Kornimate/medical-research-clean huggingface dataset:
resistance training and diet in patients with chronic renal failure

Conditions: Kidney Failure, Chronic

Summary: this study will examine the effects of long-term adherence to a low protein diet (lpd) of 0.6 g/kg-1/d-1 with and without progressive resistance exercise training in patients with impaired renal function on body composition, renal function (glomerular filtration rate), nitrogen balance, muscle strength and size, and functional capacity. the hypothesis is that adherence to a lpd will result in a reduction in skeletal muscle mass and reduced strength and functional capacity while those patients who adhere to the lpd and exercise will demonstrate a similar preservation of renal function but will have greater fat free mass, muscle mass and strength. the intervention trial will last 18 months in which patients with moderate renal failure will be randomly assigned to one of 4 interventions: standard care, standard care + exercise, lpd, and lpd with exercise. in this way the independent and combined effects of diet and exercise on the progression of renal disease and body composition will be monitored. this study will have important implications for the treatment of patients with chronic renal failure. new strategies of combining exercise with recommendations of a low protein diet may slow the progression of renal disease and improve strength and functional capacity in these at-risk patients.

management of dietary protein intake of the crf patient represents a critical balance between providing adequate protein to meet nutritional requirements, and limiting protein intake in the hope of slowing or abating the progression of crf. a number of studies have demonstrated that reduced dietary protein intake can slow the progression of chronic renal failure. finding effective ways to increase nitrogen retention and decrease urinary nitrogen excretion may help crf patients maintain a more positive nitrogen balance and lessen the nitrogen load on the kidneys for a given dietary protein intake. our laboratory has demonstrated that in older men and women, the consequence of adherence to a low protein diet is an accommodation that results in decreased muscle mass, strength,and compromised immune function. we have also demonstrated that when healthy, free living older men and women consume a weight maintenance diet providing the rda for protein of 0.8 g/kg-1/day-1 for 15 weeks they lose skeletal muscle mass. these data clearly indicate that elderly people have an increased need for dietary protein (compared to young people). data has also demonstrated that progressive resistance exercise improves nitrogen balance in older healthy individuals as well as in patients with mild to moderate chronic renal failure.

Eligibility criteria:
* men and women 50-89 years with chronic renal failure (defined as creatinine clearance of 25-65). * volunteers must be able to fulfill the requirements associated with this protocol. * volunteers may be hypertensive and/or diabetic.

Keywords: diet exercise
study of a primary care hypoglycemia prevention program

Conditions: Diabetes Mellitus; Hypoglycemia

Summary: this is a single site, pre-post pilot study. the objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. the study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial.


Eligibility criteria:
inclusion criteria for patients: * age 18 years or older * diabetes mellitus by electronic health record review * treatment with any of the following medication classes: insulin, sulfonylureas, meglitinides * community dwelling (not residing in long-term care or a skilled nursing facility) * receiving primary care from a participating primary care provider at johns hopkins internal medicine at green spring station * the patient's primary care provider approves their participation exclusion criteria for patients: * significant cognitive impairment or dementia * receiving hospice or end of life care * any other serious illness or condition not compatible with participation as determined by the investigators * planning to leave area prior to end of study * investigator discretion exclusion criteria for continuous glucose monitoring (not required for study participation): * history of allergic skin reaction to adhesive * implantable pacemaker inclusion criteria for primary care providers: * practicing at johns hopkins internal medicine green spring station exclusion criteria for primary care providers: * planning to leave their position prior to end of study * not serving as primary care provider for any included patient inclusion criteria for clinic staff: * participating in check-in at johns hopkins internal medicine green spring station exclusion criteria for clinic staff * planning to leave their position prior to end of study
icotinib as first-line and maintenance treatment in egfr mutated patients with lung adenocarcinoma

Conditions: EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma

Summary: this study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

this study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib. primary endpoint: progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib secondary endpoint: 1. overall survival between icotinib and chemotherapy 2. time to progression between icotinib and chemotherapy 3. objective response rate and disease control rate between icotinib and chemotherapy

Eligibility criteria:
inclusion criteria: * pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on ct); patients must have previously untreated locally advanced or metastatic nsclc; patients must have lung cancer with a documented egfr activating mutation (exon 19 deletion, l858r). exclusion criteria: * prior chemotherapy prior treatment with gefitinib, erlotinib, or other drugs that target egfr patients must not be receiving any other investigational agents any evidence of interstitial lung disease

Keywords: icotinib egfr positive mutation first-line treatment maintenance treatment
efficacy and safety of shinbaro capsule

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the efficacy and safety of 'shinbaro capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * age between 35 and 80 * diagnosed with knee oa based on criteria of acr and showed ont through i \~ iii of kellgren stage on radiography * wuffered constantly with knee oa for more than 6 months prior to begining the study * scored more than 30 on total womac scale exclusion criteria: * had other comorbid orthopedic disease * had oa of index knee from significant trauma or surgery

Keywords: osteoarthritis
an open-label, multiple dose study to evaluate the pharmacology, safety, and tolerability of patiromer in participants on hemodialysis

Conditions: Hyperkalemia

Summary: this study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

the initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study. this was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. eligible participants on hemodialysis were to remain in the clinical research unit for 2 weeks (day -7 to day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Eligibility criteria:
inclusion criteria: * participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/l * adequately dialyzed (kt/v ≥ 1.2) exclusion criteria: * history of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery. * severe constipation or irregular bowel habits. * unable to consume or tolerate the study-specific diet.
safety and efficacy of the sentinel cerebral protection device in atrial fibrillation ablation

Conditions: Arrhythmia; Atrial Fibrillation

Summary: the purpose of the study is to see if the sentinel® cerebral protection system may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (af). the secondary purpose of this study is to study if cognitive function after af ablation differs between those treated with the sentinel cerebral protection device and those who do not receive the device.

if assigned to receive the device, the sentinel® cerebral protection system will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. the study team will then call you 30 days after your procedure to assess any neurological events. your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.

Eligibility criteria:
inclusion criteria: * men / women over the age of 18 years undergoing radiofrequency, pulsed field or cryo-balloon ablation for af in accordance with the current aha/acc/hrs guideline for management of patients with atrial fibrillation. this includes patients with symptomatic paroxysmal, persistent or long-standing persistent af not responsive to or intolerant of a class i or iii anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent af prior to the initiation of a class i or class iii antiarrhythmic drug). the decision to perform catheter ablation for af will be made by the treating provider and the patient in accordance with the guidelines noted above. (january et al. j am coll cardiol vol. 64, no. 21, 2014, page e1) * able to provide informed consent. * patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure ct angiogram. exclusion criteria: * anatomy unsuitable for use of sentinel device: * right extremity vasculature not suitable due to compromised arterial blood flow. * brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (\>70%), dissection or aneurysm. * cerebrovascular accident or transient ischemic attack within six months * carotid disease requiring treatment within six weeks * unable or unwilling to provide informed consent. * pregnant women * known history of dementia. * known hypersensitivity to nickel-titanium. * presence of mri non-compatible implanted devices including cardiac implantable electronic devices. * the presence of left atrial thrombus. all patients routinely undergo transesophageal echocardiogram prior to ablation and / or intra-cardiac echocardiogram at the beginning of the ablation procedure to rule out the presence of left atrial thrombus. * patients with a reversible cause for af such as hyperthyroidism.
kidnet vs meditation/relaxation - a dissemination randomized controlled trial for the treatment of traumatized children after war in sri lanka

Conditions: Post-Traumatic Stress Disorders

Summary: the purpose of this study is to assess the efficacy of kidnet versus a meditation/relaxation protocol in treating traumatized children when applied by locally trained teacher counsellors as well as the effectiveness and adequacy of such a treatment in a south-asian war affected stayee child community.

outcome measures include ptsd symptom score, depression score, suicidal ideation and related functioning measures (including school grades)

Eligibility criteria:
inclusion criteria: * all children with ptsd diagnosis from six surveyed schools in vallikamam/jaffna educational zones age range 11-15 exclusion criteria: * none

Keywords: ptsd depression suicidality trauma-focussed treatment kidnet narrative exposure therapy for children meditation relaxation war
effect of intravenous lidocaine on the tolerability of early oral feeding after laparoscopic colorectal surgery

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer. * degree of nausea/vomiting. * degree of postoperative pain and opioids requirement. * time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.


Eligibility criteria:
inclusion criteria: * elective laparoscopic colorectal surgery for colorectal cancer. * age \> 18 years. * informed consent. exclusion criteria: * allergy to local anesthetics. * severe cardiovascular, hepatic, or renal diseases. * pregnant or lactating patients. * emergency surgery. * american society of anesthesiologists (asa) class iv

Keywords: colorectal cancer laparoscopic surgery postoperative ileus lidocaine early oral feeding
the effect of clinical monitoring software on symptoms in patients with chronic low back pain

Conditions: Musculoskeletal Pain

Summary: the aim of this randomised controlled trial is to compare the effectiveness of two different telerehabilitation assessment methods in patients with chronic low back pain. the control group will receive a video exercise-based rehabilitation protocol with telerehabilitation. the intervention group will be followed up with the same protocol plus symptom monitoring software called physioanalyst which provides visual feedback. the evaluation of outcome measures will be performed on the control group through the physioanalist programme without visual feedback and on the intervention group through the physioanalist programme with visual feedback.

individuals with chronic low back pain will be divided into 2 groups by randomisation software (https://ctrandomization.cancer.gov/tool/). the control group will be given video exercises on the online platform. initial, interim and final evaluations will be performed by filling in the patient-reported outcome measures through the physioanalyst programme without patient feedback. the intervention group will be given the video exercise programme on the same online platform. initial, intermediate and final assessments will be performed with our self-developed physioanalyst software using visual feedback tools. the video exercises given to the participants will include williams, mckenzie exercises and core strengthening exercises. visual analogue scale pain score, nottingham health profile, pain catastrophising scale, oswestry disability index, telehealth usability questionnaire, telemedicine satisfaction questionnaire, exercise adherence rating scale will be applied.

Eligibility criteria:
inclusion criteria: * individuals with low back pain for more than 3 months and diagnosed with chronic low back pain * adult patients aged between 18 and 65 years * individuals without a radicular symptom * patients who can understand and respond to verbal commands and who do not have hearing or speech problems or psychiatric problems that may prevent communication * patients who have devices with sufficient requirements to receive the exercise programme and assessments offered by telerehabilitation exclusion criteria: * spinal surgery history * presence of malignancy * presence of other orthopaedic and/or neurological diseases that may affect the assessment and treatment * pregnant women or women with suspected pregnancy * patients who did not sign the consent form required for participation in the study
the effect of baby-led weaning and traditional complementary feeding education on infant development

Conditions: Growth; Infant Development; Complementary Feeding; Nutrition, Healthy; Anemia, Iron Deficiency; Obesity, Infant

Summary: the goal of this \[type of study: clinical trial\] is to compare compare the nutrition, development, obesity risk and anemia risk of the infant with the blw method and tcf method given to the mothers of infants who have switched to complementary feeding. the main question\[s\] it aims to answer are: * does the training on the gtb and blw method given in accordance with the developmental age of the baby in months have an effect on the feeding and development of the babies in both groups? * does the training on the gtb and blw method given in accordance with the developmental age of the baby in months have an effect on the obesity risk and anemia risk of babies in both groups? participants will participate in each session of the complementary nutrition trainings given in accordance with their age on a monthly basis and will provide a diet suitable for the trainings. researchers will compare the nutritional parameters, developmental levels, and height and weight gains of infants fed with the blw and tcf method to see the effect of complementary feeding education on the nutrition and development of infants and whether there is anemia and obesity risk.

regarding the basic questions that the study aims to answer; micronutrient intake, hemoglobin, ferritin and vitamin b12 levels were evaluated to examine the effects of the trainings on infant nutrition. physical, cognitive, psychosocial, language, motor and game development levels of infants were evaluated in order to examine the effects of training on infant development. weight gain, wlz, laz and waz scores of infants were evaluated to examine the effects of the education given on obesity risk. hemoglobin, hematocrit and ferritin levels were evaluated to examine the effects of the training given on the risk of anemia.

Eligibility criteria:
inclusion criteria: for mothers; * the fact that the mothers came to the center where the research will be conducted for routine baby follow-up and vaccination follow-up. * mothers' willingness to participate in the research * absence of any communication problems * the mothers must be at least 19 years old. * mothers have no physical or mental disability for babies; . babies must be at least 4 months and maximum 6 months old when they are included in the study. * complementary feeding not yet started * babies being fed only with breast milk * babies not born before 38 weeks of gestation * absence of a congenital anomaly * absence of any digestive and neurological system diseases that may affect nutrition exclusion criteria: * infants and mothers who did not meet the inclusion criteria were not included in the study.

Keywords: growth infant development complementary feeding nutrition, healthy anemia, iron deficiency obesity, infant solid food
brachial plexus block in post-op pain control after distal upper extremity fracture: a prospective randomized study

Conditions: Pain

Summary: despite the plethora of literature suggesting that regional blockade provides adequate andimproved postoperative pain control, function and improved intraoperative and postoperative safety in proximal upper extremity surgery, little is known of its benefits for the treatment of forearm and distal radius fractures . the purpose of this randomized, prospective, study is to determine if brachial plexus blockade with general anesthesia is superior to general anesthesia alone in immediate and long-term pain control in patients undergoing operative fixation of distal upper extremity fractures.

the purpose of this study is to compare two (2) different types of anesthesia treatments that are used during surgery for broken arms for post-surgery pain relief. one group will receive general anesthesia (state of total unconsciousness) the other group will get sedation (medicine injected into patient's vein that helps patient fall asleep), and a nerve block (injection of anesthetic drug into the nerves going to patient's arm in order to make patient's arm numb). both forms of anesthesia are used for a variety of surgeries to the arm including shoulder and elbow surgeries. currently it is thought that there are advantages and disadvantages to both types. the advantage of not using the nerve block in addition to general anesthesia (current standard or care) is that it decreases the potential risk for bleeding, infection and nerve injury. alternatively, the advantage of using the nerve block with sedation (research-related procedure) is that it can potentially offer better post-operative pain control. this study will examine whether there is added benefit with the addition of nerve block for anesthesia for decreasing pain after surgical treatment of lower arm fractures.

Eligibility criteria:
inclusion criteria: 1. patients at least 18 years old. 2. male or female 3. all racial and ethnic groups 4. fractures and fracture/dislocations of the elbow, forearm, wrist and hand 5. montaggia and galleazzi variants 6. patients who opt for surgical treatment of their fractures. 7. patients who consent to be randomized. 8. patients who are willing to follow-up for a minimum of 52 weeks. exclusion criteria: 1. patients younger than 18 years old. 2. patients who are unwilling to follow-up for a minimum of 52 weeks. 3. limitation in upper extremity function that would affect outcome scoring 4. neurologic condition that could interfere with pain sensation 5. patients with a contraindication to one of the anesthesia protocols 6. patients who refuse a specific anesthesia protocol

Keywords: pain
photobiomodulation therapy on low back pain

Conditions: Low Back Pain

Summary: photobiomodulation therapy (pbmt) is a non-pharmacological method commonly used in treatment of musculoskeletal disorders. however, there are few high-quality scientific evidence to support the effectiveness of this therapy in the treatment of patients with chronic low back pain, at short, medium and long term. the present research project aims to evaluate the effects of pbmt in patients with chronic non-specific low back pain.

this is a randomized, triple-blinded, placebo-controlled trial, with voluntary patients with chronic non-specific low back pain.one hundred and forty-eight patients will be randomly allocated to two treatment groups: placebo or pbmt for 4 weeks (3 times per week, total of 12 sessions of 27 minutes each). the clinical outcomes will be obtained at the completion of treatment (4 weeks) and at 3, 6 and 12 months after randomization. the data will be collected by a blinded assessor. the statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by using mixed linear models. the outcomes of interest are pain intensity, disability, function and global perceived effect.

Eligibility criteria:
inclusion criteria: * patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month); * with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale; * aged between 18 and 65 years; * able to read portuguese. exclusion criteria: * evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit); * serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases); * serious cardiovascular and metabolic diseases; * previous back surgery; * pregnancy.

Keywords: low back pain, photobiomodulation therapy, lllt