Kornimate/medical-research-clean huggingface dataset:
a feasibility study to assess critical aspects of fluorescence affinity sensor (fas) performance and safety over several hours

Conditions: Diabetes

Summary: the goal of this clinical research study is to learn about a new minimally invasive glucose monitoring device called fluorescence affinity sensor (fas). in this study, the fas will be used to determine its effectiveness for glucose monitoring. researchers want to find out how the device performs at two different body sites (forearm and abdomen) over 4 hours. the safety and comfort level of the device will also be studied.

the fas glucose monitoring system is a minimally invasive glucose monitoring device which is not yet approved by the fda. the fas system will be used in this study to monitor glucose levels during a glucose tolerance test (gtt) performed in dr.orzeck practice. the fas measures glucose levels in skin tissue of the forearm or the abdomen at a depth of less than 1 mm by inserting a small needle-like device. during the 4-hour gtt, the needle-like fas is left in the skin tissue. the fas performance has indicated in prior experiments that it is more stable than competitive commercial glucose-sensing devices. due to its unique design, its glucose response is more accurate, and less affected by certain drugs (such as pain medicine).

Eligibility criteria:
inclusion criteria: * female and male patients with type i and ii diabetes requiring injectable insulin from age 18-80. exclusion criteria: * patients with fasting glucose concentration larger than 200 mg/dl will be excluded from the study. * children under the age of 18 will not be included because texas state law would not allow such participants to give informed consent on their own. * patients who are required to take certain medications including corticosteroids, diuretics, anticonvulsants, birth-control pills, non-steroidal anti-inflammatory drugs (nsaids) and certain high-blood pressure medications will be excluded from the study. * pregnant women or any patient who cannot participate in an oral glucose tolerance test will also be excluded from the study. presence of pacemaker or defibrillator.

Keywords: subcutaneous glucose monitoring diabetes fluorescence affinity biosensor type i diabetes type ii diabetes
safety and efficacy of different dose levels of pasireotide in patients with de novo, persistent or recurrent cushing's disease

Conditions: Cushing's Disease

Summary: this study will evaluate the safety and efficacy of two different doses of pasireotide in patients with de novo or recurrent/persistent cushing's disease.


Eligibility criteria:
inclusion criteria * 18 years or greater * confirmed diagnosis of acth-dependent cushing's disease * not considered candidate for pituitary surgery exclusion criteria * history of pituitary irradiation in the last 10 years * cushing's syndrome not caused by pituitary tumor * patients with active malignant disease (cancer) in the last 5 years * women who are pregnant or lactating other protocol-defined inclusion/exclusion criteria apply.

Keywords: cushing's disease pasireotide som230
effect of intake of whey protein in elderly osteopenic patients. implications for metabolism and physical function.

Conditions: Osteopenia

Summary: the aim of this study is to investigate potential metabolic effects of whey protein high in protein and high in leucine(hphl) compared to soy protein high in protein and low in leucine(hpll) in osteopenic patients in a randomized controlled intervention study. the investigator hypothesize that hphl will increase physical function and the ratio muscle mass / fat mass in this condition.

with an increase in the older population in denmark and most other countries there is an increase in the rate of patients with age related bone and muscle weakness. proteins with a high content in ketogenic amino acids e.g. leucine have been investigated in relation to these conditions. generally acute studies in animals and some in human have been conducted and have demonstrated positive effects in relation to prevention and treatment of bone and muscle weakness. we want to investigate these tendencies with supplementation of proteins in a randomized, blinded, 4 month intervention study with three arms - 1) the control group. 2) soy protein(high protein, low leucine). 3) whey protein(high protein, high leucine). to increase any possible effect of the supplementation the subjects will complete a resistance training program concurrently. the study will focus on the anabolic properties of the ketogenic amino acids in animal whey protein compared to vegetable soy protein. the investigator will study changes in: * gait speed related to muscle strength * walk distance in a six-minute walk test related to sub maximal physical capacity * body composition (lbm/fm ratio) by a dexa-scanner * biochemical markers on bone metabolism * bone-mineral-density(bmd) and -content(bmc)(dexa scans) * muscle strength * body balance * protein and amino acid balance * nitrogen balance * gene-expression in muscle tissue * biochemical markers on fat- sugar- and protein-metabolism * biochemical markers on inflammation * blood pressure * insulin sensitivity by homa index * estimated maximal physical capacity by a bicycle ergometer test. the perspective in this study is to develop a nutritional supplement with a high content of ketogenic amino acids (e.g. leucine) that can be useful and beneficial in treatment and prevention of patients with bone and muscle weakness.

Eligibility criteria:
inclusion criteria: * osteopenia defined as bmd t-score \<-1 exclusion criteria: * vitamin d deficiency defined as 25-hydroxyvitamin d (25-oh-d) below 30 nmol/l. * liver and kidney disease. * known diabetes or hgb1c ≥6,5% (≥48mmol/l). * severe heart disease (nyha-class \>2). * oral corticosteroid treatment within the last 3 month. * anamnestic information of hip fracture or vertebral fracture. * any antiosteoporotic treatment. * participation in other intervention studies within the last 4 weeks.

Keywords: osteopenia sarcopenia osteoporosis physical function body composition muscle protein leucine ketogenic amino acids resistance training whey protein soy protein bone turnover
tranexamic acid for acute ich growth predicted by spot sign

Conditions: Intracerebral Hemorrhage; Stroke

Summary: the purpose of this study is to determine if computed tomography angiography can predict which individuals with intracerebral hemorrhage will experience significant growth in the size of the hemorrhage. for individuals who are at high risk for hemorrhage growth, the study will compare the drug tranexamic acid to placebo to determine the effect and safety of on intracerebral hemorrhage growth

the tranexamic acid for acute ich growth predicted by spot sign (traige) is a is a multicentre, randomized, placebo-controlled, double-blind, prospective, investigator-led, clinical trial of tranexamic acid within 6 hours of intracerebral hemorrhage in patients with contrast extravasation on cta, 'the spot sign'. ich patients within 6 hours of symptom onset, with the spot sign as a biomarker for ongoing hemorrhage, and no contraindications for antifibrinolytic therapy were enrolled in traige. the patient with a spot sign will be randomized to receive either the active treatment or placebo, the patient with no spot sign will be given regular treatment as observation. the trial is anticipated to complete in 36 months from the first subject recruitment , with 240 subjects recruited. a data and safety monitoring board (dsmb) will regularly monitor safety during the study. the trial has been approved by irb(institutional review board) /ec(ethics committee) in beijing tiantan hospital, capital medical university.

Eligibility criteria:
inclusion criteria: patients presenting with an acute spontaneous hypertensive intracerebral hemorrhage 1. cta evaluation can be accomplished within 6 hours of symptom onset, with "spot sign" positive in cta original image 2. age range from 18 to 79 years 3. randomization can be finished and treatment can commence within 8 hours of symptom onset 4. informed consent has been received in accordance to local ethics committee requirements exclusion criteria: 1. ich known or suspected to be secondary to tumour, vascular malformation, aneurysm or trauma 2. infratentorial ich 3. glasgow coma scale (gcs) total score of \<8 4. ich volume \>70 ml 5. parenchymal hemorrhage with ventricle involved, blood completely fills one lateral ventricle or more than half of both lateral ventricles 6. contraindication of cta imaging (e.g. known or suspected iodine allergy or significant renal failure) 7. any history or current evidence suggestive of venous or arterial thrombotic events within the previous 6 months, including clinical, ecg, laboratory, or imaging findings. clinically silent chance findings of old ischemia are not considered exclusion. 8. planned surgery for ich 9. pregnancy or within 30 days after delivery, or during lactation 10. use of heparin, low-molecular weight heparin, or oral anticoagulation within the previous 1 week, with abnormal laboratory values 11. known allergy to tranexamic acid 12. prestroke modified mrs score of \>2

Keywords: intracerebral hemorrhage tranexamic acid spot sign
intestinal flora differences between colorectal cancer patients and healthy individuals

Conditions: Colorectal Cancer; Gut Microbiota Dysbiosis

Summary: this observational case-control study aims to compare the composition of intestinal microbiota between colorectal cancer (crc) patients and healthy individuals. fecal samples from 36 crc patients and 25 healthy controls were analyzed for bacterial abundance. results indicate significant differences in beneficial, neutral, and harmful bacterial populations between groups, with crc patients showing reduced beneficial flora (e.g., lactobacillus) and increased harmful/neutral flora (e.g., staphylococcus). further stratification by cancer stage (i-iii) revealed progressive dysbiosis with disease progression.

this observational case-control study investigates the compositional differences in intestinal microbiota between individuals diagnosed with colorectal cancer (crc) and healthy controls. the study enrolled 36 crc patients confirmed by histopathology and 25 age- and gender-matched healthy volunteers without gastrointestinal diseases or antibiotic/probiotic use within the preceding three months. fecal samples were collected from crc patients at the time of diagnosis and from healthy participants during routine health screenings. utilizing 16s rrna sequencing or quantitative pcr, the relative abundance of specific bacterial taxa (e.g., lactobacillus, bifidobacterium, staphylococcus) was quantified to assess dysbiosis patterns. additionally, the analysis stratified crc patients by clinical stage (i-iii) to explore progressive shifts in microbial communities with disease advancement. the findings aim to elucidate the role of gut microbiota in crc pathogenesis and provide insights into potential microbiome-based diagnostic or therapeutic strategies.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) with histopathologically confirmed colorectal cancer (crc group) * archived fecal sample available from time of crc diagnosis (prior to treatment) * complete clinical records including tnm staging (i-iii) for crc patients * age- and gender-matched adults without crc history (control group) * archived fecal sample available from routine health check-ups (control group) exclusion criteria: * recent antibiotic or probiotic use (within 3 months) * history of inflammatory bowel disease * incomplete medical records * for controls: history of colorectal cancer, polyps, or chronic gastrointestinal diseases * for controls: abnormal colonoscopy or fecal occult blood test within the past year

Keywords: colorectal neoplasms (mesh) gastrointestinal microbiome (mesh) dysbiosis (mesh) microbial biomarkers
continuing or discontinuing ace/arbs in patients with chronic kidney disease undergoing coronary angiography

Conditions: Contrast-induced Nephropathy; Chronic Kidney Diseases; Ischemic Heart Disease

Summary: contrast induced nephropathy (cin) is a well-known possible complication of percutaneous coronary intervention (pci) with an incidence varies from 3.3% to 14.5% in patients undergoing pci. many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ace-is prior to coronary angiography, and whether it decreases or increases the risk of cin. the importance of this study is to help find an acceptable and reliable answer for the use of ace-i/arbs prior to cardiac catheterization. this research aims to study the effect of withholding ace-is or arbs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (gfr\<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ace-i/arbs pre contrast administration.

the study design is a randomized control trial; it will be done on two groups of patients. the two groups are group a (continue ace-i/arbs) and group b (withhold ace-i/arbs). the study will be conducted at the cardiology units at an-najah national university's hospital (nnuh) in nablus, palestine. study population includes chronic kidney disease patients taking ace-i or arbs therapy and are undergoing elective coronary angiography. patients who will meet the inclusion criteria and have none of the exclusion criteria will be enrolled in the trial when the appointment of their procedure is set. they will be randomly divided into two groups; group a (continue ace-i or arbs therapy) and group b (withhold ace-i or arbs therapy)using block randomization, each block consists of four participants. patients in the continuation group will take their regular ace-i/arbs on the day of the angiogram. patients in the discontinuation group will be withheld from their acei or arbs 24 h before cardiac catheterization.

Eligibility criteria:
inclusion criteria: 1. at least one month of continuous therapy with an acei or an arbs and 2. undergoing elective coronary angiography and 3. have ckd stage3-4 (15≤gfr\<60 ml/min/1.73 m2). exclusion criteria: 1. acute stemi within 2 weeks 2. nyha class iv heart failure by history 3. administration of contrast load within the previous 6 days 4. acute renal failure (arf) preceding coronary angiography 5. potassium level more than 5.0 meq/l 6. gfr \<15 ml/min/1.73 m2 7. previous percutaneous cardiac catheterization within one month 8. acute pulmonary edema 9. hemodynamically instability 10. uncontrolled hypertension 11. combination acei and arb therapy 12. cardiogenic shock 13. sepsis 14. pregnancy 15. age below 18 year

Keywords: cardiac catherization coronary angiography coronary angioplasty chronic kidney disease contrast induced nephropathy acei arbs
immediate changes after manual therapy in patients with non-specific back pain

Conditions: Back Pain

Summary: the purpose of this trial is to investigate the immediate effects of neuro-lymphatic treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.

subjects: the study was conducted at the faculty of physiotherapy of the university of valencia (spain). persistent non-specific back pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study. excluded subjects with musculoskeletal injuries such as spine or balance disorders, those which were recovering from an injury of the locomotor or neurological system, or those who had sequelae from any trauma suffered in the past six months that could affect the results of the study. study design: the conducted study was an experimental, longitudinal and prospective, controlled, randomized and single-blind design (subjects and therapists didn't know the objectives of the treatment nor how many treatments were offered, evaluators were unaware of the treatments applied). there were 3 groups: a) neuro-lymphatic treatment; b) vertebral articulatory treatment; c) proximal costal articulatory treatment.

Eligibility criteria:
inclusion criteria: * non-specific back pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study. exclusion criteria: * excluded subjects with musculoskeletal injuries such as spine or balance disorders * those which were recovering from an injury of the locomotor or neurological system, or * those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.

Keywords: back pain manual therapy
celotres for improvement in wound healing and resulting scar consequences following suturing of a wound

Conditions: Scar

Summary: the objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of celotres in a post-market setting when used to improve wound healing and the resulting scar consequences following suturing of a wound.


Eligibility criteria:
inclusion criteria: * patients electing to undergo a surgical procedure; * patients able and willing to give written informed consent exclusion criteria: * patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin
a comparison of surgical outcome following drug-induced sleep endoscopic diagnosis using propofol or dexmedetomidine for sedation : a prospective randomized trial

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea is a common disease, associated with cardiovascular disease, cerebrovascular disease, and many other medical conditions. therefore the precise diagnosis and treatment are important. with drug-induced sleep endoscopy (dise), the three-dimensional evaluation of upper airway and airway obstruction could be possible. the problem of the dise is that there is the difference between a sedative-induced sleep and normal sleep. moreover there were no standard sedation protocol of dise. propofol has short half-life, about 3 minutes, so the patients could recover quickly from it. in recent years, using target controlled infusion(tci) of propofol, the effective effect-site concentration for dise could be reached easily with hemodynamic stability and minimal toxic effect. in a previous pilot study, the endoscopy for the diagnosis of sleep apnea could be done successfully with propofol tci. however there were some desaturation events, although the eeg showed that the patient was not in deep sleep enough. therefore we thought that not only further study of propofol for dise but also the study of other drugs for dise will be needed to overcome this limitation. dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect and almost no respiratory depression, therefore it could be a good alternative drug for dise. the purpose of this study is designing the appropriate sedation protocol for dise using propofol or dexmedetomidine, and enabling the safer and more accurate dise.


Eligibility criteria:
inclusion criteria: * asa class 1, 2 * age ≥ 20 yrs * undergoing drug-induced endoscopy exclusion criteria: * patient's reject * patients with hearing impairment or neurological deficits * patients taking medicine that can affect the central nervous system * history of adverse drug reactions * glasgow coma scale ≤ 15 * could not undergo the endoscopy * could undergo the endoscopy, but do not undergo uppp
study of the development of human immune system of newborns by antigen chips

Conditions: Antibody Immune Profile

Summary: the immune system is a dynamic, constantly evolving network. excluding autoimmune diseases, healthy individuals are also known to have a large number of circulating antibodies that can recognize proteins of their own tissues. these antibodies are known as natural antibodies and previous studies suggested that some features of these "self" components are shared by individuals in certain physiological states. thus, monitoring self immunoglobulins can provide an overview of the various states of the immune system. to do so, and in the process to obtain systems biology view of the immune system, the newly developed antigen chip technology has been used. to further investigate this subject we plan to carry out broader investigations that will be conducted in collaboration with the group of prof. eshel ben-jacob from the university of tel-aviv and prof. irun cohen from the weizmann institute that have the required experimental and analytical expertise and facilities. the studies will include follow-up on the immune state of babies and their mothers for several months post birth using the antigen chip and analyzed by the immune holography method. the investigations will also include comparative studies between the immune signature of different body fluids, the effects of feeding, and the effect method and time of labor.

antibody reactivities are traditionally studied by their individual reactivities to one or only a few antigens, whereas only a small number of studies have focused on the repertoires of antibodies to large numbers of defined antigens. only recently, a new technology for system level analysis, the immune microarrays (or antigen chips) was introduced \[quintana 2004, quintana and cohen 2004, robinson 2006\]. this technology is capable of detecting patterns of antibodies binding to many hundreds of antigens, foreign or self and thus allowing a systems biology view of immune system. to create the antigen chips, a robotic apparatus is used to spot the antigen molecules of choice - proteins, peptides, sugars, lipids, nucleic acids - to a coated glass slide. these antigens are covalently linked to the surface of the slide and a drop of blood serum or any other body fluid can be tested for antibodies binding to hundreds of these antigen spots. the subject's bound antibodies are detected using fluorescence-labeled second antibodies and the reactions are monitored by laser activation.

Eligibility criteria:
inclusion criteria: * term and preterm newborns and their mothers * age 1 day to 7 weeks exclusion criteria: * maternal immune dieases * major congential malformations

Keywords: antibody immune profile preterm c-section breastfeeding