Kornimate/medical-research-clean huggingface dataset:
reproducibility of the array-based comparative genomic hybridization (acgh) system using whole blood samples

Conditions: Genetic Disorders

Summary: the objective of this study is to validate the performance characteristics of the genetrait cgh microarray system dx. reproducibility among sites, lots, and operators will be evaluated.


Eligibility criteria:
inclusion criteria: * must be able to donate at least 10 ml of whole blood * must be able to provide consent, or parental consent and patient assent (if applicable) * must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites * must have at least one chromosomal change that is detectable by the genetrait cgh microarray system dx as determined by karyotype and/or fluorescence in situ hybridization (fish) analysis (within any of the 73 critical regions) exclusion criteria: * unable to donate at least 10 ml of whole blood * unable to provide consent, or parental consent and patient assent (if applicable) * not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites * does not have at least one chromosomal change that is detectable by the genetrait cgh microarray system dx as determined by karyotype and/or fish analysis (within any of the 73 critical regions)

Keywords: multiple genetic conditions will be studied
30g vs 33g needle for intravitreal injections

Conditions: Age Related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Summary: we are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.

this is a prospective, randomized, interventional pilot study, which seeks to compare the patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal injections of ranibizumab or aflibercept for the treatment of wet age-related macular degeneration (amd), diabetic macular edema (dme), or macular edema associated with retinal vein occlusion (rvo). the null hypothesis is that there is no difference in patient discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.

Eligibility criteria:
inclusion criteria: * patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet amd, dme, or rvo-associated macular edema exclusion criteria: * 1) patients who do not receive betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-ml tuberculin syringes).
modification of fluid distribution in 90 minutes

Conditions: Obstructive Sleep Apnea; Fluid Retention

Summary: obstructive sleep apnea-hypopnea syndrome (osahs) is a cardiovascular risk factor due to intermittent hypoxia phenomena. several etiological factors are involved in the pathogenesis of osas. among them, the rostro-caudal displacement of fluid during dorsal decubitus has been highlighted. under the effect of gravity, an accumulation of fluid is possible in the lower limbs, redistributing itself towards the upper parts of the body during the supine position. this phenomenon of fluid shift is usually evaluated by impedancemetry after a night in the supine position. however, some authors have shown that fluid shift occurs within 90 minutes after supine. thus, in the perspective of future studies, in order to simplify the implementation of this evaluation and to reduce the time of hospitalization necessary for the subjects participating in the study, we would like to verify the correlation between the impedancemetry measurement at t 90 min and that obtained after one night of supine position. this is a single-center, prospective, open-label study at the poitiers university hospital. we will include 30 patients over 18 years of age admitted to the regional sleep pathology center for suspected nocturnal respiratory disorders to receive polysomnography and able to provide written consent.we excluded : patients younger than 18 years of age, a history of vascular surgery of the lower limbs such as varicose vein surgery, vascular bypass surgery, carcinological surgery with lymph node dissection, the presence of metallic implants in the lower limbs or spine or implantable cardiac devices, those not receiving social securitý or not receiving it through a third party, persons receiving enhanced protection, namely minors, and persons deprived of libertý by a judicial or administrative decision, persons staying in a health or social institution, and adults under legal protection.we will perform an impedance measurement at t0, t30, t90, and after overnight supine. impedance measurement is performed using electrodes delivering a low intensity current of known frequency allowing the study of the liquid volume.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients requiring polysomnography at the regional sleep pathology center for suspected nocturnal breathing disorders * patients able to give their non-opposition exclusion criteria: * the presence of metallic implants in the lower limbs or spine or implantable pacemakers because of possible interference with the impedance signals * a history of amputation of both lower limbs * persons benefiting from reinforced protection, namely minors, persons deprived of libertý by a judicial or administrative decision, persons staying in a health or social institution and adults under legal protection, persons in emergency situations.
safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of motrem (nangibotide) in patients with septic shock

Conditions: Shock, Septic

Summary: this is a randomised, double-blind, two-stage, placebo controlled study. it is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of nangibotide versus placebo in adult patients with septic shock.

this was a randomised, double-blind, two-stage, placebo-controlled study. it was composed of 2 stages with a similar treatment regimen in which 0.3, 1.0 or 3.0 mg/kg/h of nangibotide was tested versus placebo. stage 1 was performed to investigate ascending doses of nangibotide or placebo in a sequential design in cohorts of 4 patients (3:1 randomisation). after completion of a cohort (for up to 5 days of infusion), safety and available pk data were blindly reviewed by an independent data safety monitoring board (dsmb) before progressing to the next cohort. after completion of stage 1 dsmb evaluation, the study progressed to stage 2. stage 2 investigated 3 doses of nangibotide in a randomised, balanced, parallel-group design involving up to 3 doses of nangibotide and a placebo arm. only dose arms of nangibotide considered to be safe and well tolerated during stage 1 were to be administered in stage 2.

Eligibility criteria:
inclusion criteria: * provide written informed consent (proxy/legal representative) according to local regulations * age 18 to 80 years * documented or suspected infection: lung, abdominal or elderly uti (≥65 years) * organ dysfunction defined as acute change in sofa score ≥ 2 points * refractory hypotension requiring vasopressors to maintain map ≥65mm hg despite adequate volume resuscitation of at least 20 ml/kg within 6 hours * hyperlactatemia (blood lactate \>2 mmol/l or 18 mg/dl). this criterion must be met at least once for the purpose of diagnosis within the 24 hours before study drug administration exclusion criteria: - * previous episode of septic shock (vasopressor administration) within current hospital stay * underlying concurrent immunodepression (specified in appendix 2) * solid organ transplant requiring immunosuppressive therapy * known pregnancy (positive serum pregnancy test) * prolonged qt syndrome (qtc ≥ 440 ms) * shock of any other cause, e.g. hypotension related to gastrointestinal bleeding * ongoing documented or suspected endocarditis, history of prosthetic heart valves * end-stage neurological disease * end-stage cirrhosis (child pugh class c) * acute physiology and chronic health evaluation (apache) ii score ≥ 34 * end stage chronic renal disease requiring chronic dialysis * home oxygen therapy on a regular basis for \> 6 h/day * severe obesity (bmi ≥ 40) * recent cpr (within current hospital stay) * moribund patients * decision to limit full care taken before obtaining informed consent * participation in another interventional study in the 3 months prior to randomisation

Keywords: sepsis lr12 trem1 trem-1
a phase ii , placebo-controlled study to assess efficacy of 28 day oral azd9668 in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to investigate if treatment with azd9668 for 28 days is effective in treating cystic fibrosis (cf) and if so how it compares to placebo (a substance which does not have any action).


Eligibility criteria:
inclusion criteria: * male or post-menopausal or surgically sterile female patients * have a clinical diagnosis of cystic fibrosis with lung function tests greater or equal to 40% of normal * have normal renal function exclusion criteria: * lung transplant patients * significant liver disease * any other non-cf-related lung disease that may interfere with study assessments

Keywords: cystic fibrosis
endotracheal intubation among the critically ill: hemair pilot study

Conditions: Tracheal Intubation

Summary: in order to examine the current endotracheal intubation practice among critically ill patients, a prospective observational multicenter study of adult critically ill patients was conducted from july 2015 to january 2017 involving 20 icus. in this study, the primary aim was to describe, through a prospective observational multicenter study, the current intubation practice of adult critically ill patients undergoing endotracheal intubations with a focus on deriving and validating a prediction model for both immediate airway and hemodynamic complications.

aim 1: to derive and validate a prediction model for difficult airway (three or more attempts at laryngoscopy to place an endotracheal tube and/or the need for another operator among the critically ill) \[37\]. aim 2: to derive and validate a prediction model for hemodynamic compromise, i.e., post-intubation hypotension \[defined as a decrease at any point in mean arterial pressure less than 65 mmhg; systolic blood pressure less than 80 mm hg and/or a reduction in systolic blood pressure of 40% from baseline; or the initiation of, or increase in infusion dosage of, any vasopressor medication (bolus or infusion) during the 30 minute period following intubation\] \[38-39\]. aim3: to derive and validate a predication model for hypoxemia (decrease in pulse oximetry to oxygen saturation less than 88% during the procedure).

Eligibility criteria:
inclusion criteria: * patient age ≥ 18 years * surgical and medical intensive care unit adult patients * adult patients requiring endotracheal intubation during the time period of study exclusion criteria: * patient age \< 18 years * endotracheal intubations performed outside the icu (in the operating room, in and outside the hospital) are excluded

Keywords: airway management critically ill hemodynamic management intubation prospective study risk factors
high-intensity interval training versus fatmax training in diabetic type 2

Conditions: Diabetes Mellitus, Type 2

Summary: the project investigates the effects of two exercise protocols at different intensities, high-intensity interval training and constant load at fatmax, for 12 weeks in maximal fat oxidation, hormonal regulation of appetite, and insulin sensitivity in persons with obesity and type 2 diabetes mellitus. the participants will be of both sexes with ages between 40 and 55 years, belonging to the province of cádiz. sixty volunteers will be randomly allocated into three groups: high-intensity interval training (hiit), fatmax, and control groups. the assessments will be at the previous exercise intervention, posterior the exercise intervention, and 12 weeks after the last intervention. the outcome variables will include body composition, oral glucose tolerance test, appetite, plasma glucose, lipids in plasma, hormones, and adipokines.


Eligibility criteria:
inclusion criteria: * non-smoking * non-alcoholic (\ 25 kg/m maintaining the habitual dietary patterns without a body mass reduction higher than 2% during the last 6 months * not being insulin dependent * absence of injury, disease or disability or other known medical condition which could affect the ability to successfully participate in physical exercise tests * absence of cardiovascular disease (angina, peripheral or cerebro-vascular disease, etc.). * absence of neurologic and psychiatric diseases. * absence of respiratory diseases (pulmonary hypertension, chronic obstructive pulmonary disease, etc.). * absence of other metabolic diseases (hyper/hypoparathyroidism, hyper/hypothyroidism, cushing's disease, type 1 diabetes, etc.) * absence of active inflammatory bowel disease * absence of kidney disease * absence of tumors * absence of coagulation dysfunction * not under treatment with medications k known to affect glucose metabolism, recent steroid treatment (within 6 months), or hormone replacement therapy * be able to understand communication in spanish or english. exclusion criteria: * they do not attend more than 2 or 4 consecutive sessions of nutritional counseling or physical training respectively. * missing more than 4 or 6 sessions in total of nutritional counseling or physical training respectively.

Keywords: hiit fatmax maximum fat oxidation diabetes mellitus 2
myo-inositol administration in gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: myo-inositol is an insulin sensitizing agent that ameliorate the insulin resistance in women affected by gestational diabetes (gdm), but there is no information about the effect on the glucose profile. maternal hyperglycemia of gdm, especially hypoglycemic excursions, are associated with adverse pregnancy outcome. continuous glucose monitoring system (cgms) is obviously better than intermittent self monitoring in detecting glucose profile and magnitude and duration of glucose fluctuations. for this reason, we propose a clinical trial to analyze the characteristics of glucose variability in gdm women,treated with diet and folic acid alone or with diet, folic acid and myo-inositol supplementation.

our study is a randomized, prospective, controlled trial, including the first 30 consecutive caucasian gestational diabetes patients diagnosed,according the international association of diabetes and pregnancy study group (iadpsg) panel criteria, from november 2013 in the department of obstetric and gynecology of messina university (italy). after an informed consent they will be randomly assigned to receive (n. 15) diet and folic acid (400 mcg per day) alone or (n. 15) diet, folic acid (400 mcg per day) and myo-inositol (2 g. twice a day)supplementation. the insulin sensitivity index (homa-ir) and the glycemic profile will be monitor by cgms for each patient at gdm diagnosis and after 8 weeks of treatment the pregnant women who will delivery before the time treatment (8 weeks) or who need insulin will be excluded.

Eligibility criteria:
inclusion criteria: * gestational diabetes diagnosed within 28 weeks * caucasian pregnant women exclusion criteria: * non caucasian pregnant women * delivery before 8 weeks of treatment

Keywords: gestational diabetes mellitus carbohydrate intolerance myo-inositol insulin resistance
influence of pain on exercise-induced hypoalgesia

Conditions: Pain

Summary: the purpose of this study is to investigate how acute pain induced by hypertonic saline prior to exercise influence the magnitude of exercise-induced hypoalgesia after a 3 min isometric wallsquat exercise in healthy subjects. the study is a single blinded (investigator) randomized cross-over trial the results from the study may be of great importance to the understanding of exercise-induced hypoalgesia, and whether the presence of pain affects the effects of exercise.

exercise is recommended to promote and maintain health and as treatment for more than 25 chronic diseases and pain conditions. the mechanisms underlying pain relief of exercise are largely unknown but may be related to the modulation of central descending pain inhibitory pathways after acute exercise bouts. exercise-induced hypoalgesia (eih) is typically assessed as the temporary change in ppts after a short acute exercise bout and eih is seen as a proxy of descending pain inhibitory control. in general, eih seems hypoalgesic (functional) in asymptomatic subjects. a hyperalgesic (impaired) eih response has been reported in different chronic pain populations, although a functional eih response also has been reported in subgroups of knee osteoarthritis patients. this implies differences in the acute response to exercise between healthy (pain-free) subjects and chronic pain patients, but it is still unknown whether the presence of pain itself affects the pain alleviating response (i.e. the eih response) to acute exercise. it is hypothesized that acute pain will decrease the eih response magnitude following hypertonic saline injection compared with the control injection. this study will increase the insight into the eih mechanisms in healthy subjects in general, and how the presence of pain affects the body's own ability to modulate pain during exercise.

Eligibility criteria:
inclusion criteria: * pain-free * understands and writes danish exclusion criteria: * pregnancy * previous addictive behavior defined as abuse of hash, opioids or other euphoric substances. * previous painful or mental illnesses, neurological or circulatory diseases in the form of heart or lung disease. * surgery within last 3 months * pain on the days of testing * pain for more than 2 weeks within the last 3 months

Keywords: exercise-induced hypoalgesia pressure pain threshold hypertonic saline
feasibility and safety study using preoperative high-dose single-fraction image-guided radiotherapy for men undergoing radical prostatectomy at high-risk for extraprostatic cancer

Conditions: Prostate Cancer

Summary: this study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). the investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy. the investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.


Eligibility criteria:
inclusion criteria: * biopsy-proven prostate cancer verified at mskcc. the biopsy will include a minimum of 10 cores * radical prostatectomy (rp) chosen as the therapeutic method * the size of the prostate will be \< 70 cc by transrectal ultrasound or endorectal mri imaging * no radiographic evidence of lymph node metastases, bone metastases or soft tissue disease * risk of extraprostatic cancer of \> 40% based on the mskcc surgical nomogram * age \> or = to 18 years * kps \> or = to 80 * able to tolerate immobilization cradle positioning exclusion criteria: * allergic reaction to intravenous ct contrast (if premedicated, pt will not be excluded) * prior radiation to the planned target region * patients receiving concurrent chemotherapy * neoadjuvant hormonal therapy luteinizing-hormone-releasing hormone(lhrh)agonist and/or antiandrogen) * prior transurethral resection of the prostate * normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 gy dose constraints * dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies * creatinine clearance \<60 ml/min/1.73m2

Keywords: prostate radiation radical prostatectomy 09-013
effect of truetear corneal surface imaging

Conditions: Cataract; Myopia

Summary: this study will evaluate the utility of truetear™ to improve anterior corneal surface imaging quality before cataract surgery, refractive lens exchange, or laser refractive surgery.

corneal imaging will be repeated before and after truetear use during a single patient visit. image quality measures will be compared.

Eligibility criteria:
inclusion criteria: * scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery exclusion criteria: * a cardiac pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device (e.g. cochlear implant) in the head or neck * chronic or frequent nosebleeds, a bleeding disorder (e.g. hemophilia), or another condition that can lead to increased bleeding * a known hypersensitivity (allergy) to the hydrogel material that comes into contact with the inside of the nose during use of the trueteartm device * pregnancy * presence of any ocular disease or condition which in the investigator's opinion would confound the study results
an open-label, fih study evaluating the safety, tolerability, and efficacy of vctx211 combination product in subjects with t1d

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Summary: this is an open-label, multicenter, phase 1/2 study evaluating the safety, tolerability, and efficacy of vctx211 combination product in subjects with t1d

vctx211 combination product (unit) compromises 2 components: (1) allogeneic pancreatic endoderm cells (pec211) genetically modified using cluster regularly interspaced short palindromic repeats/ crispr-associated protein 9 (crispr/cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain pec211 cells.

Eligibility criteria:
inclusion criteria: * diagnosis of t1d for a minimum of 5 years * stable diabetes regimen for at least 3 months prior to enrollment. exclusion criteria: * medical history of islet cell, kidney, and/or pancreas transplant * occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment * known causes of diabetes other than t1d * immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study * prior treatment with gene therapy or edited product

Keywords: type 1 diabetes t1d allogeneic combination device crispr-cas9 cell therapy t1dm diabetes vctx
use of ultrasound to evaluate clavicle fractures in pediatric patients

Conditions: Fractures

Summary: this studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.


Eligibility criteria:
inclusion criteria: * age 1-18 years * pain from recent shoulder/clavicle injury * intact neurovascular exam * radiographs performed as part of normal ed evaluation exclusion criteria: * hemodynamic instability * multisystem trauma * altered mental status * open wounds to injured shoulder * developmental delay * prior radiographs at another clinic/hospital for this injury * previous clavicle fracture on the affected side * ultrasound gel allergy * non-english-speaking parents/child (unable to give informed consent)

Keywords: clavicle fracture ultrasound radiation