventional pulmonologists make additional passes to collect more specimen sample. while the existing rose method performed by smearing the samples on the glass slide and staining the slides has dramatically improved patient outcomes, it has several challenges/drawbacks. some of the challenges of rose slide preparation include: (i) high variability in sample quality, (ii) cumbersome process in the procedure room and (iii) possibility of cross contamination between samples, (iv) slow specimen preparation and staining process which leads to extended procedure time and (v) the cost of the personnel to prepare slides. the goal of this study is to conduct a trial of a novel automated sample preparation system from asp health that combines both the specimen deposition and staining in a compact/mobile unit. this automated system is expected to improve the workflow of the cytotechnologists and cytopathologists by ensuring reproducibility and efficiency. asp's sample preparation instrument: the instrument is an integrated device with a short processing time (measured in 2 to 3 minutes) that distributes cells from limited volume samples (measured in microliters). the process involves a novel aerosolization technique that transfers liquid sample to a glass slide via a burst of air. after the sample is deposited on the glass slide, the automated system uses an integrated heating strip to heat the specimen slide. this process is similar to using a hair dryer to dry the specimen slide in the current rose setting. after drying the slide, the system uses series of pumps to dispense microliters of stain reagent onto the slide to stain the cells. currently, the system is configured to perform diffquik staining, which is commonly used in the rose process. in the future, the staining capability will be broadened to include other staining processes such as rapid pap, h\&e staining etc. the early prototype of this instrument has been successfully tested at cleveland clinic on residual of ebus samples, serous body fluids, and bench top fnas with high diagnostic concordance.

Eligibility criteria:
inclusion criteria: * anyone who is undergoing ebus procedure for diagnosis or staging of lung diseases. exclusion criteria: -

Keywords: slide deposition slide stainer automated pahtology
continuous preperitoneal infusion of ropivacaine after open liver resection: effect on post-operative recovery and morbidity.

Conditions: Laparotomy; Hepatic Resection

Summary: intravenous morphine patient-controlled analgesia is gold standard on post - operative liver resection. but, opioids tend to be ineffective for pain that is associated with movement and have significant short-term side effects including nausea, vomiting, sedation, pruritus, constipation, urinary, retention, and respiratory depression, which are factors that often hinder a patient's recovery. prospective randomized trials has found continuous wound catheter analgesia as an accepted alternative to iv morphine pca. the researchers will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce morbidity and provide a better recovery.

this study is a prospective, double blind, randomized study. subjects will be randomized using a computer-generated table of random numbers into 2 groups. the patients scheduled to undergo open liver resection will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group a) or 0.9% saline (control group b). the patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (10-ml bolus followed by an infusion of 10 ml/h during 48 h) or the same protocol with 0.9% nacl (control group), thanks to a elastomeric pump (500ml), set to deliver a 10-ml/h connected with the catheter. in addition, all patients will receive patient-controlled intravenous morphine analgesia. the primary endpoint : the opioid-related symptom distress scale (sds) will be performed at 48 hours after surgery. secondary endpoints will be pain intensity on a visual analog scale at rest, and on coughing, morphine consumption, respiratory dysfunction, transit recovery and side effects at 48 hours, 5 days after surgery.

Eligibility criteria:
inclusion criteria: * asa i-iii * scheduled for open hepatic resection * patients must be able to understand the iv morphine pca * written informed consent * free from pain in preoperative period exclusion criteria: * age \< 18 years * severe hepatic * renal impairment * pregnancy or lactation * allergy to one of the specific drugs under study

Keywords: laparotomy hepatic resection continuous wound catheter analgesia morphine post operative recovery
videomicroscopy for the prediction of bleeding in constitutional haemorrhagic diseases

Conditions: Von Willebrand Diseases; Glanzmann Thrombasthenia

Summary: in willebrand disease, there is currently no test available to identify non-invasively patients with a high risk of bleeding from angiodysplasias the study propose to use a sublingual capillary bed analysis by video-microscopy, a sensitive, reproducible and non-invasive technique, to assess whether sublingual capillary density is predictive of hemorrhagic risk for patients with von willebrand disease.


Eligibility criteria:
inclusion criteria: * adult patient with a significant form of von willebrand disease (according to the inclusion criteria of the willebrand disease french reference center), a glanzmann thrombasthenia, a moderate to severe haemophilia a or a woman carrying the hemophilia gene * social insured patient exclusion criteria: * minor patient * refusal of consent * person benefiting from a system of legal protection * pregnant patient

Keywords: constitutional haemorrhagic diseases, videomicroscopy, prediction, bleeding videomicroscopy prediction bleeding
epstein barr virus infection in patients with radiologically isolated syndrome

Conditions: Multiple Sclerosis; Radiologically Isolated Syndrome; Epstein-Barr Virus

Summary: the clinical course of rrms patients is variable. among ris-consortium international cohorts, one third of ris patients progressed to ms at 5 years and 52.2% at 10 years. biomarkers predictive of ms conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. ebv seems to be an interesting candidate regarding its involvement ms pathophysiology. it can be easily assess in blood sample in contrast to others prognostic biomarkers validated in ris : oligoclonal bands and nfl levels in cerebrospinal fluid and serum. in ris, treatment targeting ebv could significantly modify the course of the disease. the investigators aim to make the fisrt description of the ebv epidemiology (immunoglobulin (ig)m and igg anti-viral capsid antigen (vca), igg anti epstein-barr nuclear antigen (ebna)) among ris patients and to investigate a correlation between the different antibodies' titers (igm vca, igg vca, igg ebna) and the course of the disease (clinical conversion or evidence of disease activity (eda)).


Eligibility criteria:
inclusion criteria: patients with ris confirmed by the ris expert center of the nice chu; ebna status at ris diagnosis available exclusion criteria: none
scalpel vs diathermy in repeat cesarean delivery

Conditions: Complications; Cesarean Section

Summary: the objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in pregnant patients undergoing repeat elective cesarean delivery.

it is hypothesized that wall incisions made by diathermy compared to scalpel during repeat cesarean delivery will have less incision time, as well as less blood loss. a second hypothesis is that the use of diathermy, compared with scalpel will not increase in post-operative pain. 1. this is a randomized prospective study in women undergoing elective repeat cesarean delivery at medical center hospital in odessa texas. 2. women undergoing cesarean delivery will be randomized into two groups: one group will undergo diathermy to incise the entire abdominal wall ,which includes skin, subcutaneous tissue, rectus muscle until the peritoneal cavity is visible. on the other group scalpel will be used to achieve the same aim. 3. a standardized abdominal wall incision will be made with either diathermy in cut mode or scalpel. diathermy will be set in a cut mode with standard setting as per surgeons preference. all patients in the study will get standard skin incision in terms of length and depth which will be marked by a ruler. 4. incision time ( measured in minutes and seconds with stop watch) and amount of bleeding will be measured. blood loss will be calculated by weighing (in grams) the "used" lap sponges and comparing this to the weight (in grams0 of "fresh" lap sponges. 5. post-operative pain will be measured by a visual analogue scale (vas). measurements will be taken at 6:00 to 7:00 am from post -op day 1 until hospital discharge.

Eligibility criteria:
inclusion criteria: * multiparous pregnant women 18 - 45 years. * gestational ages 37 weeks to 41 weeks, * undergoing repeat elective or repeat emergency cesarean deliveries. exclusion criteria: * informed consent can't be obtained in a manner that allows for no impression of undue influence/pressure or sufficient time for patient to consider participation. * primary cesarean deliveries - as these can bias the selection. * skin conditions such as infections, psoriasis, and eczema.
optimal timing of cord clamping in preterm pregnancy following vaginal or cesarean delivery

Conditions: Preterm Birth

Summary: this is an experimental research study for pregnant women between 23 and 37 weeks age of gestation who will be having a baby sooner than term. this study is to learn if waiting 20, 40, or 60 seconds to clamp the umbilical cord after baby delivers will improve his/her outcome and overall health. benefit to the baby may come by increasing the amount of blood in the baby's body, reducing the need for possible transfusion later, and possible prevention of other complications caused by too little blood in the baby. possible reduction of cerebral palsy may be realized by a longer interval for cord clamping.

intention is to enroll every preterm delivery into this trial containing six groups of patients, vaginal or cesarean delivery with clamping of the cord at 20, 40 or 60 seconds. expectation is 1500 deliveries over 2 year period of time. randomization upon entry to l\&d unit. removal from study if resuscitation deemed urgent by newborn staff. strong effort to keep newborn warm using appropriate measures. evaluation to determine if there are differences in transfusion, anemia, time to onset of spontaneous respiration, occurence of ivh or cp.

Eligibility criteria:
inclusion criteria: 18 years old singleton gestation between 23-37 weeks gestation able to understand and sign informed consent exclusion criteria: multiple gestation/ known intrauterine fetal death unable to sign consent

Keywords: timing of umbilical cord clamping cord clamp 20 seconds cord clamp 40 seconds cord clamp 60 seconds
a clinical trial looking at the comparability of 2 different forms of semaglutide

Conditions: Healthy Volunteers (Diabetes Mellitus, Type 2)

Summary: in this trial, two approved solutions of the medicine semaglutide will be compared in healthy volunteers. the purpose of this trial is to see if semaglutide b and semaglutide d solutions are comparable with regards to moving into, through and out of the body when given in two separate injections. participants will receive semaglutide b and semaglutide d in different periods of the trial (period 1 and period 2). participants will receive 1 subcutaneous injection of semaglutide b (0.5 mg) and 1 subcutaneous injection of semaglutide d (0.5 mg). the trial will last for 87 to 120 days (about 3 to 4 months), depending on how long the screening period (2 to 28 days) and washout period (14 to 21 days) are. participants will have a screening visit, followed by an in house stay (5 nights/6 days) and 9 visits for each period. participants will have to fast for at least 6 hours overnight with only water allowed before receiving the trial medicine on the second day of in house stay (day 1) in period 1 and period 2.


Eligibility criteria:
inclusion criteria: * male or female * aged 20-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 25.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method * any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol and acetylsalicylic acid, within 14 days prior to the day of screening * abuse or intake of alcohol, defined as any of the below: * known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (ml) of beer or lager, 100 ml of wine, or 25 ml spirits). * positive alcohol test at screening. * abuse or intake of drugs, defined as any of the below: * known or suspected drug or chemical substance abuse within 1 year before screening * positive drug of abuse test at screening
the effect of levcromakalim infusion on the cranial arteries over several hours using a high resolution mra technique in a randomized, double-blind placebo-controlled design in healthy volunteers.

Conditions: Dilatation of Cranial Arteries; MMA, STA and MCA; Headache

Summary: healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline) for 20 min. the investigator here examine the effect of levcromakalim infusion on the mma and the mca circumference over several hours using a high resolution mra technique in a randomized, double-blind placebo-controlled design in healthy volunteers. the investigator hypothesized that levcromakalim induces dilatation of cranial arteries.

healthy participants vill randomly be allocated in a 2:1 order to receive 1 mg levcromakalim or placebo (isotonic saline) for 20 min. the investigator here examine the effect of levcromakalim infusion on the mma and the mca circumference over several hours using a high resolution mra technique in a randomized, double-blind placebo-controlled design in healthy volunteers. the investigator hypothesized that levcromakalim induces dilatation of cranial arteries. mr imaging will be performed on a 3.0 tesla philips achieva scanner (philips medical systems, best, the netherlands) using an eight-element phased-array receiver head coil. we will obtain repeated mra measurements covering the mma and mca before and after levcromakalim/placebo infusion

Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes. * 18-60 years. * 50-100 kg. * women of childbearing potential must use adequate contraception. exclusion criteria: * a history of serious somatic disease * migraine or any other type of headache (except episodic tension-type headache less than once a month) * daily intake of any medication except contraceptives * contraindications for mri scan.
3d high resolution anorectal manometry in children after surgery for anorectal disorders

Conditions: Children; Anorectal Disorder; Anorectal Atresia; Hirschsprung Disease

Summary: 3d high resolution anorectal manometry (3dhram) is the most precise tool to assess function and 3d topographic picture of pressures along the anal canal. until now, it has been used only in adult population to evaluate defecatory disorders. congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract. the usefulness of the 3dhram hasn't been evaluated in children after surgery for anorectal disorders such as hirschsprung's disease and anorectal malformations. it may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients. moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.


Eligibility criteria:
inclusion criteria: * age:1-18 yr * after surgery for hirschsprung's disease, * after surgery for anorectal malformations, * after total procto/colectomy * with parental agreement for the procedure exclusion criteria: * parental disagreement * children \ 18 years

Keywords: high resolution manometry children congenital anorectal disorder surgery
doxycycline in therapy of erythema migrans

Conditions: Lyme Borreliosis

Summary: the investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.

patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. also the control group of their friends or relatives without a history of lyme borreliosis will be included. the presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * presence of erythema migrans * \>15 years old * informed consent exclusion criteria: * pregnancy * lactation * multiple erythema migrans * already treated with antibiotic for this episode of lyme borreliosis * allergy to doxycycline * treatment with drugs with known interactions with doxycycline * cerebrospinal fluid pleocytosis

Keywords: lyme borreliosis erythema migrans doxycycline subjective symptoms outcome
new hemolysis parameters in sickle cell disease

Conditions: Sickle Cell Disease

Summary: the 6-minute walk (6mwt) test is used in adults and children affected by a wide range of chronic diseases to evaluate their sub-maximal exercise capacity. it reflects the global response of various physiological systems (respiratory, cardio-vascular, neurologic, metabolic and musculosquelettic) in a situation simulating a daily life activity. in children with sickle cell disease, the 6mwt is correlated with a low level of hemoglobin, a low level of fetal hemoglobin and low red cell deformability. our team previously reported that in a population of children with sickle cell disease, highly treated with hydroxyurea, the sole factor which was independently linked to the 6mwt was the presence of silence infarct. as the cardio-vascular and cerebro-vascular injury in sickle cell disease are directly correlated with hemolysis, the investigators aim to evaluate a) the clinical relevance of endothelial and inflammation parameters and new hemolysis markers and b) if the presence of silent infarct and the 6mwt are correlated with this biological markers. this cross-sectional study will include sickle cell disease patients regularly followed for more than 5 years at hôpital universitaire des enfants reine fabiola, centre hospitalier universitaire (chu)-brugmann, centre hospitalier etterbeek-ixelles, chu saint-pierre, cliniques universitaires saint-luc (bruxelles, belgium). inclusion criteria are: sickle cell disease (ss, sbeta°, sc, sbeta+), age range : 6 to 25 years, signed informed consent. exclusion criteria are: transplanted patients, inability to perform the 6mwt (severe cognitive disability, femoral osteonecrosis with functional impairment), hospitalization and/ or transfusion in the last 3 months for acute event. demographic data and clinical data will be retrospectively recorded. blood test and 6mwt will be performed in steady state. studied analysis will be: coagulation factors, free hemoglobin, pro-b type natriuretic peptide (pro-bnp), high sensitivity c reactive protein (hs-crp), intercellular adhesion molecule (icam), vascular cell adhesion molecule (vcam) and selectins. with this study, the investigators expect to validate new predictive markers for cardio-vascular or cerebrovascular injury and to identify patients at high risk to develop these complications.


Eligibility criteria:
inclusion criteria: * sickle cell disease (hbss, s beta°, s beta+, sc) * regular follow-up from more than 5 years * written informed consent exclusion criteria: * transplanted patients * hospitalisation for an acute event within 3 months * acute transfusion within 3 months * unable to performed 6-minute walk test
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell intravenous infusion for diabetes

Conditions: Diabetes

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of diabetes

studies have shown that stem cell treatment is safe and efficacious for the treatment of diabetes. patients with diabetes will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. for patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous t cell vaccine will be utilized created from the patient's own t cells obtained by apheresis.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: diabetes stem cell treatment