Kornimate/medical-research-clean huggingface dataset:
effectiveness and safety of pharmacopunture therapy for chronic low back pain: a pragmatic randomized controlled trial

Conditions: Chronic Low-back Pain

Summary: this is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.

this is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. participants of each group will receive total 5 weeks of intervention. this is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific type and volume of pharmacopuncture and physical therapy.

Eligibility criteria:
inclusion criteria: 1. low back pain for more than 6 months 2. numeric rating scale (nrs) score for low back pain 5 or more 3. 19-70 years old 4. participants who agreed and signed informed consent form exclusion criteria: 1. spine metastasis of cancer, acute fracture of spine, or spine dislocation 2. progressive neurologic deficits or severe neurologic deficits 3. soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc) 4. presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc) 5. concurrent use of steroids, immunosuppressants, or psychotropic medications 6. hemorrhagic disease, severe diabetes or taking anticoagulant drug 7. participants who took nsaids or pharmacopuncture within 1 week 8. pregnant or lactating women 9. participants who had undergone lumbar surgery within 3 months 10. participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial 11. participants who can not write informed consent 12. participants who is difficult to participate in the trial according to investigator's decision
effect of anti-inflammatory diet in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: in a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. the investigators also observed change in microbiome and circulating metabolites. the current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with rheumatoid arthritis, and the role of microbiome and circulating metabolites.


Eligibility criteria:
inclusion criteria: * patients with low or moderate disease activity (defined as clinical disease activity index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits. exclusion criteria: * pregnancy or lactating. patients that will become pregnant during the study will be remove from the study. * food allergies * subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results
clinical evaluation of a wheelchair mounted robotic arm

Conditions: Spinal Cord Injury

Summary: the primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (wmra) to improve the functional independence of veterans with sci. the study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm: 1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks.

the primary purpose of this project, is to evaluate the effect of a wheelchair mounted robotic arm (wmra) to improve the functional independence of veterans with sci. the study will determine if the ability to perform marker tasks within the following four categories is improved after the 4 week training period using the robotic arm: 1. activities of daily living, 2. vocational tasks, 3. advanced tasks, and subject-specific tasks. the secondary purposes of this project are the following: 1.does quality of life (life satisfaction and health status) improve after a 4 week period of using the wmra? 2. what are the perceived advantages of the wmra to the veteran with sci? additionally, the study will evaluate the following: 1) ease of installation and usefulness of instructional manuals; 2) training requirements (time, tasks); 3) safety features; 4) reliability of the device; 5) home, community, and vocational applications; 6) user acceptability; 7) maintenance/ service; 8) portability; and possible modifications.

Eligibility criteria:
patients with spinal cord injuries

Keywords: robotics; activities of daily living; spinal cord injuries
transcutaneous application of gaseous co2

Conditions: Peripheral Diabetic Neuropathy

Summary: the research is designed to evaluate influence of transcutaneous application of co2 (carbon dioxide) on peripheral diabetic neuropathy. transcutaneous application of co2 is known to have immediate effect on vasodilatation and elevates oxygen release from hb via the bohr effect. after repetition of the therapies neoangiogenesis is induced. impairment of microcirculation is one of the causes of diabetic peripheral neuropathy and improvement in circulation could have positive effect also on peripheral neuropathy. in order to evaluate the effect of transcutaneous application of co2 on peripheral neuropathy in diabetic patients the investigators designed a randomised double blind clinical trial.

transcutaneous application of gaseous co2 showed to be a successful adjuvant therapy in treatment of chronic wounds in diabetic patients (pmid: 32633896). during that research patients reported improvement in peripheral sensation after treatment. therefore, in order to investigate the influence of transcutaneous application of gaseous co2 in peripheral diabetic neuropathy the investigators designed a randomised double blind research. 60 diabetic patients with peripheral diabetic neuropathy will be randomised in study and control group. study group will receive 20 treatments with co2 (each workday for 4 weeks). lower part of the body is inserted into therapeutic wrap that is filled with 99.9% co2 gas for 45 minutes. the same approach will be used in control group but in their case the therapeutic wrap will be filled with air. in both groups investigator will evaluate vibration sensation, monofilament test and temperature of the big toe before first and after 4 weeks of treatment. patients as well as investigator (doctor) will be blind for the group belonging of the patients. the medical nurse performing all the therapies will randomise the patients using random number generator into study and control group. the nurse will be the only one knowing group belonging of the patients until the obtained results from both groups will be compared.

Eligibility criteria:
inclusion criteria: * patients with diabetes and peripheral symmetrical diabetic neuropathy * with unilateral chronic wound, without previous amputations * with scores above 3 on the michigan neuropathy scoring instrument exclusion criteria: * diabetic patients with asymmetrical peripheral neuropathy * patients with severe comorbidities: deep vein thrombosis, chronic kidney diseases grade iii and iv, chronic heart diseases nyha (new york heart association) iii and iv, patients with known malignant diseases, patients with progressive infection, signs of systemic infection with elevated inflammatory markers or osteomyelitis

Keywords: peripheral diabetic neuropathy transcutaneous co2 application
ucsd get fit, be fit study

Conditions: Overweight and Obesity

Summary: the purpose of the get fit, be fit study is to examine the effect of incorporating pistachios in an intensive 4-month cognitive-behavioral weight loss intervention in overweight and obese men and women, to examine effects on metabolic factors, and to monitor and examine changes in dietary intake and food choices during the intervention, in a randomized controlled study.

this study investigates whether pistachios help to promote weight loss and improve metabolic and cardiovascular disease risk factors in 100 overweight or obese men and women who are participating in a 4-month behavioral weight loss intervention. participants will be assigned to a cognitive-behavioral weight loss intervention and will be provided either general dietary advice as a component of the behavioral curriculum or prescribed an individualized pistachio-enriched reduced-energy diet plan. the pistachio-enriched diet will prescribe 42 g/day of pistachios, or approximately 13-20% (averaging 18%) of energy intake across a range of 1200-1800 kcal/day. dietary intake will be assessed at three time points (baseline, one month, and four months) to examine changes in dietary intake and food choices that may be indicative of compensatory intake in response to regular nut consumption. results from this study will contribute to understanding the role of pistachios in weight control, including further knowledge of the metabolic factors linked to chronic disease, and will expand knowledge of how pistachios in the diet may contribute to the prevention and management of obesity.

Eligibility criteria:
inclusion criteria: * men and women who reside in the san diego area * age 21 and older * bmi ≥ 27.0 kg/m2 and ≤40 kg/m2 * no known allergy to tree nuts * non-diabetic * non-smoker * willing and able to participate in clinic visits, group sessions, and telephone and internet communications at specified intervals * able to provide data through questionnaires and by telephone * willing to maintain contact with the investigators for 6 months * willing to allow blood collections * capable of performing a simple test for assessing cardiopulmonary fitness * willing and able to be physically active exclusion criteria: * inability to participate in physical activity because of severe disability * inability to restrict consumption of nuts for four months * history or presence of a co-morbid disease for which diet modification and increased physical activity may be contraindicated * self-reported pregnancy or breastfeeding or planning a pregnancy within the next year * currently actively involved in another diet intervention study or organized weight loss program * having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the trial. * prior to enrollment * subjects will be screened for diabetes and considered ineligible with a fasting blood glucose ≥125 mg/dl.

Keywords: nondiabetic overweight obesity men women san diego weight loss
effect of balanced hypocaloric diet associated with supplementation of eggplant meal in the remission of cardiovascular risk factors

Conditions: Obesity; Obesity, Abdominal

Summary: cardiovascular diseases (cvd) prevail as the main cause of death in developed and developing countries and are among the most frequent causes of disabilities in brazil and in the world. economic alternatives have been studied to assist in reducing cardiovascular risk factors. within this context, the solanum menogena, whose fruit known as eggplant is widely consumed in brazil, is being used in alternative medicine with the purpose to reduce the concentrations of cholesterol, glucose and promote loss of body weight. aubergine (eggplant) stands out for its high fibre content (approximately 40%) and low fat content. in addition, it is popularly known for its functional properties, aiding in reducing the risk of coronary diseases. the purplish coloring of the eggplant peel is attributed to the large amount of flavonoids, which have antioxidant properties and contribute to the flavor of eggplant. the investigators hypothesis is that the eggplant flour associated with a restricted calorie diet has effect in reduction in waist circumference, reduction of body fat and increasing hdl-cholesterol; this way, contributing to the reduction of cardiovascular risk factors all participants will be informed about the research and they will have to sign a consent form. the volunteers will be divided into two groups: one group will receive a restricted-calorie diet and supplementation with eggplant flour; and the other will receive a diet plus a placebo for 120 days, being both groups evaluated monthly. in each consultation, evaluation of weight, body composition, fulfillment of the diet and blood pressure measurement will be performed. in addition, blood will also be collected in order to determine glucose, insulin, total cholesterol, ldl, hdl, triglycerides, oxidized anti-ldl antibodies, 15-isoprostane and minerals (selenium, zinc, iron, manganese, magnesium and copper). the results will be analyzed by statistical program. the investigators expect that with the results obtained, the eggplant flour can be used as an ally in the prevention of cardiovascular diseases.


Eligibility criteria:
inclusion criteria: adults (aged\> 20 years) body mass index (bmi)\> 25 kg/m2 for both sexes, of any ethnicity. exclusion criteria: smokers, pregnant women, nursing mothers and that are performing diets and / or using drugs for weight reduction and supplements of any kind.

Keywords: oxidative stress obesity solanum melongena
non-interventional post marketing surveillance study of neovasculgen® in patients with chronic lower limb ischemia

Conditions: Lower Limb Ischemia

Summary: aim of the study is to gain more knowledge about efficacy and safety of neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with neovasculgen®.

this is an open, controlled, prospective, comparative, multicentre study design. all patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. surgical and endovascular vessel reconstruction was unsuitable for all of the patients

Eligibility criteria:
inclusion criteria: * male or female person aged 40 or older * subject with diagnosed lower limb ischemia (fontaine-pokrovsky stages iia-iii of chronic limb ischemia) * signed informed consent exclusion criteria: * any disease that can, in the opinion of the treating physician, affect the outcome of the study * patients with addictive disorders or substance abuse * pregnancy or nursing * all other exclusion criteria listed in the summary of product characteristics (smpc)

Keywords: ischemia
feasibility of a single-operator peroral cholangiopancreatioscopy system (spyglass)

Conditions: Bile Duct Strictures; Common Bile Duct Stones

Summary: cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. the advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for two endoscopists. ultraslim endoscopes later became popular as a method to digitally view the bile ducts, however, often needed guide-wire or balloon-assistance to allow for cannulation. other disadvantages of these systems included limited steerability, and poor irrigation capabilities. the advent of spyglass, a single-operator peroral cholangioscopy method allowed for a fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system. however, image quality was often lacking due to the fiberoptic technology. the new digital spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality, which will allow for better visualization and diagnosis of indeterminate strictures. furthermore, modification of the scope platform allows for efficient use, reliable directionality of the scope tip, and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement.

all patients referred for the evaluation of indeterminate strictures or removal of difficult stones will be eligible for enrollment in the consortium. the pi or study coordinator will meet with the patient and discuss the study, its objectives, and obligations with each patient. after full disclosure, informed consent will be obtained. upon consent, basic demographics and data from prior procedures (when available) will be recorded. an endoscopist proficient in ercp, with expertise in cholangioscopy, will perform the procedures using the spyglass ds system with its associated components including biopsy forceps (spybitetm) and other accessories as necessary. procedure time, visual findings, number of biopsies taken, pathology, stone location, stone size, and method of stone clearance and adverse events will be recorded on data collection forms and transferred into a centralized password protected database. all patients will be followed for 6-12 months or surgery (stricture cohort) to assess accuracy or stone recurrence rates.

Eligibility criteria:
inclusion criteria: * all patients referred for the evaluation of indeterminate strictures or removal of difficult stones. exclusion criteria: * all patients who are unable or unwilling to give consent will not be included in this study
comparing a monthly replacement lens versus a daily disposable lens

Conditions: Myopia

Summary: the purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.

this was a non-dispensing, randomized, double-masked, crossover study. participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. estimated duration of involvement for each participant was 4 hours.

Eligibility criteria:
inclusion criteria: 1. were 17 to 40 years of age and have full legal capacity to volunteer; 2. had read and signed an information consent letter; 3. were willing and able to follow instructions and maintain the appointment schedule; 4. were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye 5. were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction; 6. had an astigmatism of ≤ 0.75dc in subjective refraction; 7. could be fit with the study contact lenses with a power between -1.00 and -6.00ds; this translates to best corrected vision sphere refraction that vertexes to a cl power between -1.00 and -6.00 (inclusive) at screening visit. 8. demonstrated an acceptable fit with the study lenses. exclusion criteria: 1. had taken part in another clinical research study within the last 14 days; 2. were currently habitual wearers of toric, multifocal or monovision lenses. 3. had worn any rigid contact lenses in the past 6 months 4. were an extended lens wearer (i.e., sleeping with their lenses) 5. had a difference of ≥1.5 d in best vision sphere subjective refraction between eyes; 6. had amblyopia and/or distance strabismus/binocular vision problem; 7. had any known active ocular disease, allergies and/or infection; 8. had a systemic condition that in the opinion of the investigator may affect a study outcome variable; 9. were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 10. had a known sensitivity to the diagnostic pharmaceuticals to be used in the study; 11. had undergone refractive error surgery or intraocular surgery; 12. were a member of core directly involved in the study.

Keywords: refractive errors eye diseases
new prognostic kidney function markers in emergency patients new markers of kidney function in ed patients

Conditions: Acute Kidney Injury; Contrast Media

Summary: nephrocheck is measuring the concentration of a certain protein combination in the urine of patients. in elevated values there is a probability of renal failure (already proven in intensive care patients). the investigators would like to investigate whether the investigators can predict renal failure in patients receiving contrast enhanced ct's in the emergency department. that would lead to an earlier nephrologist consult in those patients.

the use of contrast agents can - especially in already in impaired renal function - lead to a decline in real function. the contrast enhanced ct is especially in emergency patients an important diagnostic tool for example in the detection of pulmonary embolism or mesenteric ischemia. creatinine has been used as a marker for real function so far. but the investigators all know that creatinine is not a perfect marker especially as it is influenced by age, sex, weight and muscle mass. especially in the diagnosis of acute renal failure creatinine does not allow and recent change in the kidney function. this prospective, unicentric study should therefore investigate two new markers in emergency patients who need an emergency contrast enhanced ct to early predict pending kidney function decline.

Eligibility criteria:
inclusion criteria: * patients in the emergency department who have the indication for contrast enhanced ct and a predicted hospital admission time of 48 hours or longer. exclusion criteria: * children, pregnant women * dialysis * patients with kidney transplants * patients on steroids or further immunocompromised

Keywords: emergency medicine diagnosis
biliary atresia, hepatic buffer response and sevoflurane

Conditions: Biliary Atresia

Summary: to evaluate the effects of sevoflurane on hepatic blood flow (hbf) and hepatic arterial buffer response (habr) in infants with obstructive jaundice by doppler ultrasound.twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a kasai procedure were enrolled. portal vein blood flow (pbf), hepatic arterial blood flow (habf) and hepatic blood flow (hbf) were measured by doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

children suffering from hepatobiliary disease also have an hepatic arterial buffer response (habr) with reduced portal vein blood flow (pbf) and compensatory increases in hepatic arterial blood flow (habf) which can help maintain hepatic blood flow (hbf). for infants with obstructive hepatobiliary disease, reduced hbf may affect drug metabolism and increase the risk of respiratory depression during analgesia, which can be life-threatening. to evaluate the effects of sevoflurane on hbf and habr in infants with obstructive jaundice by doppler ultrasound.twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a kasai procedure were enrolled. pbf, habf and hbf were measured by doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Eligibility criteria:
inclusion criteria: * persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly; * increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (tbil) dominated by increased direct bilirubin (dbil) (\>60%); * elevated liver enzymes; * ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis; * with radionuclide imaging confirmation of obstructed biliary excretion exclusion criteria: * concomitant cardiovascular or abdominal organ malformations