Kornimate/medical-research-clean huggingface dataset:
the peripheral mobilized mononuclear cell-based therapy in patient with diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: to investigate the efficacy and safety of autologous peripheral blood stem cell based therapy in patients with diabetic painful neuropathy.

diabetic painful neuropathy a prevalent, disabling disorder. currently, the only effective treatments are glucose control and pain management. diabetic neuropathy is characterized by reduction of vascularity in peripheral nerves and deficiency in neurotrophic and angiogenic factors. recent studies have shown that bone marrow (bm)-derived stem or progenitor cells have favorable effects on the repair of cardiovascular diseases. since these bm-derived stem or progenitor cells contain various angiogenic and neurotrophic factors, these cells have been attempted for treating experimental diabetic neuropathy, and turned out to be effective for reversing various manifestations of experimental diabetic neuropathy. however, stem-cell therapy was not proven in human study. therefore, we will investigate the efficacy and safety of autologous peripheral blood stem cell injection in diabetic neuropathy.

Eligibility criteria:
inclusion criteria: * symptomatic diabetic neuropathy moderate pain more than 3 months michigan neuropathy screening instrument (mnsi) \>3 3/day mean pain scale \> nrs 4 body weight \>50 kg systolic blood pressure: 90-150 mmhg, diastolic blood pressure \<100 mmhg, body temperature \<37.5℃, pulse rate: 50-100/min exclusion criteria: * other cause of neuropathy symptomatic peripheral vessel disease skin lesion or arthritis central neuronal disease drug addiction or abuse aspartate aminotransferase or alanine aminotransferase \>1.5 times than upper normal limit range creatinine clearance rate \<60ml/min or dialysis myocardial infarction, unstable angina or heart failure diagnosed in 3 months psychologic disorder pregnancy or lactation
mr spectroscopy and disease severity score for gaucher in pediatric population

Conditions: Gaucher

Summary: the bone status in gaucher disease is very difficult to monitor precisely in children. this is a major problem because lack of optimal treatment, especially enzyme replacement, may cause irreversible severe bone damage that will impact an affected person's life. currently, there are qualitative (subjective) methods, such as magnetic resonance imaging (mri), to gauge the response to treatment. a quantitative (objective) measurement of gaucher cell presence and activity in bone marrow could help with more precise and accurate monitoring of bone marrow disease in patients both treated and not (yet) being treated with enzyme replacement. the investigators will evaluate the efficacy of magnetic resonance spectroscopy (mrs) as a quantitative assessment of bone marrow involvement in children with gaucher, and examine how this result correlates with semiquantitative mri scales and overall disease severity.

to quantify the amount of fat in the bone marrow of affected subjects and healthy controls the investigators will use single voxel short, echo time(te) proton spectroscopy. this mr spectroscopy (mrs) will be conducted in the vertebral body of l5 and in the neck of the femur. to assess the qualitative scores and compare it to the quantitative mr spectroscopy (mrs) results the investigators will use a series of fluid sensitive and fat sensitive conventional mr sequences that will allows us to determine indirectly the degree of glucocerebrosidase infiltration.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of gaucher disease / age and gender match control * children aged 5-20 yrs * parental consent * child assent if appropriate exclusion criteria: * presence of medical illness or exposure to drugs that alter the appearance of bone marrow on mri * contraindication for mri * likelihood for claustrophobia * non cooperative patient * pregnancy

Keywords: lysosomal diseases magnetic resonance spectroscopy mri
assessing uterine ultrasound done as a diagnostic tool for the depth of carcinoma invasion

Conditions: Endometrial Endometroid Carcinoma

Summary: in this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). the investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.


Eligibility criteria:
inclusion criteria: 1. patient's age is 18 or above 2. patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms. 3. patient able to understand,read and sign informed consent. 4. patient is not participating in other medical trials at present or in the past 30 days exclusion criteria: 1. age under 18 years 2. patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma 3. subjects which their biopsy in the pre operating process will include high risk cell types: * grade 3 endometrioid adenocarcinoma, * clear cell carcinoma * papillary serous carcinoma * carcinosarcoma
opposite si joint stretching for gird

Conditions: Shoulder Impingement

Summary: the purpose of this study is to investigate if stretching the contralateral sacroiliac (si) joint improves gird in baseball players. additionally, we aimed to compare our si joint stretching regiment with a classically described sleeper stretch routine.

abstract: background: glenohumeral internal rotational deficit (gird) is a well-documented finding in throwing athletes. hypothesis/purpose: the purpose of this study is to investigate if stretching the contralateral sacroiliac (si) joint improves gird in baseball players. additionally, the effect of the si joint stretch will be compared to that of the classically described sleeper stretch. study design: randomized controlled clinical trial methods: with the athlete supine and arm abducted 90o, internal rotation of both shoulders was measured in 23 minor league baseball players. next, each player randomly was assigned to either a control (sleeper stretch of dominant shoulder) or experimental (stretch of the si joint contralateral to the dominant shoulder) group supervised by a certified athletic trainer. the players performed their own stretches. finally, the initial two investigators, unaware of to which group the player was assigned, re-measured the end-range internal rotation of each athlete's dominant shoulder.

Eligibility criteria:
inclusion criteria: * all members a minor league baseball team exclusion criteria: * any active shoulder or back injury or history of shoulder or back injury

Keywords: glenohumeral internal rotational deficit gird sleeper stretch si joint stretch
correlation between change of hba1c, urinary glucose excretion and other factors in patients treated with ipragliflozin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to examine the correlation between change of hba1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subject who has written informed consent * subjects who are diagnosed as type 2 diabetes mellitus * subjects who are 20 to 70 years old * subjects on a stable diet and exercise at least 8 weeks prior to the study participation * stable doses of the following medications for 8 weeks or more but, hba1c level of 7.0 to 9.5% (metformin, metformin + su, metformin + dpp-4 inhibitor, metformin + tzd, tzd, tzd + su, tzd + dpp-4 inhibitor, su, su + dpp-4 inhibitor, dpp-4 inhibitor) exclusion criteria: * type 1 dm * gestational dm * diabetic ketoacidosis * ckd stage 3b-5 (egfr 45) * severe infection, serious trauma, or perioperative period * known or suspected hypersensitivity to ipragliflozin * symptomatic urogenital infection * chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer) * under the therapeutic intervention and/or another clinical study using ip drug * hepatic disease ( 3 times of upper normal limit of ast or alt) * serious voiding difficulty due to neurogenic bladder or prostate hyperplasia * drugs not allowed for concomitant use * alpha glucosidase inhibitor or meglitinide within 60 days prior to screening * insulin within 60 days prior to screening * systemic steroid use (po, iv or im) over 2 weeks within 3 months prior to screening * inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate * glp-1 agonist (except for exenatide) within 60 days prior to screening * heart failure (nyha class iii-iv) or uncontrolled arrhythmia within 6 months prior to screening * cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening * subjects who are not eligible to the study according to an investigator's decision * inability to read the consent form * pregnancy, lactation, or plan to get pregnant during the study period
biomarker identification and nutritional intervention of primary sarcopenia based on gut-muscle axis

Conditions: Sarcopenia

Summary: the loss of skeletal muscle mass and function usually occurs with aging, known as primary sarcopenia. sarcopenia has a prevalence of 11.6% among the elderly population in china and is closely associated with increased risks of falls, disability, and mortality. currently, there is a lack of definition criteria for sarcopenia based on biomarkers. the gut-muscle axis hypothesis suggests a complex interplay between gut microbiota and skeletal muscle. nutritional intervention targeting the gut microbiota potentially plays a significant role in muscle regeneration. therefore, this study aims to explore the effects of symbiotic and whey protein on muscle, gut microbiota, and clinical outcomes among sarcopenia patients, to provide a reference for further diagnosis and treatment of sarcopenia.

this study will last 12 weeks. for the duration of the study, an anticipated total of 120 participants will be randomly assigned to three groups. during the study visits, questionnaires, blood and stool collection, and functional testing will occur. intention-to-treat analysis (itt) and per-protocol analysis (pp) will be conducted in statistical analysis.

Eligibility criteria:
inclusion criteria: 1. age 65 and older 2. can cooperate with the measurement and questionnaire survey 3. meets asian working group for sarcopenia (awgs) 2019 diagnostic criteria for sarcopenia 4. obtain informed consent to participate in this study exclusion criteria: 1. severe complications 2. suffers from neuromuscular related diseases 3. immobility 4. have taken antibiotics, probiotics and other medications that may affect the gut microbiota in the last 6 weeks 5. implants of electronic devices or metal objects in the body

Keywords: sarcopenia gut-muscle axis biomarker gut microbiota intervention
perioperative parameter and treatment outcomes of surgical treatment for benign prostate hyperplasia in hong kong

Conditions: Benign Prostatic Hyperplasia

Summary: this is a prospective data registry to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters.

benign prostatic hyperplasia (bph) is a very common disease affecting men. patients with bph may present with voiding symptoms including hesitancy, intermittence, slow stream and sensation of incomplete emptying, and storage symptoms including urinary frequency, urgency and nocturia. patients may also suffer from complications including urinary retention, recurrent urinary tract infection, bladder stone formation and obstructive uropathy. for patients who have lower urinary tract symptoms refractory to medications, or those who suffer from complications of bph, transurethral prostatectomy should be considered. surgical intervention options have evolved from electrosurgical resection to the use of lasers for enucleation and ablation \[1\]. aquablation and rezum system are new minimally invasive surgical technology for bph management. \[2,3,4\]. different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. however, large-scale studies investigating the different modalities of surgical treatment of bph are lacking. therefore, a prospective data registry is created to assess the perioperative surgical outcomes for different surgical treatment of bph.

Eligibility criteria:
inclusion criteria: * patient at the age of 18 or above exclusion criteria: * patient is unable to give consent
human bone graft for fixation of osteochondral defects in the knee joint

Conditions: Osteochondral Defect

Summary: this observational study is to document the application of a human bone graft in the surgical repair of bone fragment detachment in the knee joint (osteochondral defect) and its subsequent healing process.

for the treatment of bone fractures metal screws have been used for decades. removal of material is the major disadvantage of conventional osteosynthesis and requires a second intervention, with all the complications and risks for each patient. in order to avoid this second surgery, it is possible to use human bone screw grafts instead of metal screws. the bone graft helps to create a solid, bony connection. this connection leads to an extension, a bone remodeling, bone installation and optimal reparation process in the affected area. the comparatively rare occurrence of suitable patients contributes to the fact that there has not been enough systematic research to objectively confirm the benefits of the product, which is why this observational study is being conducted. in total, 20 patients will be enrolled in several centers in austria. the low number of cases and the multicenter design is due to the rarity of suitable patients. this observational study will use shark screw® grafts without exception at all participating centers. these grafts are manufactured by two tissue banks, the austrian tissue bank surgebright and the german institute for cell and tissue replacement (dzig) and were approved by the competent austrian authority (ages) in 2016. all patients participating in this observational study, due to a medical indication, undergo surgical treatment of osteochondral defects using the bone screws mentioned above. postoperatively, the patients are observed over a period of 24 months. in total, there are five follow-up examinations during which clinical examinations, x-rays and a magnetic resonance tomography (mri) is performed. in addition the kos-adl and ikdc score are collected.

Eligibility criteria:
inclusion criteria: * indication for the use of a human bone graft in the surgical treatment of osteochondral defects * legal capability of adults, guardians and adolescents aged 14 to 17 years, age-appropriate perceptivity for children 8 to 13 years old * written consent to participation in the study after previous written and oral education (additional consent for participation of minors in the study after prior written and oral education by at least one parent) * age ≥ 8 years exclusion criteria: * insufficient knowledge of the german language * alcohol and drug abuse * pregnant or breastfeeding woman * foreseeable compliance issues * neoplastic diseases, malignant bone tumors, rheumatoid arthritis * active osteomyelitis * ulcerations in the area of the skin of the surgical area * immunosuppressive drugs that can not be discontinued

Keywords: human bone graft screw osteochondral defect knee
a randomized controlled trial of electrical stimulation to treat pelvic floor disorder

Conditions: Pelvic Organ Prolapse; Incontinence

Summary: female pelvic floor disorders (pfds) include urinary incontinence,pelvic organ prolapse (pop), and fecal incontinence-which often occur together. pelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women. surgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies. this may be because of higher awareness among women and cost of and morbidity after surgery. the conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback. the outcome was up to 35\~70 % improved rate as the literature before. current guidelines recommended conservative management as a first-line therapy. however, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies. therefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for pelvic floor disorder (pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.). at the aspect of quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.


Eligibility criteria:
inclusion criteria: * patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence. exclusion criteria: * patient is pregnant the patient had any major medical or psychiatric disease the patient with metabolic medical device

Keywords: electrical stimulation biofeedback
study to evaluate the effects of at-527 in non-hospitalized adult patients with mild or moderate covid-19

Conditions: COVID-19

Summary: this randomized study evaluates the antiviral activity, safety, efficacy and pharmacokinetics of at-527 versus a placebo in participants with mild or moderate coronavirus disease (covid-19) who are not hospitalized.


Eligibility criteria:
inclusion criteria: * positive sars-cov-2 diagnostic test (rt-pcr or rapid antigen test)at screening * has symptoms consistent with mild or moderate covid-19, as determined by the investigator, with onset ≤5 days prior to randomization exclusion criteria: * clinical signs indicative of covid-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air * treatment with a therapeutic agent against sars-cov-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against sars cov-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening * requirement, in the opinion of the investigator, for any of the prohibited medications during the study * use of hydroxychloroquine or amiodarone within 3 months of screening * pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of at-527. women of childbearing potential must have a negative urine pregnancy test result at screening * abnormal laboratory test results at screening * clinically significant abnormal ecg, as determined by the investigator, at screening * planned procedure or surgery during the study * known allergy or hypersensitivity to study drug or drug product excipients * substance abuse, as determined by the investigator, within 12 months prior to screening * poor peripheral venous access * malabsorption syndrome or other condition that would interfere with enteral absorption * any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion * history of anaphylaxis * any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
the role of sacubitril/valsartan in post-acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: sacubitril/valsartan (sac/val) is a new treatment of congestive heart failure (chf) recently indicated as class i, level of evidence b in the recent european society of cardiology (esc) guidelines 2016 of chf. paradigm-hf trial demonstrated a significant improvement of morbidity and mortality with sac/val in comparison to enalapril. so far, no data available about the effect of usage of sac/val post-acute myocardial infarction (ami) except in animal experimental models. the purpose of the research is evaluation of the effects of sac/val in post-ami in comparison to the traditional angiotensin converting enzyme inhibitors (aces inhibitors) or angiotensin ii receptor blockers (arbs) in a real-life clinical trial in treatment of post-ami patients with reduced left ventricular (lv) systolic function.

background and study rationale: sacubitril/valsartan (sac/val) is now approved by the u.s. food and drug administration (fda) for heart failure with reduced ejection fraction (hfref) and also, recently indicated as class i indication, level of evidence b in the european society of cardiology (esc) guidelines 2016 on congestive heart failure (chf).(1) paradigm-hf trial demonstrated that morbidity and mortality can be improved with sac/val in comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalization for chf by 20% with a 16% reduction in all-cause mortality.(2) so far, no available data about the effect of usage of sac/val in post-ami except in animal experimental models that proved efficacy of sac/val in preventing ami-induced lv dysfunction compared with sac/val, also significantly attenuated lv scar size following ami compared with placebo .(3) aim of the work: * this study aims to investigate the effects of sac/val in post-ami through using it instead of conventional angiotensin converting enzyme inhibitors (aces inhibitors) or angiotensin ii receptor blockers (arbs) in treatment of post-ami patients with reduced left ventricular (lv) systolic function. * design: randomized open label interventional clinical trial.

Eligibility criteria:
inclusion criteria: * post-ami patients who underwent successful ppci and lvef ≤40%. exclusion criteria: * post-ami patients who underwent successful ppci and lvef \>40%. * history of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs. * symptomatic hypotension and/or an sbp \< 100 mmhg. * estimated gfr \ 5.2 mmol/l.