Kornimate/medical-research-clean huggingface dataset:
effects of protein supplementation on lean body mass recovery from extreme military training

Conditions: Military Operational Stress Reaction; Malnutrition (Calorie); Weight Loss; Muscle Wasting

Summary: the purpose of this study is to evaluate the physiological consequences of extreme military training and determine whether protein supplementation enhances recovery by promoting gains in lean body mass. this study will be conducted at the us marine survive, evade, resist, escape (sere) school at camp lejeune, north carolina. sere school may be an ideal setting to assess nutritional interventions that promote recovery from severe military operational stress, and identify innate or experiential variables that may lead to increased levels of resilience in warfighters. our laboratory has recently demonstrated the detrimental effects and stressful nature of sere. heart rates and stress-related hormones increased dramatically, with concomitant reductions in circulating anabolic hormones. additionally, sere causes significant weight loss (15-20 lbs), which probably included lean body mass. the effects of severe operational stress induced by sere, particularly the loss of lean mass, may degrade physical performance, increase injury risk, and compromise military readiness. under controlled laboratory conditions, consuming high protein diets or supplemental high-quality protein promotes muscle protein retention, enhances muscle protein synthesis, and protects lean body mass in response to stress. whether consuming supplemental protein promotes lean mass recovery and physiological resilience following a 'real-world' military stress has not been determined. further, the level of supplemental protein necessary to optimize recovery from extreme military operational stress has not been elucidated. up to 90 us marines will be enrolled in a 46-day double-blind, placebo-controlled trial. using complex body composition measurements, kinetic modeling of human metabolism, blood sampling and cognitive and nutrition questionnaires, the consequences of sere and the efficacy of protein recovery nutrition on lean mass accretion and warfighter resilience will be assessed. we hypothesize that consuming a specially formulated, high-quality supplemental protein ration item will speed recovery of lean body mass, physiological, and psychological resilience following extreme military operational stress.


Eligibility criteria:
inclusion criteria: * us marines at least 18 years old, enrolled in us marine sere school exclusion criteria: * self-reported allergies to dairy products
erythropoietin and/or iron sucrose for perioperative anemia management in hip and knee arthroplasty

Conditions: Anemia, Iron Deficiency

Summary: perioperative anemia is very common in patients undergoing total hip arthroplasty (tha) and total knee arthroplasty (tka). this study retrospectively analyzes the use of rhuepo and iron sucrose in patients undergoing total hip and knee arthroplasty in order to observe the short-term efficacy and safety of rhuepo and iron sucrose.

this study aims to explore whether short-term use of rhuepo and iron sucrose can improve postoperative anemia and promote postoperative rehabilitation after hip and knee arthroplasty. according to different therapies of perioperative anemia , included subjects would be divided into rhuepo monotherapy group, iron sucrose monotherapy group, rhuepo combined with iron sucrose group and control group (without rhuepo and iron sucrose).

Eligibility criteria:
inclusion criteria: 1. patients who underwent hip or knee arthroplasty between may 1, 2012 (included) and december 31, 2015 in peking union medical college hospital 2. age ≥ 18 years, sex unlimited exclusion criteria: 1. patients with serious absence of clinical data 2. patients with rhuepo contraindication 1. patients with uncontrolled severe hypertension 2. patients allergic to this product and other mammalian cell derivatives, or to human serum albumin 3. co-infected patients 3. patients definitely allergic to iron sucrose injection 4. patients with coagulation dysfunction

Keywords: tha/tka perioperative anemia rhuepo iron sucrose
causes of kinesiophobia in lymphedema

Conditions: Lymphedema

Summary: in this study, the reason for the fear of movement in patients with lymphedema will be investigated and recommendations will be given to the patients to eliminate it.


Eligibility criteria:
inclusion criteria: * those between the ages of 18-65 * to be diagnosed with lymphedema in the unilateral lower extremity * volunteering to work * not having orthopedic disorders in the lower extremities exclusion criteria: * not volunteering to participate in the research * having bilateral lower extremity lymphedema * having an active infection * having a mental cognitive disorder * being unable to communicate and cooperate

Keywords: lymphedema, kinesiophobia
half-life of plasma phytosterols in very low birth weight preterm infants with parenteral nutrition-associated cholestasis

Conditions: Liver Disease

Summary: parenteral nutrition-associated cholestasis (pnac) is one of the most common complications resulting from administration of parenteral nutrition in neonates. excess intravenous intake of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major contributing factor. to date, no information is available on plasma phytosterols half-lives in very-low-birth-weight (vlbw) preterm infants with pnac. in a prospective cohort study, plasma phytosterols (campesterol, stigmasterol and sitosterol) of vlbw preterm infants with pnac will be measured by gas chromatography-mass spectrometry (gc-ms) during pn administration and also after the stop of intravenous lipid infusion. plasma phytosterols half-lives will be calculated from the monoexponential decay curves. blood samples will be weekly collected from 1st to 12th week of life during routine metabolic tolerance analysis or gas-analysis in order to avoid burden of additional phlebotomy. samples will be collected in ethylenediaminetetraacetic acid-tubes and immediately centrifugated. plasma will be stored in pyrogallol added-tubes at -20°c until analysis. saponification reaction will be done using 5-alpha-cholestane as internal standard.


Eligibility criteria:
inclusion criteria: * 24 weeks \< gestational age \< 32 weeks; * 500 g ≤ birth weight \< 1250 g; * parenteral nutrition with vegetable oil-based lipid emulsions from the first hours of life; * diagnosis of cholestasis during vegetable oil-lipid infusion (plasma conjugated bilirubin value \> 1 mg/dl) * parental consent; exclusion criteria: * severe malformations; * inborn errors of metabolism; * severe congenital sepsis; * normal liver functions (plasma conjugated bilirubin under 1 mg/dl during vegetable oil-lipid infusion).
automatic adaptive system dialysis (aasd)

Conditions: Dialysis Intolerance

Summary: aasd is a new dialysis technique based on the use of a mathematical model of intradialytic solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and ultrafiltration rate profile. the aim of dialysate sodium and ultrafiltration rate profile is to obtain the higher stabilization of intradialytic extra cellular compartment, in consideration of end session targets: body weight and final patient's natremia. in this multicenter prospective controlled randomized trial the primary end-point is the clinical efficiency validation of aasd on intradialytic hypotension but also on thirst, cramps, headache, nausea, vomiting, hypotensive events observed in basal treatment (hd or hdf).


Eligibility criteria:
inclusion criteria:patients in hd/hdf (bicarbonate dialysis/hemodiafiltration) for at least 6 months * aged more than 18 years * on chronic thrice-weekly hd * symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week * disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment * dialysis session time: 4 hours (as much as possible) * signed inform consent form * patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min) exclusion criteria: patients in a pregnant state * patients whose life expectancy is less than study period * patients with progressive acute pathology (neoplasia...) * patients included in an other protocol * psychiatric patients or patients unable to consent or unable to follow the study
pectoralis and serratus muscle blocks

Conditions: Post Operative Pain Control

Summary: the overall research plan is pecs/sap blocks with liposomal bupivacaine improve the overall benefit analgesia score averaged over the postoperative days 1, 2, and 3. a 20% reduction on geometric means (i.e., true ratio of geometric means of 0.80) in obas will be considered the minimal clinically important benefit.

the primary aim is to determine whether a pecs/sap block, using a mixture of bupivacaine and liposomal bupivacaine, provides superior recovery compared to routine parenteral and enteral analgesia in patients recovering from mics. the primary outcome will be the simple multi-dimensional quality assessment, overall benefit analgesia score (obas score).53 our secondary aims are to: 1) compare cumulative postoperative opioid consumption (pain medications administered over one-day periods quantified as morphine equivalents and provided by the emr for the day of surgery and postoperative days 1, 2, and 3; 2) evaluate respiratory mechanics (forced expiratory volume in first minute (fev1), forced vital capacity (fvc) and peak flow) after extubation on the postoperative days 1, 2 and 3 while patients remain hospitalized; and, (3) evaluate the quality-of-recovery-15 score on the postoperative days 1, 2 and 3.

Eligibility criteria:
inclusion criteria: 1. 18-85 years old; 2. elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy exclusion criteria: 1. weight less than 50 kg; 2. pregnancy or lactation; 3. emergency surgery and patients transferred from the icu to the operating room; 4. redo cardiothoracic surgery or post-operative reoperation within 72 hours of index procedure (including minor chest wall procedures including tube thoracostomy, thoracentesis or percutaneous drain placement); 5. anticipated endotracheal intubation \> 24 hours; 6. anticipated non-study nerve block that provides analgesia to the intercostal nerves; 7. active systemic or cardiopulmonary infection; 8. mechanical circulatory support; 9. allergy or contraindication to study local anesthetics; 10. current chronic pain or routine opioid use (patients on chronic enteral opioids like percocet or vicodin) in a dose of \> 30 mg of morphine-milligram-equivalents for at least 10 days in last 30 days; 11. poorly controlled psychiatric disorders; 12. clinically important current neurologic deficit; 13. active liver disease or cirrhosis; 14. pacemaker generator or breast implants ipsilateral to surgery; 15. previous participation in this study.
the efficacy of topical mesalazine sustained-release tablets in crohn's disease patients with oral ulcer

Conditions: Crohn's Disease; Oral Ulcer

Summary: this study aims at evaluating efficacy and safety of topical using mesalazine sustained-release tablets in in the treatment of oral ulcers in patients with crohn's disease.

the study will include three phases: screening, treatment and follow-up. screening: this phase will last a maximum of 7 days and subjects eligibility will be evaluated after informed consent signature. treatment: subjects are randomly assigned to treatment and will be treated for 7 days. daily oral ulcer area and symptoms were recorded during the treatment period. a randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 6 and 8. follow-up: 28 days after the end of treatment. efficacy of treatment was evaluated by the oral ulcer remission or decreasing.

Eligibility criteria:
inclusion criteria: * age between 18\~65, both gender. * patients with oral ulcer and confirmed crohn's disease. exclusion criteria: * contraindications to study drugs. * underwent or will accept oral surgery. * patients are not able to sign the informed consent or not comply with the study protocol. * planning for pregnancy, pregnancy and lactating women. * enrolled in other clinical trials in the past 30 days. * patients with concurrent / new other serious diseases will affect the effectiveness and safety evaluation.

Keywords: oral ulcer crohn's disease
safety of novomix® 30 or levemir® for treatment of type 2 diabetics in macedonia

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to investigate the incidence of serious adverse drug reactions when using novomix® 30 (biphasic insulin aspart 30) or levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in macedonia.


Eligibility criteria:
inclusion criteria: * after the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.particular attention should be paid to the drug interactions that are listed within the product label exclusion criteria: * subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit * subjects currently being treated with biphasic insulin aspart 30 or insulin detemir * subjects who were previously enrolled in this study * subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
comparison between splint and laser in patients without disc displacement with reduction

Conditions: TMJ Disc Disorder

Summary: stabilization splint therapy and low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. this study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without reduction 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group i received combined stabilization splint and low- level laser therapy, group ii received low - level laser therapy and group iii received stabilization splint. they were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention.

objectives: stabilization splint therapy and low- level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. this study compared the effect of stabilization splint and low- level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without reduction. patients and methods: 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group i received combined stabilization splint and low-level laser therapy, group ii received low-level laser therapy and group iii received stabilization splint. they were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention. time of being normal was also evaluated.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic closed lock patients * must not be able to open their mouth exclusion criteria: * neurologic diseases * tmj pathologic lesions
radiation dose escalation study for advanced liver cancer

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this clinical study is to determine the maximum tolerated dose (mtd) of 3-dimensional conformal radiation therapy (3-dcrt)/intensity modulated radiation therapy (imrt) for locally advanced hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * pathologically confirmed or clinically diagnosed hcc * surgically unsectable or medically inoperable diseases, or surgery declined by the patient * solitary intrahepatic lesion with diameter bigger than 5 cm, without extrahepatic and/or distant metastases * associated with cirrhosis of child-pugh a * karnofsky performance status (kps) of ≥ 70 * normal renal function and adequate bone marrow reservation * tolerate active breathing control (abc) exclusion criteria: * child-pugh b or c liver cirrhosis score * previous radiotherapy to the liver * indistinct tumor boundary in ct/mri image

Keywords: hepatocellular carcinoma radiation therapy 3-dimensional conformal radiation therapy (3-dcrt) intensity modulated radiation therapy (imrt) active breathing control
predictive factors in maxillary and mandibular nerve radiofrequency treatment for trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: trigeminal neuralgia is one of the most common craniofacial neuralgias and one of the most severe types of facial pain, typically limited to the distribution of the trigeminal nerve. the first-line treatment for trigeminal neuralgia is medical therapy and primarily antiepileptic drugs. various interventional and surgical methods can be used in patients who do not respond to medical treatment or who cannot tolerate side effects. pulsed radiofrequency treatment of maxillary and mandibular nerves may provide longer-lasting pain relief in trigeminal neuralgia.this study aimed to investigate the clinical and demographic characteristics affecting treatment success in patients who underwent ultrasound-guided pulsed radiofrequency of the maxillary and/or mandibular nerves for trigeminal neuralgia.

pulsed radiofrequency treatment applied to the maxillary and mandibular nerves, which are the peripheral branches of the trigeminal nerve, is frequently used in patients with trigeminal neuralgia who do not adequately respond to medical treatment. pain intensity was evaluated at baseline and 3 months after us-guided maxillary and/or mandibular nerve prf treatment using nrs (numerical rating scale). the primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 3 months was defined as a positive categorical outcome. in addition, demographic data such as age (years), gender, duration of pain (months), etiology (idiopathic or secondary), mri findings (normal findings or abnormal findings due to conditions such as vascular compression and demyelinating plaque), pain side (unilateral or bilateral), and history of gasser ganglion rf ablation were obtained from patient data. nrs scores before and 3 months after prf were collected from the patient data and recorded. pre-procedural cranial mri and mr cisternography reports were accessed from patient records, and any abnormalities were recorded. we retrospectively analyzed the patient's electronic medical history records and the archive system containing the imaging results to obtain the variables. the main aim of this study was to determine the clinical and demographic variables associated with treatment outcomes in patients with tn who underwent prf of the maxillary and mandibular nerves. the secondary aim of this study was to determine the incidence of procedure-related adverse events.

Eligibility criteria:
inclusion criteria: * diagnosis of trigeminal neuralgia according to the ihs 3-beta criteria * no response to conservative treatment for \> 3 months * magnetic resonance imaging within 1 year prior to injection * access to clinical data exclusion criteria: * inadequate medical records with missing numerical rating scale (nrs) scores and mri images * patients lost to follow-up within three months after the procedure * history of surgery or gamma-knife radiosurgery for trigeminal neuralgia * history of malignancy

Keywords: mandibular nerve maxillary nerve pulsed radiofrequency ultrasound analgesia
a study of 48 versus 96 weeks of peginterferon alfa-2a [pegasys] treatment, with or without entecavir, in patients with chronic hepatitis b.

Conditions: Hepatitis B, Chronic

Summary: this randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \[pegasys\], with or without entecavir, in patients with hbeag negative chronic hepatitis b. patients will be randomly allocated to receive pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group a) or entecavir (0,5mg orally daily, group b) during weeks 12-36, or pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group c) or entecavir (group d) during weeks 12-36. anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. target sample size is \<500 patients.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic hepatitis b for \>/= 6 months * hbeag negative at screening * adequate renal function exclusion criteria: * antiviral therapy for chronic hepatitis b within the previous 6 months * hepatitis a, c, d or hiv infection * treatment with systemic acyclovir or famciclovir within the previous 6 months * decompensated liver disease (childs b-c) * history or evidence of a medical condition associated with chronic liver disease
iris-onyx cohort in the iris-des registry

Conditions: Coronary Artery Disease; Arterial Occlusive Diseases; Cardiovascular Diseases; Percutaneous Transluminal Angioplasty

Summary: the purpose of this study is to evaluate the relative effectiveness and safety of onyx stent compared to other (drug eluting stents) des.


Eligibility criteria:
inclusion criteria: * age 19 and more * intervention with onyx drug eluting stent * agreed with written informed consent form exclusion criteria: * intervention with onyx drug eluting coronary stent and other drug eluting stent at the same time * life expectancy of 1year and under * cardiac shock

Keywords: onyx drug eluting stent routine clinical practice angioplasty, transluminal, percutaneous coronary coronary artery disease
korean stroke cohort for functioning and rehabilitation-ii

Conditions: Stroke

Summary: korean stroke cohort for functioning and rehabilitation (kosco)-ii is a large, multi-centre prospective cohort study for all acute first-ever stroke patients admitted to participating hospitals in nine distinct areas of korea. this study is designed as a 10-year, longitudinal follow-up investigating the residual disabilities, activity limitations, and quality of life issues arising in patients suffering from first-ever stroke as previous similar stroke cohort with kosco. the main objectives of this study are to identify and compare the factors that influence residual disability and long-term quality of life in first-ever acute stroke patients with kosco. the secondary objectives of this study are to determine and compare the risk of mortality and recurrent vascular events in first-ever acute stroke patients with kosco. investigators will investigate longitudinal health behaviors and patterns of healthcare utilization, including stroke rehabilitation care. investigators will also investigate the long-term health status, mood, and quality of life in stroke patient caregivers. in addition, investigators will identify baseline and ongoing characteristics that are associated with secondary outcomes.


Eligibility criteria:
inclusion criteria: * first-ever acute stroke (ischemic stroke or intracerebral hemorrhage) with corresponding lesion and/or evidence of acute arterial occlusion on ct (a)- or mri/a-scan. * age ≥ 19 years at onset of stroke. * onset of symptoms within seven days prior to inclusion. exclusion criteria: * transient ischemic attack. * history of stroke. * traumatic intracerebral hemorrhage. * not korean.

Keywords: stroke disability function rehabilitation burden