Kornimate/medical-research-clean huggingface dataset:
implementing treatment algorithms for the correction of trauma induced coagulopathy

Conditions: Hemorrhage; Coagulopathy; Trauma

Summary: this trial compares the haemostatic effect of viscoelastic haemostatic assay (vha)-guided transfusion strategy versus non-vha guided transfusion strategy in haemorrhaging trauma patients. half of the randomised patients will receive vha-led management of bleeding, whilst the other half will receive massive transfusion protocol resuscitation using conventional coagulation tests.

trauma is the most frequent cause of death in persons aged under 40, with half of these deaths resulting from uncontrolled bleeding. 1 in 4 of all severely injured and shocked patients develop a clotting abnormality termed trauma induced coagulopathy (tic) within minutes of injury, which causes blood to continue being lost from the body faster than it can be stemmed. many more injured patients will go on to develop different types of coagulopathy at different times during the course of their treatment, either as a result of their body's ongoing response to trauma or as a consequence of their clinical care. ultimately coagulopathic patients have increased blood transfusion requirements and suffer more adverse outcomes (e.g. multi organ failure). current management of coagulopathic, haemorrhaging trauma patients comprises the unguided transfusion of large volumes of red blood cells and clotting product supplements. without rapidly available and validated diagnostics, products are delivered empirically to patients blind to the type and severity of tic they may have or indeed even if they do not have tic. this study will compare outcomes of viscoelastic haemostatic assay (vha)-guided resuscitation versus conventional management of critically bleeding trauma patients. the hypothesis is that goal-directed haemostatic resuscitation of coagulopathic bleeding trauma patients will yield improved outcomes and reduced blood product demand, compared to empiric massive transfusion therapy.

Eligibility criteria:
inclusion criteria: adult trauma patients (according to local definitions) will be enrolled if they: * present with hemorrhagic shock at any time from the time of injury until admission to the emergency department (where shock is defined by hr\>100 b/min and/or systolic bp\<90 mmhg) and activate the local massive transfusion protocol * randomized within 3 hours of injury and 1 hour of admission to the emergency department * agreement is provided on behalf of incapacitated patients by personal consultee or nominated consultee (e.g.trauma team leader) exclusion criteria: * any inclusion criteria are not met

Keywords: trauma hemostasis resuscitation coagulopathy transfusion
validation of aer-o-scope colonoscope system cecal intubation

Conditions: Colonic Polyp; Colonic Neoplasms; Colonic Diseases; Colon Adenoma; Colon Disease; Colon Adenocarcinoma; Colon Cancer

Summary: 61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. the primary outcome is cecal intubation

this will be a prospective single-center non-blinded clinical investigation. each subject will undergo a colonoscopy to the cecum with the aer-o-scope colonoscope system. all pathologies found will be removed. no control group is necessary as the main objective is to reach the cecum. either the cecum is intubated or it is not. this is true for all colonoscopy procedures. up to the first ten (10) cases for each physician will be system operation training cases. the primary endpoint of cecal intubation was chosen as this measure is the first quality objective when evaluating colonoscopy quality indicators.

Eligibility criteria:
inclusion criteria: 1. subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy 2. subject willing to undergo colon preparation bowel cleansing 3. subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60). 4. subject is able to understand and willing to sign informed consent form exclusion criteria: 1. personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (hnpcc). 2. diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases) 3. severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases) 4. history of colonic resection 5. clinically significant cardiovascular or pulmonary disease. 6. cancer or other life threatening disease or significant chronic condition that puts the subject at risk. 7. blood-clotting disorders and/or current anticoagulant therapy (subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study) 8. pregnancy 9. previous radiation therapy to the abdomen 10. morbid obesity (bmi \> 40 kg/m2) 11. drug abuse or alcoholism 12. subject is bed-ridden and/or unable to adequately communicate 13. subject is under custodial care 14. subject has a history of psychiatric disorders which would prevent compliance with study instructions 15. participation in a clinical study within the previous 30 days

Keywords: screening-colonoscopy diagnostic-colonoscopy surveillance-colonoscopy
a study to evaluate the pharmacokinetics, safety and tolerability of pf-06651600 in subjects with hepatic impairment and healthy volunteers

Conditions: Hepatic Impairment; Healthy Participants

Summary: the purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (pk) of pf-06651600 following administration of multiple once daily doses of pf-06651600. the safety and tolerability of pf-06651600 will also be evaluated in this study.


Eligibility criteria:
inclusion criteria: * willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures * body mass index (bmi) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lb) additional inclusion criteria for participants with normal hepatic function: * healthy male or female participants * no known or suspected hepatic disease additional inclusion criteria for participants with impaired hepatic function: * stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days prior to the screening visit * no other ongoing clinically significant abnormalities based on medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory tests except for the abnormal findings that are related to the participant's hepatic impairment. * satisfy the criteria for class a or class b of the child-pugh classification (mild: child-pugh scores 5-6 points, and moderate: child pugh scores 7-9 points), within 28 days of investigational product administration. exclusion criteria: * has active acute or chronic infection requiring treatment or history of systemic infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis * infection with hepatitis b, hepatitis c or hiv * any condition affecting drug absorption, distribution, metabolism and excretion (eg, status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal resection) * has malignancy, lymphoproliferative disorder, surgery or other condition not allowed per protocol additional exclusion criteria for participants with normal hepatic function: - evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease additional exclusion criteria for participants with impaired hepatic function: - has encephalopathy, severe ascites and/or pleural effusion, child-pugh score \>9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol

Keywords: pf-06651600 pharmacokinetics hepatic impairment
spg pulsed radiofrequency for chronic cluster headache

Conditions: Headache, Cluster

Summary: cluster headache (ch) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. there is a huge clinically unmet demand for an effective therapeutic method for ch. previous evidences indicate that pulse radiofrequency (prf) targeting the sphenopalatine ganglion (spg) is a safe, minimally invasive, effective treatment for ch. this randomized, controlled trial aimed to establish the safety and efficacy of spg prf for patients with chronic ch.


Eligibility criteria:
inclusion criteria: * chronic cluster headache; * at least four attacks per week; * minimum age of 18 years; * non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin. exclusion criteria: * pregnancy or breastfeeding; * presence of cardiac pacemaker or other neuromodulatory devices; * pyschiatric and cognitive disorders; * serious drug habituation or overuse of acute-headache medication; * history of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events; * infection at the puncture site; * previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.
comparison of premium monovision and bilateral implantation of trifocal diffractive intraocular lenses

Conditions: Presbyopia; Refractive Errors; Cataract

Summary: primary objective of this study is to compare two presbyopia correction surgical techniques, specificaly premium monovision, in which the dominant eye is corrected with an extended depth of field intraocular lens and the non-dominant eye with a trifocal diffractive intraocular lens, and the bilateral implantation of trifocal diffractive intraocular lenses.

two study groups will be formed. the first group will include patients who undergone premium monovision and the second will include patients who undergone bilateral implantation of trifocal diffractive intraocular lenses. patients who have undergone one of the aforementioned categories of presbyopia correction surgery will be selected in order to compare the effectiveness of these techniques by evaluating uncorrected near, intermediate and distant visual acuity, uncorrected critical print size (cps) in near and intermediate distance, dysphotopic phenomena (glare, halos) through a 4-level severity scale by patients, contrast sensitivity, the need of use glasses for all distances or separately for activities requiring near or distant vision as well as the degree of subjective satisfaction of patient via interview (nei-vfq 25). the purpose of measuring these parameters is to calculate, through a mathematical model, the relative effectiveness of each method.

Eligibility criteria:
inclusion criteria: * diagnosis of cataract with stage 2 according to the lens opacities classification system iii (locs-3) grading scale * age\>45 years exclusion criteria: * disability to understand the greek language and respond to the interview * fundus or corneal diseases * glaucoma * previous intraocular surgery

Keywords: pseudophakic presbyopic correction premium monovision trifocal diffractive intraocular lenses extended depth of field intraocular lenses
assessment of knowledge and attitude toward obstructive sleep apnea in medical teams

Conditions: OSA

Summary: obstructive sleep apnea (osa) is a serious and often underreported condition, despite its highly prevalent distribution. medical teams play an integral role in screening and managing patients with a high risk of developing osa.


Eligibility criteria:
inclusion criteria: medical teams including: * students of medical schools and dentistry * general practitioners * dentists * medical specialists * highly trained nurses (hin) exclusion criteria: * non- medical personnel's
evaluation of tranexamic acid for angiotensin-converting enzyme inhibitor-induced angioedema in the emergency department

Conditions: Angioedema

Summary: angiotensin-converting enzyme inhibitor acei induced angioedema acei-ae is defined as physical swelling of the deep skin layers or mucous membranes due to increased vascular permeability and leakage of fluid into the interstitial space caused while taking an acei

angiotensin-converting enzyme inhibitor acei induced angioedema acei-ae most commonly affects the lips, mouth, face, upper airway, and less commonly the gastrointestinal tract. this condition may lead to life-threatening airway compromise which would require emergent intubation. currently, strong evidence is lacking to help guide management of acei-ae in the emergency department (ed).

Eligibility criteria:
inclusion criteria: •patients must be ≥ 18 years old, be diagnosed with suspected acei-ae (with acei use). acei use is defined as patient-reported use or evidence indicating use listed in the chart. exclusion criteria: •patients will be excluded if they have an allergy to txa or any components of the formulation, present with an urticaria, have a personal or family history of hereditary angioedema, or received txa administration in another department besides the ed.
a study to evaluate the safety and tolerability of pf-03882845 in patients with type 2 diabetic nephropathy

Conditions: Type 2 Diabetic Nephropathy

Summary: pf-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. the primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of pf-03882845 in this population.

this study was terminated on 12-sep-2012; this decision was made due to poor recruitment and overall business strategy. the study was not terminated for safety reasons nor for lack of efficacy.

Eligibility criteria:
inclusion criteria: * males and/or females between 18-65 years, inclusive. * body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb. * have type 2 diabetes mellitus. * on stable dose of anti-diabetic and anti-hypertensive medication prior to screening. exclusion criteria: * recent evidence or medical history of unstable concurrent disease. * cardiovascular event within 3 months prior to screening. * history of renal transplant. * history of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.

Keywords: type 2 diabetes mellitus. albuminuria.
integrating caregiver support into ms care

Conditions: Multiple Sclerosis

Summary: with loss of mobility in multiple sclerosis (ms) comes an increase in amount and types of caregiver assistance, with a concomitant increase in burden for the caregiver. in fact, effect on caregiver burden can be seen as a potential indicator of the efficacy of ms management, suggesting that the caregiver is an appropriate and independent target for ms therapeutic strategies. ms patients report difficulty implementing and continuing with home exercise, mobility, and walking programs. this feasibility study will test integration of a successful behavioral caregiving intervention into clinical practice to improve functioning of veterans with multiple sclerosis (ms) and their caregivers. caregivers of veterans with ms will receive a behavioral caregiver intervention designed to address caregiver coping and management of patient concerns, with special focus on patient mobility and walking. a pre-post intervention design will compare outcomes for veterans and caregivers. for veterans, the intervention will target caregiver participation in home-based veteran mobility activities. ms caregivers report high burden, stress, and depression involved in caring for their loved ones, especially as mobility declines and these outcomes are related to physical and emotional health status of the patient. for caregivers, the intervention will focus on improving caregiver coping and on managing ms-related problems. outcomes for both will be measured at baseline, 3 months, and 6 months. study objectives include: * test whether a caregiver intervention can be integrated into an ms clinical setting. * determine whether caregiver outcomes are improved (depression, burden, anxiety, and number of veteran ms problems and safety alerts reported). * determine whether veteran outcomes are improved (expanded disability status scale, timed up and go test, self-efficacy, and depression). * determine which types of caregivers will benefit most. * determine which types of veterans will benefit most. * refine materials for future clinical research, translation and implementation.


Eligibility criteria:
inclusion criteria: * veteran being seen in ms clinic at memphis va * veteran ambulatory * caregiver/care partner who agrees to participate exclusion criteria: * none

Keywords: caregivers activities of daily living
immediate effects of a 10-minute body scan meditation on people who has central sensitization

Conditions: Chronic Pain

Summary: for patients with chronic pain, how does a 10 minute guided body scan meditation affect pressure pain threshold and extent of pain on a body diagram?

patients who present with central sensitization in physical therapy will go through a 10 minute body scan meditation. if patient meets criteria then they will fill out pre-intervention measures including hand dominance, gender identity, duration of pain, work status, pain body diagram, current pain level, previous medication and a neck disability index or an oswestry disability index. subject will then be asked what position they feel most comfortable to be led through this body scan meditation. after the meditation, the participant will fill out another pain body diagram, current pain level, global rating of change and pain pressure threshold. at this point the study is over and the subject will return to their physical therapy treatment.

Eligibility criteria:
inclusion criteria: * subjects are from a convenience sample of patients seeking physical therapy care from a physician referral or direct-access to a privately owned physical therapy clinic english speaking * central sensitization inventory \> 40 * subject complains of disproportionate non mechanical unpredictable pattern of pain provocation in response to multiple non-specific aggravating/easing factors * pain disproportionate to the nature and extent of injury or pathology * strong association with maladaptive beliefs and pain behaviors * diffuse, nonanatomic areas of pain and tenderness on palpation exclusion criteria: * does not meet the criteria above

Keywords: central sensitization meditation
study of ultrasonographic cava femoral ratio in the critically ill patient with shock

Conditions: Hemodynamic Instability

Summary: this study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease.

among patients presenting with severe abdominal disease and shock, observations shown that the diameter of the common femoral vein was larger than the inferior vena cava. the hypothesis is that this observation could be secondary to a compression of the inferior vena cava related to an increased intra abdominal pressure.

Eligibility criteria:
inclusion criteria: * adult * need for icu admission * need for vasopressor (epinephrine or norepinephrine) to obtain a mean arterial pressure at least of 65 mmhg exclusion criteria: * deep venous thrombosis related to inferior vena cava or common femoral veins * inability to measure inferior vena cava and common femoral vein diameters using ultrasonography

Keywords: intra abdominal hypertension shock critically ill
crossover versus stabilometric platform in parkinson's disease

Conditions: Parkinson's Disease

Summary: the aims of this study is to assess the efficacy of the crossover on balance in parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform.

parkinson's disease (pd) is a neurodegenerative disorder characterized by different motor symptoms (rigidity, akinesia, tremor and impairment of balance and gait). even though pharmacological treatment has changed the natural course of the disease, balance worsens over time and leads to falls. the aims of this study is to assess the efficacy of the crossover (group 1) on balance in parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform (group 2). the group 1 executed 6 days/week for a 4-weeks cycle a crossover protocol based on the first 4 level of resistance and a training which lasts at most 5 minutes. the group 2 executed 6 days/week for a 4-weeks cycle different exercises with the stabilometric platform in monopodalic and in bipodalic standing.

Eligibility criteria:
inclusion criteria: * pd in stage iii hoen\&yahr according to gelb et la. with the ability to walk without any assistance and with mini mental state examination (mmse) score \> 26 exclusion criteria: * mmse \< 26 * coexistence of other neurological diseases * pd patients with relevant orthopedic, rheumatic and muscular conditions

Keywords: balance
the effect of anemia in infancy on the microbiome and systemic metabolism

Conditions: Anemia; Iron-deficiency; Iron Deficiency Anemia

Summary: serum and fecal samples were collected from infants at either 6-7 m of age or 12-13 m of age. serum and feces were analyzed locally for hemoglobin status or evidence of parasites, and standard of care was provided. excess serum was transported to uc davis for metabolomics analysis and the university of hohenheim for iron status assessment and measurement of inflammatory markers. fecal samples were transported to uc davis for measurement of the microbiome structure and function.

sample collection occurred between august and november 2014. a total of 203 infants and their parents (101 at 6-7 m of age and 102 at 12-13 m of age) receiving care at the moronacocha health center in iquitos, peru were recruited. all subjects were residents of moronochocha, iquitos, loreto, outwardly healthy, and born at term with a birth weight of at least 2,500 g. venous blood samples were collected by a lab technician at the local health center. hemoglobin concentrations were immediately measured, and treatment given if warranted. samples were subsequently transported to selva amazonica clinic, centrifuged, and serum was stored at -80 °c. stool samples were collected by caregivers from diapers at home, taken to selva amazonica clinic, and aliquoted. fecal samples were analyzed for parasites at selva amazonica, and any necessary treatment was provided at the local health center. serum and stool samples were shipped to uc davis on dry ice, where they were stored at -80 °c until metabolomics and microbiome analyses. serum aliquots were also shipped to the university of hohenheim, stuttgart, germany for iron assessment, and measurement of inflammatory markers. all data integration and interpretation was performed at uc davis.

Eligibility criteria:
inclusion criteria: * outwardly healthy, * birthweight \> 2,500 g * term births * residents in moronacocha, iquitos, loreto exclusion criteria: * obvious signs of illness or malnutrition * birthweight \< 2,500 g * preterm birth * not a resident of moronacocha, iquitos, loreto

Keywords: anemia iron-deficiency iron-deficiency anemia infants metabolomics microbiome