Kornimate/medical-research-clean huggingface dataset:
preclinical research of mμsors for noninvasive blood glucose detection

Conditions: Type 2 Diabetes; Medical Device

Summary: this is a single-center, open-label, prospective study. blood glucose was measured at different time points during oral glucose tolerance testing in patients with type 2 diabetes mellitus, using both venous plasma and multi-channel microspatial offset raman scattering spectroscopy (mμsors). venous plasma glucose was set as gold standard.the two measurements were collected synchronously so as to calculate the mean absolute relative difference (mard) and the consensus error grid (ceg). accuracy of non-invasive blood glucose testing by mμsors will be validated. mard for two measurement methods in different blood glucose ranges and the safety outcomes of mμsors such as adverse events will also be assessed.

in order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμsors technology, and to explore the feasibility of non-invasive detection in multi-indicators of mμsors, this study will conduct an oral glucose tolerance test on patients with type 2 diabetes. there will be 12 collection points of blood samples as follows: 0-min and post glucose-load 15-min，30-min，45-min，60-min，75-min，90-min，105-min，120-min，135-min，150-min， and 180-min. approximately 4ml of whole blood was collected at each time point for venous plasma glucose and serum insulin measurement. the blood glucose value measured by mμsors will be obtained synchronously at the above 12 time points.

Eligibility criteria:
inclusion criteria: * 1. subjects with type 2 diabetes mellitus; * 2. age ≥ 18 years; * 3. there are no scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested; * 4. fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form. exclusion criteria: * 1. type 1 diabetes, monogenic diabetes, pancreatic damage, or secondary diabetes of other causes should be excluded; * 2. severe structural heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (nyha≥iii); acute myocardial infarction within 12 months before enrollment; history of severe liver or kidney dysfunction(mdrd egfr\< 60 ml/min/1.73m2); and mental disorders, etc.; * 3. with a history of acute complications of diabetes within 3 months before enrollment; or severe chronic complications of diabetes; * 4. alcohol dependency or drug abuse; * 5. those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial); * 6. pregnancy or lactation period; * 7. difficulty in venous blood collection or blood-injection-injury phobia; * 8. other circumstances that the investigator considers inappropriate to participate in the study.
comparison of functional outcomes of ejaculation-preserving partial trans urethral resection of the prostate with complete trans urethral resection of the prostate for benign prostatic obstruction

Conditions: Benign Prostatic Hyperplasia

Summary: it has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (qol). ejaculatory dysfunction (ejd) is the most common side effect of surgical treatment of benign prostatic obstruction (bpo). it has been considered for decades to be an inevitable consequence of restoring micturition comfort. ejd can have a substantial deleterious effect on the qol of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. a better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.

the aim of this study is to compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. the secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, global sexual life, urinary flow, complication related to the surgery and the rates of re-treatment. investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (conventional endoscopic prostatic surgery vs partial surgery preserving the prostatic apex.

Eligibility criteria:
inclusion criteria: * man over 40 years old * indication of surgical management for bph * prostate volume ≥30 cc and ≤150 cc as evaluated by ultrasonography ( or an mri if available) * ipss score ≥12 * qmax ≤15 ml/s * affiliated to french national social security system * wish and be able to comply with planned visits * able to express his consent * signed informed consent form exclusion criteria: * unwillingness to accept the treatment * no pre-operative ejaculation or sexuality * neurological pathology responsible for micturition disorders * history of prostatic surgery * stenosis of the urethra symptomatic * history of prostate cancer * history of radiotherapy or pelvic surgery * patient refusing the principle of partial surgery * life expectancy \<3 years * inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks. * participation in another clinical study involving an investigational product within 1 month before study entry.

Keywords: lower urinary tract symptoms transurethral resection of prostate partial transurethral resection of prostate quality of life ejaculation
innovative approaches to gauge progression of sturge-weber syndrome

Conditions: Sturge-Weber Syndrome

Summary: this study has three aims that hope to expand the knowledge on the cause of sturge-weber syndrome (sws) and improve clinical care of sturge-weber syndrome patients.

this study is one of three projects of an nih rare disease clinical research consortium focused on brain blood vessel malformations in three different rare diseases. the focus of this project is on sturge-weber syndrome. we plan to improve the future understanding and treatment of sturge-weber syndrome by 1) establishing a national consortium database which will gather lager amounts of clinical data and serve indirectly as a registry to foster future clinical trials and determine the usefulness of urine vascular biomarkers to determine the vascular remodeling of the sws birthmark and choroidal angioma, 2) study vascular remodeling with retrospective and prospective neuroimaging to determine the vascular remodeling of the deep draining intraparenchymal vessels as it relates to sws neurologic status, and 3) relate the gnaq mutation to altered phosphorylation of pathway proteins and angiogenesis factors in sws tissue.

Eligibility criteria:
inclusion criteria: for aim 1: for main sample: * sturge-weber syndrome * diagnosed brain involvement for control: * family member of participating sws patient for oct: * sturge-weber syndrome eye involvement for aim 2: * sturge-weber syndrome * diagnosed brain involvement for aim 3: * sturge-weber syndrome * diagnosed brain involvement * port-wine stain in v1 and/or v2 areas of face. exclusion criteria: * not diagnosed with sturge-weber syndrome with brain involvement (or eye involvement for oct) for aim 1: * family member must not have certain medical conditions. a list will be provided before consent is given. for aim 3: * not diagnosed with sturge-weber syndrome with brain involvement * no port-wine stain

Keywords: sturge weber syndrome biomarkers dna arrays brain vessel malformations
honey dressing - a preventive procedure for post-surgical site infection.

Conditions: Wound Infection; Wound Dehiscence; Wound Bleeding; Wound Surgical

Summary: the goal of this clinical trial is to compare the wound healing in the participants who underwent the clean surgical procedure, by applying honey dressing and common iodine solution dressing, participants will have no other co-morbidities like diabetes, anemia, etc. which can make the results biased. the main questions it aims to answer are: * do the iodine solutions are enough to counter the infections caused by resistant strains of bacteria? * what is the efficacy and efficiency of honey dressing in wound care? participants will be tasked to * ensure strict follow-up in the hospital dressing room * half of the participants will apply common iodine solution dressing and the other half will be applied honey dressing. researchers will compare iodine dressing (control group) with honey dressing (experimental group) to see if honey dressing is better in the prevention of post-surgery wound infection and if it is cost-efficient and its efficacy.


Eligibility criteria:
inclusion criteria: patients with sterile/clean post-surgical wounds are admitted in general surgery, neurosurgery, orthopedic, and gynecology wards and require follow-up dressings. exclusion criteria: 1. patients with: * anemia * bmi\>30 * local infection in wound area. * venous leg ulcers * diabetes * immunocompromised (oncological patients) 2. patient under negative pressure therapy
umbrella - incidence of arrhythmias in spanish population with a medtronic implantable cardiac defibrillator (icd) implant

Conditions: Cardiomyopathies; Cardiac Arrhythmias; Cardiac Arrest

Summary: the purpose of the study is to analyze the different patient profiles implanted with an implantable cardiac defibrillator (icd) in spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant indication, arrhythmias incidence, treatments or device programming.

umbrella is a prospective and retrospective cohort study.

Eligibility criteria:
inclusion criteria: * patients with a medtronic implantable cardiac defibrillator (icd) according to guidelines. * patients with carelink home telemonitoring system. exclusion criteria: * unwillingness or inability to sign study written informed consent and/or carelink consent.

Keywords: defibrillators, implantable cardiac arrhythmias heart disease
phase i/ii clinical study of fh-006 for injection in patients with malignant solid tumors

Conditions: Malignant Solid Tumor

Summary: evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of fh-006 in subjects with advanced malignant solid tumors, and determine the maximum tolerated dose (mtd) or maximum administered dose (mad), recommended dose for phase ii clinical trials (rp2d), and preliminary efficacy.


Eligibility criteria:
inclusion criteria: 1. women aged 18 to 75 (inclusive) 2. subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment. 3. ecog score is 0 or 1 4. an expected survival of ≥3 months 5. at least one target lesion according to recist v1.1 criteria 6. has a good level of organ function 7. patients voluntarily joined the study and signed informed consent exclusion criteria: 1. have other malignancies within the past 5 years 2. active central nervous system metastasis without surgery or radiotherapy 3. presence with uncontrollable third space effusion 4. have undergone other anti-tumor treatment within 4 weeks before the first dose 5. has severe infection within 4 weeks before the first medication 6. any active autoimmune disease or a history of autoimmune disease 7. a history of immune deficiency 8. has serious cardiovascular and cerebrovascular diseases 9. clinically significant history of lung disease 10. the toxicity from previous anti-tumor treatment has not recovered to ≤ grade i 11. having undergone surgery on important organs within 4 weeks prior to the first use of medication 12. used attenuated live vaccine within 28 days prior to the first use of the investigational drug 13. presence of other serious physical or mental diseases or laboratory abnormalities
evaluate the safety and exploratory efficacy of gc1119

Conditions: Fabry Disease

Summary: the purpose of this study is to evaluate the safety and exploratory efficacy of gc1119 (recombinant human α-galactosidase a) for enzyme replacement therapy in fabry disease patients.


Eligibility criteria:
inclusion criteria: * subjects with a current diagnosis of fabry's disease * plasma α-gal activity of ≤ 1.5mnol/hr/ml and have a mutation in α-galactosidase a gene * males ≥ 16 years old * subjects capable of performing this clinical trial in an appropriate manner * informed consent form voluntarily signed by the subject(or his legally acceptable representative if the subject is under 20 years old) to participation in the study * agreement to contraception during the study period exclusion criteria: * serum creatinine \> 2.5mg/dl * subjects have a plan to kidney transplantation * subjects have undergone kidney transplantation * subjects are currently on dialysis * subjects have a clinically significant organic disease(cardiovascular, hepatic, pulmonary, neurologic, or renal disease)that in the opinion of the investigator would preclude participation in the trial * known life-threatening hypersensitivity(anaphylactic reaction) to α-galactosidase * treatment with another investigational product within 30days from the administration of study drug dosing or plans to be treated with another investigational product during the study period * known hypersensitivity to any of the ingredients of study drug(including excipients) * subjects need the medication of prohibited drug * alcoholism or drug addiction
evaluation of risk factors and outcome of thrombosis in children

Conditions: Thrombosis in Children

Summary: pediatric thrombosis is multifactorial, and usually risk factors either congenital or acquired are present. patient may has one risk factor or more such as sepsis, cancers, congenital heart disease, post surgery , central venous catheter insertion, nephrotic syndrome, systemic lupus erythromatosis and inflammatory bowel disease. if there's no obvious risk factor for thrombosis, hereditary thrombophilia is suspected which results when an inherited factor, such as antithrombin , protein c or protein s deficiency.

thrombosis is the formation of a blood clot (partial or complete blockage) within blood vessels, whether venous or arterial, limiting the natural flow of blood and resulting in clinical sequela. incidence of childhood thrombosis is 0.07-0.14/10,000 in the general population. this incidence has been reported to be 5.3/10,000 in children presenting to hospital, 0.51/10,000 in all newborns and 0.24/10,000 in children in neonatal intensive care units . pediatric thrombosis is multifactorial, and usually risk factors either congenital or acquired are present. . patient may has one risk factor or more such as sepsis, cancers, congenital heart disease, post surgery , central venous catheter insertion, nephrotic syndrome, systemic lupus erythromatosis and inflammatory bowel disease. if there's no obvious risk factor for thrombosis, hereditary thrombophilia is suspected which results when an inherited factor, such as antithrombin , protein c or protein s deficiency. there are three changes described by virchow in 1856 are involved in the formation of thrombosis: 1. changes in blood flow (rheology, stasis) 2. changes in the vascular wall 3. changes in the blood levels of coagulation factors the diagnosis of thrombosis is made more frequently and more easily in children due to noninvasive diagnos-tic methods \[doppler and ultrasonography (us), echo-cardiography, computed tomography (ct) and magnet-ic resonance imaging (mri)\]. the morbidity and mortality rates are high, although it occurs more rarely compared with adult thrombosis and does not develop in the absence of a triggering factor; the rate of mortality related with direct venous thromboembolism is 2.2%, the frequency of post-thrombotic syndrome is 12.4%, and the recurrence rate for thrombosis is 8.1%.

Eligibility criteria:
inclusion criteria:• all children age from one day to 18 yrs presented with any vascular thrombosis decomented by clinical picture and venous doppler study or radiological study. - exclusion criteria: * • persons above 18 years old.
qualitative survey of potential exercise activity in adults with sickle cell anemia (sca)

Conditions: Cardiovascular Diseases; Sickle Cell Disease; Exercise

Summary: the purpose of this study is to assess the potential interventions of exercises in adults with sickle cell anemia (sca) and cardiopulmonary disease; only including the more severe genotypes of sickle cell disease.

sickle cell disease is an inherited blood disorder that affects approximately 100,000 people in the united states. people living with sickle cell disease have numerous complications that cause significant morbidity and mortality such as painful episodes of vasoocclusion, acute chest syndrome, stroke, end organ damage, and early death. unfortunately, their lifespan remains markedly shorter than the general population and this had not dramatically changed in the last 2 decades. adults, are now not dying primarily from infections and sickle cell disease related complications, but cardiopulmonary disease is a leading cause of death. the etiology of cardiopulmonary disease in sickle cell disease is unclear but studies suggest that microvascular hypoxia, inflammation and endothelial dysfunction play a major role in the pathogenesis. in the general population, exercise reduces cardiovascular complications, pulmonary exacerbations, and decreases cardiovascular death. however, exercise used as primary or secondary prevention in sickle cell disease for cardiopulmonary disease has not been explored. evidence shows that exercise in sickle cell disease can decrease oxidative stress, lower blood viscosity, and increase nitric oxide levels in both human and mouse models, but there remains some concern that high-intensity training in sickle cell disease may trigger vaso-occlusive crisis and adverse outcomes. however, multiple recent studies show that moderate intensity exercise can be safely performed in adults with sickle cell disease. currently, providers lack evidence-based knowledge to inform the quantity and quality of regular exercise training that is safe but also improves cardiovascular outcomes in sickle cell disease. in addition, data does not exist on the feasibility and adherence of home-based training regimens in adults with sickle cell disease. only one study has explored the feasibility and adherence in children. this study will be a qualitative assessment of potential interventions of exercises in adults with sickle cell anemia, only including the more severe genotypes of sickle cell disease.

Eligibility criteria:
inclusion criteria: * 18 years or older with a known diagnosis of sickle cell anemia * subject (and, parental/legal representative, when applicable) must understand and voluntarily sign a consent form and complete an interview exclusion criteria: - subjects who does not meet the inclusion criteria above
preoperative percutaneous radiofrequency ablation of primary and secondary lung tumors

Conditions: Lung Cancer; Lung Metastasis

Summary: the purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

thermal ablation therapy is an increasingly performed technique in the local tumor treatment. among these techniques, image-guided radiofrequency (rf) ablation attained widespread consideration in the therapy of liver tumors and osteoid osteoma. promising results of hepatic rf ablation raised expectations to utilize the advantages of image-guided ablation therapy for the treatment of pulmonary malignancies. the purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors. computed tomography-guided rf ablation is performed in local or general anesthesia, followed by surgical resection three days later. an analysis of complete rf ablation and a characterization of tissue response is performed by hematoxylin and eosin staining, immunostaining, and electron microscopy. adverse effects and complications are recorded.

Eligibility criteria:
inclusion criteria: * signed informed consent for radiofrequency ablation and surgery * maximum of 3 lung tumors * maximum tumor size 5 cm * must be able to receive standard surgery exclusion criteria: * pathological coagulation tests * pregnant or breast feeding * maximum tumor size more than 5 cm * bilateral secondary lung cancer with more than 3 tumors * inoperable patient

Keywords: lung cancer lung metastasis radiofrequency ablation
"core stabilization strenght and pelvic floor functions in primary sjogren's"

Conditions: Sjogren Syndrome; Healthy Volunteers

Summary: this study aims to explain the comparison of core stabilization strength and pelvic floor functions between individuals diagnosed with sjogren syndrome and a healthy control group. (sjogren syndrome group n=27; control group n=27)


Eligibility criteria:
inclusion criteria: sjogren syndrome group: * diagnosed by a rheumatologist * being 18 years of age or older, * agreeing to participate in the study control group: -being 18 years of age or older, exclusion criteria: sjogren syndrome group and control group: * presence of neurological disease * presence of any orthopedic problem that would affect functionality * presence of a history of orthopedic surgery

Keywords: pelvic floor core stabilization sjogren syndrome