Kornimate/medical-research-clean huggingface dataset:
obesity in g60 trauma patients / obesity in g60 trauma patients

Conditions: Obesity

Summary: obesity is a national epidemic that affects all aspects of health care, including trauma care. according to the centers for disease control and prevention, 1% of us adults 20 years old and older are obese (body mass index \[bmi\], calculated as weight in kilograms divided by height in meters squared, \> 30), and 69% are overweight (bmi \> 25) (1, 2). obesity is a major health concern because of its established relationship with serious medical diseases and increased likelihood of comorbid conditions (eg, diabetes mellitus, hyperlipidemia, heart disease, pulmonary disease) (3). as the number of obese adults continues to increase, the potential number of obese trauma patients with severe injury and complications will also increase (3). management of prehospital and in-hospital trauma care, including complications associated with airway management, surgical procedures, and radiological imaging, of obese patients can be challenging. however, published reports on how obesity complicates hospital stays after trauma are conflicting (4, 5). several studies have indicated that obese trauma patients are more likely than non-obese patients to have longer stays in the intensive care unit (icu) and hospital, more days of mechanical ventilation, more complications, and comorbid conditions, and higher mortality (6,7,8). other studies have indicated no differences between obese and nonobese patients in mortality, length of stay in the icu and the hospital, duration of mechanical ventilation, complications, or comorbid conditions (9). accordingly, the main aim of this study is to investigate and compare hospital course, clinical outcomes, disposition, and the cost of treatment between geriatric obese and non-obese patients hospitalized for treatment of traumatic injuries.

this proposed research is a retrospective chart review to determine if trauma patients with different body mass indexes differed in hospital course, clinical outcomes, disposition, and the cost of treatment. records of trauma patients who were admitted to mhs between january1st 2006 and june 30th 2016 will be retrieved to review the clinical charts according to the investigator's inclusion and exclusion criteria. basic demographics and clinical outcomes parameters as noted above will be attained from the patient's medical records.

Eligibility criteria:
inclusion criteria: 1. male and female patient's ≥ 60 years of age. 2. blunt and penetration injury. exclusion criteria: 1. pregnant and breastfeeding women. 2. patients \< 60 years of age
gonadotropin-releasing hormone (gnrh) downregulation versus oral anticonception prior to art in postoperative endometriosis patients

Conditions: Endometriosis; Infertility

Summary: does prolonged gnrh downregulation prior to art improve the clinical pregnancy rate in postoperative endometriosis patients? (a single centre randomised controlled trial)


Eligibility criteria:
inclusion criteria: * histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy * only first three art cycles * normal uterine cavity * eligible for ovarian stimulation with long agonist protocol exclusion criteria: * fsh\>20 iu/l * presence of large intramural fibroids (\> 3 cm) * \<4 oocytes obtained in any previous fresh art cycle * art with sperm derived from testicular biopsy * art with preimplantation genetic diagnosis/screening

Keywords: endometriosis infertility assisted reproductive technology
ed90 determination of carbetocin for the prevention of uterine atony in women undergoing an elective cesarean delivery

Conditions: Postpartum Hemorrhage; Uterine Atony

Summary: the purpose of this trial is to determine the effective dose of carbetocin which would prevent the occurrence of postpartum uterine atony in 90% of women undergoing an elective cesarean delivery.

postpartum hemorrhage is a major cause of maternal morbidity and mortality worldwide. carbetocin have been shown effective in the prevention of uterine atony, which is the leading cause of postpartum hemorrhage. the society of obstetricians and gynecologists of canada recommends a single 100 mcg dose of carbetocin after elective cesarean delivery to prevent postpartum hemorrhage. however, there is no clear data in the literature regarding the lowest effective dose of carbetocin that should be administered. the use of the minimum effective dose of carbetocin may reduce its side effects, including hypotension, tachycardia, nausea, vomiting and flushing. in this trial, healthy term pregnant women undergoing elective cesarean delivery under spinal anesthesia will be recruited. the effective dose of carbetocin that will prevent postpartum uterine atony in 90% of the women (ed90) will be determined using a biased coin design up-down sequential allocation method. the determination of the carbetocin ed90 will help the anesthesiologist regarding the optimal dose of carbetocin to administer after elective cesarean delivery to prevent uterine atony.

Eligibility criteria:
inclusion criteria: * healthy pregnant women (asa i or ii) * elective cesarean delivery * spinal anesthesia * term gestation (37 weeks and above) exclusion criteria: * multiple gestation * known coagulopathy * active labour * uterine fibroids * body mass index \> 45 * emergency cesarean section * general anesthesia * any contraindication to neuraxial anesthesia * cardiopathies * known allergies to carbetocin * patient refusal * placenta previa/placenta accreta * hypertensive disease/preeclampsia/eclampsia * polyhydramnios * previous history of uterine atony or postpartum hemorrhage * renal or liver disease

Keywords: postpartum hemorrhage uterine atony obstetric anesthesia cesarean section carbetocin
resistive/cardiovascular training study

Conditions: Muscular Atrophy

Summary: this is a training study in healthy volunteers to characterize gains in lower-body resistive strength and cardiovascular capacity with exercise on a combined countermeasure device (ccd) we have developed for the national space biomedical research institute. the ccd is a single platform which contains interchangeable modules for cardiovascular stepping exercises and lower body resistive exercises including squats, heel raises, abductor and adductor exercises and knee extension and flexion. the platform has the capability to tilt, yaw and pitch, and to translate in three dimensions in order to challenge the neurovestibular system. the underlying goal of the project is to provide a compact and efficient exercise modality that will prevent deterioration of the cardiovascular and musculoskeletal systems, and the neurovestibular system, in long-duration spaceflights. the goal of the current study is simply to test the hypothesis that in healthy volunteers, the exercise prescription proposed for the device will improve strength and vo2 max. subjects are tested for lower body resistive strength and v02max at baseline, then are trained for 12 weeks, and tested again at followup to test for a change. 36 subjects, allowing for a 20% attrition rate, allows sufficient power to detect 95% percent confidence intervals in the changes in the strength and v02max measures of roughly 10-20%. if we observe gains in these indices which are similar to those reported in the literature for simultaneous cardiovascular and resistive strength protocols, then we believe that there is sufficient evidence to test ccd in a bedrest model of long-duration spaceflight.


Eligibility criteria:
inclusion criteria: * healthy men and women * 25-55 years old * do not exercise on a regular basis exclusion criteria: have not been diagnosed with hypertension, diabetes, high cholesterol, cardiovascular disease or asthma and other pulmonary disorders
bone marrow autograft in limb ischemia

Conditions: Peripheral Vascular Diseases

Summary: bali (bone marrow autograft in limb ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option. the main end point is the survival without major amputation 6 months after implantation. biological studies are performed on bone marrow mononuclear cells (bm-mnc) to evaluate their angiogenic properties.

one hundred and ten patients with critical leg ischemia and no surgical option will be included. a bone marrow harvest (500 ml under general anaesthesia) is performed and bm-mnc are separated and concentrated (30 ml) for all included patients. for half of them, the bm-mnc are implanted on the same day whereas the others are implanted with a placebo cell-product (30 ml saline with 4 ml peripheral blood). for these patients the bm-mnc are cryo-conserved. only the cell therapy unit, neither the patient, nor the clinician, know whether bm-mnc or placebo is implanted. the main end point is the survival without major amputation 6 months after implantation. after this delay it is possible to use previously cryo-conserved bm-mnc. likewise biological studies are performed on bm-mnc: flow-cytometry analysis of progenitor cells content, proteins and mrnas expression, induced angiogenesis in animal models.

Eligibility criteria:
inclusion criteria: * critical limb ischemia * no possible surgical treatment exclusion criteria: * ongoing infectious disease * gangrene extending beyond the digits * diabetes mellitus with hba1c \> 7.5% or with proliferative retinopathy * history of malignant disease * contra-indication to general anaesthesia * chronic haemodialysis * prothrombin time \< 50% * recent onset (within 3 months) of myocardial infarction or brain infarction * contra-indication to modification of anti-platelet or anticoagulant therapy * history of heparin-induced thrombocytopenia * unexplained haematological abnormality

Keywords: limb ischemia cell therapy
the reach and effectiveness of technology-enhanced diabetes prevention programs

Conditions: Diabetes Prevention

Summary: the aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. the overall aim is consistent with the niddk's behavioral/prevention research program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. while evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge. the proposed research project will conduct a pragmatic clinical trial that employs a hybrid preference/randomized controlled trial (rct) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs. adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the choice group or the randomization group. those patients randomized to the choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1. a 2-hour small-group (sg) session, with automated interactive voice response (ivr) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. a dvd-based intervention with the same ivr follow-up. those patients assigned to the rct group (n=360) will be randomized to one of three groups: 1. sg/ivr; 2. dvd/ivr; or 3. enhanced standard-care (sc). sc includes the referral to a currently offered pre-diabetes class. primary outcome measures include weight loss, cost, and reach of each program. secondary outcome measures include physical activity behavior; eating behavior; and process evaluation. it is hypothesized that both the sg/ivr and the dvd/ivr interventions will produce significantly greater amounts of weight loss at 6, 12, and 18 months following program initiation than sc but will not differ from one another. the investigators also hypothesize that the dvd/ivr will have broader reach and may be more cost-effective than sg/ivr or sc.


Eligibility criteria:
inclusion criteria: * age = or \> 18 years * bmi = or \> 25 exclusion criteria: * patient's medical record contains icd-9 codes for a diagnosis of any type of diabetes, congestive heart failure or coronary artery disease * pregnant or becomes pregnant during trial * contraindication to physical activity or weight loss * no access to phone * does not speak or read english * patient has indicated "do not contact" in carilion patient record

Keywords: diabetes prevention
blood flow quantification near stented sfa lesions using ultrasound velocimetry

Conditions: Peripheral Arterial Disease

Summary: peripheral arterial disease (pad) in the lower extremity is the third leading cause of atherosclerotic cardiovascular morbidity. endovascular treatment has become the principal surgical strategy in femoro-popliteal lesions. stent placement induces significant changes in the arterial geometry and thereby in the hemodynamic environment. visualization of local blood flow patterns (around stents) is challenging, but clinically relevant. blood flow has a significant influence on the development of atherosclerosis and therefore stent patency. in vivo blood flow characterization might enable the recognition, prediction and explanation of (in-stent) restenosis. this study will therefore aim to investigate the feasibility of a novel ultrasound technique (echopiv) to quantify spatiotemporal blood flow near stented femoral artery lesions. furthermore, the blood flow information obtained during the echopiv measurements will be used as patient-specific boundary conditions in a computational fluid dynamics (cfd) simulation. the tested hypothesis is that blood flow quantification using echopiv is feasible in and around stents in the femoral artery and that it will improve cfd simulations.


Eligibility criteria:
inclusion criteria: * scheduled endovascular treatment of a lesion in the sfa through placement of a bare metal or a covered stent * a recently (\<6 weeks) treated lesion in the sfa through placement of a bare metal or a covered stent exclusion criteria: * hypersensitivity to the active substance(s) or any of the excipients in sonovue * right-to-left cardiac shunt * severe pulmonary hypertension (pulmonary artery pressure \> 90mmhg) * uncontrolled systemic hypertension * adult respiratory distress syndrome * severe pulmonary disease (e.g. copd gold 3/4, adult respiratory distress syndrome) * clinically unstable cardiac disease (recent or ongoing myocardial infarction, unstable angina at rest, recent percutaneous coronary intervention, clinically worsening cardiac symptoms, severe cardiac arrythmia's, endocarditis, etc.) * prosthetic valves * loss of renal function (gfr \< 31 ml/min), end-stage renal disease * end-stage liver disease sepsis * hypercoagulable status, recent thrombosis * congestive heart failure (class iii or iv) * hypersensitivity to iodinated contrast media * pregnancy
intravascular volumes in hypoxia during antarctic confinement

Conditions: Hypoxia; Confinement

Summary: this study evaluates the effect of hypoxia on blood volumes during antarctic winter-over confinement. half of the participants will be evaluated during sea-level winter-over confinement, while the other half will be examined during high-altitude hypoxia winter-over confinement.

introduction: short-term space flight induces an alteration of circulating blood volumes, termed "space flight anemia" and characterized by a decrease in total red blood cell volume (rcv) and plasma volume (pv). this haematological alteration is likely to persist during a long-term space mission and impact the astronauts' health, however this question remains unexplored. during a long-term space mission, the use of hypobaric hypoxia is considered for technical reasons, however the safety of hypoxia must first be verified because this environmental condition causes substantial physiological changes, in particular changes in blood volumes that may interact with the haematological effects of microgravity. objective: using the antarctic confinement model as a high-fidelity terrestrial analogue for long-duration space missions, the investigators hypothesize that 1) sea level confinement reduces blood volume by simultaneously decreasing rcv and pv, and 2) chronic hypoxia offsets the decrease in rcv and exacerbates the decrease in pv induced by confinement. methods: blood volumes will be measured via the carbon-monoxide rebreathing method, repeatedly in two groups of participants, overwintering either at dumont d'urville (sea level) or concordia (altitude 3200 m). the blood viscosity will also be measured, as well as the markers of erythropoiesis and iron metabolism. perspective: documenting if some degree of hypoxia during long-duration confinement may be beneficial or unfavorable in terms of blood volume regulation is potentially relevant information for the astronauts' health and safety during long-duration space missions.

Eligibility criteria:
inclusion criteria: * affiliated to a social security scheme * ability to communicate and read in english or in french * signed written informed consent form after visit with a md exclusion criteria: * pregnant, lactating or parturient women * cardiovascular, pulmonary or neuromuscular disease * vulnerable persons

Keywords: total red blood cell volume plasma volume total hemoglobin mass total blood volume
biomarkers and cardiac ct

Conditions: Coronary Artery Disease; Atherosclerosis

Summary: coronary artery disease (cad) is the leading cause of morbidity and mortality in developed countries. in addition, many patients suffer from valvular and aortic disease. although various tools are available to identify patients with cardiovascular (cv) disease at risk for major adverse cardiac events (mace), the identification of these patients remains a clinical challenge. one promising avenue is the use of different serum biomarkers involved in atherothrombosis which could provide an easy and cost-effective step in risk stratification.


Eligibility criteria:
inclusion criteria: * patients referred from the cardiology clinic for routine ccta. exclusion criteria: * pregnancy * severe renal insufficiency * severe allergy to contrast medium * inability to obtain informed consent * age below 18 years

Keywords: biological markers multidetector computed tomography
comfortage - ad prevention strategies

Conditions: Alzheimer Disease; Subjective Cognitive Impairment; Mild Cognitive Impairment

Summary: study is interventional, cross-sectional, clinical trial without drug and without device


Eligibility criteria:
inclusion criteria: * subjective cognitive decline, defined as self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; normal performance on standardised cognitive tests adjusted for age, sex, and education; decline cannot be explained by psychiatric or other neurologic disease, medical disorder, medication, or substance use; no functional impact on daily life activities * mild cognitive decline, defined as persistent decline in cognitive performance (in comparison with a previous status) reported by the subject or by an informed caregiver; or observed by change on longitudinal cognitive testing; cognitive performance below expected range for that individual based on cognitive test performance (adjusted for age, sex, and education); performs daily life activities independently (but cognitive difficulty may result in detectable but minimal functional impact on the more complex activities of daily life, either self-reported or corroborated by a study partner); clinical dementia rating scale = 0.5 * ability to sign and understand the informed consent form exclusion criteria: * age under 50 or over 85 years * non-native italian speakers * non degenerative and secondary forms of dementia * previous or current participation in clinical trials with anti-amyloid agents
use of an investigational digital therapeutic in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: bt-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control (i.e., levels of blood sugar). the bt-001 software delivers a type of behavioral therapy to patients via a mobile application that targets behaviors related to achieving glycemic control. the effectiveness of bt-001 will be measured by its ability to help patients reduce hemoglobin a1c, or hba1c (a marker in the blood that measures blood sugar) in patients with type 2 diabetes.

the study will utilize an open-label, pragmatic design to confirm and characterize the safety and efficacy of bt-001 used in addition to standard of care (soc) in patients with type 2 diabetes. the screening period will consist of review of electronic health record (ehr) for participants that meet inclusion criteria and telephonic outreach. once confirmed consented, patients will then be given access to bt-001 for 90 days with an opportunity to continue using the product for an additional 275 days. participants will continue their standard of care with their provider in addition to using bt-001.

Eligibility criteria:
inclusion criteria: * diagnosis of type2 diabetes * possess a smart phone (iphone or android only) capable of running the smart phone application (app) used in the study; * hba1c level ≥7% and \<11%, as determined by the hba1c measured within the previous 12 months; * willing to use a glucometer for self-monitoring blood glucose while using the study app; * capable of giving informed consent in english, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * unable to understand, consent to, or comply with the study protocol for any reason, including the inability to read or comprehend english. the behavioral intervention mechanisms, including educational materials and digital tools, are only available in english at this time; * currently taking prandial (mealtime) insulin; * currently experiencing heart failure of new york heart association class iv; * currently experiencing stage 4 or 5 chronic kidney disease; * currently on kidney dialysis (hemo or peritoneal); * currently on the list for an organ transplant or previously received a transplant of any organ; * currently receiving treatment for cancer; * for women only: pregnant or lactating or having the intention of becoming pregnant during the time frame of the study; * presumed or confirmed covid-19 diagnosis within 90 days prior to study enrollment