Kornimate/medical-research-clean huggingface dataset:
evaluation of lower extremity tissue perfusion with polarized laser light

Conditions: Diabetic Ulcer; Perfusion

Summary: the aim of this study is to test the feasibility of using polarised green laser and cmos camera in order to assess the tissue perfusion of lower extremity ulcers in patients suffering from diabetic foot by comparing this method with the percutaneous tissue oxygen tension examination which is currently the "gold standard" examination.

an objective assessment of blood supply and oxygen delivery to the damaged tissue in patients with diabetic ulcer is very problematic with various currently accepted auxiliary examinations. these tests include measuring blood pressure ratio between the ankle or toes arm (abi \\ tbi), sonar doppler examination of the lower limb arteries, and percutaneous tissue oxygen tension examination (tcpo2). each of these tests, along with the obvious advantages esprit ability to assess a non-invasive blood as number of disadvantages. as the blood supply to the tissue is the most important healing of the tissue regardless of the type of intervention chosen (conservative treatment includes systemic antibiotics or surgical debridement), there is clear necessity for a non-invasive test with high reliably assessing tissue perfusion in patients with diabetic ulcers. recently, a new a method for assessing multiple features in vital tissues using polarised laser light was introduced. the technique is based on tracking temporal changes of reflected secondary speckles produced in the skin when being illuminated by a laser beam. change in skin's temporal vibration profile is generated by time varied oxygen concentration caused these temporal changes. this technology of nanometer motion sensing allows, according to studies already carried out, monitoring parameters such as blood pressure, pulse rate and heart rhythm, glucose concentration in the blood substances and alcohol, oxygen saturation and intraocular pressure. in this study the investigators will examine, non-invasively, the tissue around the lower limb ulcers of 30 diabetic patients, beginning with the tcpo2 examination followed by the polarised laser light and complementary metal-oxide semiconductor (cmos) camera examination, and analysing the data in order to determine the ability of the latter method for assessing the tissue oxygen pressure.

Eligibility criteria:
inclusion criteria: * patients suffering from chronic diabetic ulcers exclusion criteria: * patients after amputation of some part in the lower limb * patients with acute infection on bony involvement
impact of antiobesity medications on appetite and appetite-related hormones and metabolites.

Conditions: Obesity; Drug

Summary: this study aims to explore how anti-obesity medications (aoms) like semaglutide and tirzepatide affect appetite and energy intake. researchers will examine two groups: one just starting aoms and another that has already achieved significant weight loss and maintained it. by conducting meal challenges at different stages of medication use, the study will assess feasibility of the methods and gather preliminary data to design a larger, future study.


Eligibility criteria:
inclusion criteria: * adult males and females with a bmi of 30-45 kg/m2 (early group), or a bmi of 30-45 kg/m2 prior to weight loss achieved through medication (late group) * age, 25-60 years old * passing medical and physical screening, and analysis of blood and urine screening samples * anticipated to start or are already prescribed aoms (semaglutide or tirzepatide) * 6-months weight stable (early group) or 3 months weight stable at current weight (late group) * women of reproductive age must be using an effective form of contraception exclusion criteria: * diagnosed with type 1 or 2 diabetes * smoker * previous surgical treatment or device-based therapy for obesity * chronic or acute pancreatitis * clinically significant gastric emptying abnormality * uncontrolled hypertension or hypo/hyperthyroidism * cardiovascular event 3 months within screening * acute or chronic hepatitis * inability to tolerate beef, eggs, and cheese * women who are pregnant * women who are nursing

Keywords: appetite-related hormones appetite metabolites
transcranial magnetic stimulation: treatment trial for depressed adolescents

Conditions: Depression

Summary: this is a study to assess the effectiveness and safety of repetitive transcranial magnetic stimulation (rtms) as a treatment for depressed 13-18 year olds. in rtms high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarizing neurons. no anesthetic is required and the treatment in subconvulsive. recent studies suggest that rtms can be an effective treatment for depressive illness in adults (loo and mitchell, 2005) and appears to be quite safe. minimal data of tms use in adolescents psychiatric disorders. data only existed in seven patients of the four that were depressed two showed improvement in their depression (quintana, 2005). no sham-controlled studies have been conducted. the investigators wish to assess this in a sham-controlled study of 30 adolescents. the investigators hypothesize that rtms will have an antidepressant effect and produce no neuropsychological impairment.

the study has two phases: the sham-controlled phase and an open phase. sham-controlled phase participants are randomly assigned to an active or sham tms condition. open phase following the sham controlled period participants participants in the sham rtms condition will be offered active rtms. participants will have the opportunity to receive up to 6 weeks of active rtms.

Eligibility criteria:
inclusion criteria: * dsm-iv major depressive episode of no more then 3 years. * montgomery-asberg depression rating scale score of 20 or more. * aged between 13 and 18. * may or may not be taking antidepressant medication. exclusion criteria: * patient (or family is patient is under 18)not able to give informed consent. * failure to respond to ect in current or past episodes of depression. * significant other axis 1 psychiatric disorders e.g. schizophrenia. * in imminent physical or psychological danger and needs a rapid clinical response due to inanition, psychosis or high suicide risk. * drug or alcohol abuse currently or in the last month. * history of neurological illness e.g. epilepsy; neurosurgical procedure * mental in the cranium, a pacemaker, cochlear implant, medication pump or other electronic device. * women of child-bearing age whom pregnancy cannot be ruled out.

Keywords: tms treatment adolescents safety efficacy
absorption, metabolism and excretion (ame) study of [14c]edp-305 in healthy male subjects

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: a phase 1, open-label study of the absorption, metabolism, and excretion of a single oral dose of \[14c\]edp-305 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (inclusive) * able to comprehend and willing to sign an informed consent form * in good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ecg, vital signs measurements, and clinical laboratory evaluations. exclusion criteria: * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed). * donation of blood from 56 days prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.

Keywords: ame study
effect of outpatient classic ketogenic diet in epileptic children and adolescent.

Conditions: Refractory Epilepsy

Summary: this study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.

this research will be done to observe efficacy, safety, and tolerability of the classic ketogenic diet (ckd) on an outpatient basis without fasting, caloric and fluid restriction in children with and adolescents with intractable epilepsy. 30 children and adolescents with intractable epilepsy based on inclusion and exclusion criteria have been enrolled in the study, investigators prescribe them classic ketogenic diet. efficacy of the diet will be assessed through seizure rates, number of anti-epileptic drug used by the patients, and eeg changes. seizure frequency will be assessed by seizure record diary that is filled out by family of the patients and will be compared with data that will be taken at 1, 3 months after start of the diet. eeg will be taken at baseline and 3 months after start of the diet. patients will be reviewed at 1, 3 months after start of the diet at outpatient clinic. intolerances and complications will be documented at each clinic visits and via telephone calling during clinic visits intervals to evaluate tolerability and safety of the kd. for close monitoring of the complications along with blood tests and urinalysis investigators will do echocardiography and renal ultrasound at baseline and 3 months after start of the diet. laboratory values will be assessed at baseline and 3 months after start of the diet. also, nutritional status and growth of children will be assessed at baseline and 1, 3 months after start of diet.

Eligibility criteria:
inclusion criteria: * ages 1-18 years, * the patient has tried at least 3 different aed:s including one combination with two or more different aed:s. * the parents are willing to include their child in the study after written and verbal information. * patients with all types of epilepsy can be included. * the patient is submitted to our epilepsy center. exclusion criteria: * the patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated. * the patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet. * no history of hyperlipidemia * no history of renal stones * no previous treatment with ketogenic diet * beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (mcad), long-chain acyl dehydrogenase deficiency (lcad), short-chain acyld dehydrogenase deficiency (scad), long-chain 3-hydroxyacyl-coenzyme a (coa) deficiency, and medium-chain 3- hydroxyacyl-coa deficiency. * the family is expected to have compliance problems with treatment and/or seizure registration

Keywords: refractory epilepsy, ketogenic diet classic ketogenic diet seizure rate efficacy epilepsy
long term follow up of the dvr-a locking plate

Conditions: Distal Radial Fractures Treated With a DVR-A Locking Plate

Summary: the surgical treatment of wrist fractures (distal radius bone) has been changed by the introduction of a new plate design, the locking plate. this results in improved fixation and stabilisation of the fracture fragments allowing early movement. this type of plate has been increasingly used throughout the world but questions have been raised regarding the potential complications of the surgery, particularly nerve and tendon injury. the norfolk and norwich hospital has treated over 250 distal radial fractures with this type of plate. the investigators plan to recall these patients to asses their long term function, general satisfaction and radiological results.


Eligibility criteria:
inclusion criteria: * treatment between jan 2005 and march 2009 exclusion criteria: * under 16 * unable to consent * pregnant

Keywords: distal radial fracture volar locking plate
a dose randomization study of bulumtatug fuvedotin in tnbc patients previously treated with adcs

Conditions: Triple Negative Breast Cancer

Summary: the goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.


Eligibility criteria:
inclusion criteria * patient has measurable disease by recist v1.1 * recurrent or metastatic triple-negative breast cancer patients as per current asco/cap guidelines * patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload. * patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting. * provision of archival tumor tissue or fresh tumor biopsy. * capable of giving informed consent * male or female subjects aged ≥ 18 years. * subjects must be willing to receive blood transfusions if medically indicated. * ecog 0-1 * adequate hematologic and organ function * life expectancy of at least 3 months as assessed by the investigator * compliance with contraceptive requirement exclusion criteria: * have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other mmae based or nectin-4 targeted antibody-drug conjugates. * unstable cns metastasis requiring treatment in the last 28 days. * acute infection requiring iv treatment in the last 14 days. * grade ≥2 peripheral neuropathy. * pregnant or breastfeeding women. * life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk * any systemic anticancer therapy in the last 28 days prior to first administration of study drug. * active hcv, hbv or hiv infection unless well controlled with anti-viral therapy. * active or chronic corneal disorder, keratitis, corneal ulcerations or sjogren's syndrome. * have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled. * have been diagnosed with another primary malignancy except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or subjects with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. * have significant, uncontrolled or active cardiovascular disease * have active or a history of pneumonitis or interstitial lung disease that requires corticosteroid treatment. patients with radiation pneumonitis that does not require treatment is allowed. * have uncontrolled diabetes. * have received any strong cyp3a4 inhibitors within 14 days prior to the first dose of study drug. * subjects known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation. * history of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening. * have received a live vaccine within 30 days of planned start of study therapy.

Keywords: 9mw2821 bulumtatug fuvedotin
treatment of no-option cli by g-csf-mobilized pb-mnc

Conditions: PAD; Critical Limb Ischemia; Atherosclerotic Ischemic Disease

Summary: this study will investigate the efficacy of g-csf mobilized mononuclear cell injection of patients with pad who presented with no-option cli. forty no-option cli patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. the control group will be treated by medication and supportive treatment. the experiment group will be injected g-csf mobilized mononuclear cell ,medication. amputation free survival,ankle brachial index(abi), toe brachial index (tbi) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months.

this study will investigate the efficacy of g-csf mobilized mononuclear cell injection of patients with pad who presented with no-option cli. forty no-option cli patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. the control group will be treated by medication and supportive treatment. the experiment group will be injected g-csf mobilized mononuclear cell ,medication. ankle brachial index(abi), toe brachial index (tbi) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of pb-mnc in the experiment group. amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after pb-mnc therapy.

Eligibility criteria:
inclusion criteria: * patients with no-option cli who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months exclusion criteria: * recent myocardial infarction * severe valvular heart disease * after organ transplantation * cardiomyopthy( ef\< 25%) * liver failure * coagulopathy * hiv
the impact of addition of curcumin for 10 days triple therapy, on the eradication rate of helicobacter pylori infection

Conditions: Positivity for Helicobacter Pylori

Summary: background and aims * h.pylori is a common human pathogen by which almost 50% of the world population is infected. according to the accepted guidelines, once h.pylori infection has been diagnosed,first line therapy with three drugs should be given. the triple treatment includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is only 70-80%. * curcumin has many beneficial merits and it was also been demonstrated to be efficient in inhibition of h.pylori infection, in vitro.therefore we aim to investigate whether addition of curcumin to the standard triple therapy will increase the eradication rate of h.pylori infection. methods * 150 consecutive patients that will undergo esophagogastroscopy in our gastroenterology department and will be positive for h.pylori according to urease test and then by gastric biopsy, will be included. the patients will be randomized to two different treatments, according to binomial distribution. 75 patients will be treated with the standard triple therapy for 10 days and the other 75, will be treated for 10 days, with triple therapy combined with curcumin that will be given three times a day. * during the treatment the patients will complete an adverse effect's questionnaires. 6 weeks after the completion of the treatment the patients will undergo urea breath test to confirm eradication. patients will be asked to avoid antibiotics, bismuth compounds or proton-pump-inhibitor until the second urea-breath-test. * we will compare the eradication rate and the adverse effects between the two groups by using spss


Eligibility criteria:
inclusion criteria: * positivity for helicobacter pylori by urease test and gastric biopsy exclusion criteria: * prior treatment for h. pylori * allergy to penicillin * gastric outlet obstruction * pregnancy or breast feeding * inability to understand the informed consent
estudo longitudinal de saúde do adulto (brazilian longitudinal study of adult health )

Conditions: Diabetes Mellitus; Cardiovascular Diseases

Summary: the brazilian longitudinal study of adult health (elsa-brasil) aims to contribute with relevant information regarding the development and progression of clinical and subclinical chronic diseases, particularly cardiovascular diseases and diabetes. the investigators enrolled 15,105 civil servants from predefined universities or research institutes. baseline assessment (2008-2010) included detailed interviews and measurements to assess social and biological determinants of health, as well as various clinical and subclinical conditions related to diabetes, cardiovascular diseases and mental health. for the ascertainment of incident events, annual telephone surveillance is being conducted since 2009, and a second visit of interviews and exams is under way (2012-2014). long-term biological sample storage is provided for sera, plasma, urine and dna. baseline data is available for analyses, and collaboration via specific research proposals directed to study investigators is welcome. this multicenter study is chaired by a steering committee, made up of the coordinators and vice-coordinators of each of the six centers. no individual center coordinates the study. the six institutions listed in the contact details all sponsor the study.

full details of the study have been published in the american journal of epidemiology (http://aje.oxfordjournals.org/content/early/2012/01/10/aje.kwr294.full) and the international journal of epidemiology (http://ije.oxfordjournals.org/content/early/2014/02/27/ije.dyu027.abstract), as listed in the references here. both articles are available in full text for download without charge.

Eligibility criteria:
inclusion criteria: * age 35-74 years, * active or retired employees of the institutions involved or affiliated institutions. exclusion criteria: * current or recent (\<4 months prior to the first interview) pregnancy, * intention to quit work at the institution in the near future, * severe cognitive or communication impairment and, * if retired, residence outside each center´s corresponding metropolitan area.

Keywords: diabetes mellitus cardiovascular diseases cohort studies hypertension obesity smoking social class
isolation and characterization of blastocystis hominis as apotential human pathogen

Conditions: Blastocystis Hominis Infections

Summary: * detection of the presence of blastocystis hominis among outpatients presented with git symptoms at assiut university hospitals in comparison with those in control group. * assessment of different culture techniques for detection, and isolation of blastocystis hominis. * molecular identification of blastocystis hominis using polymerase chain reaction (pcr).

blastocystis is a genus of single-celled parasites belonging to a group of organisms that are known as the stramenopiles . blastocystis consists of several species, living in the gastrointestinal tracts of humans and farm animals. many different species can infect humans and would be identified as blastocystis hominis depending on the sequencing of the gene encoding the 18s rrna . among the subtypes recognized, st1-8 could colonize humans as well as animals. infection with b. hominis has a worldwide distribution with infection rate reaches up to 60% in developing countries. initially b.hominis was accepted as a harmless commensal in the intestinal tract, but recently it was implicated as a pathogen. as it able to produce a cysteine protease which breaks up the mucosal iga antibody. b.hominis infection has been associated with several gastrointestinal symptoms, even though most cases are asymptomatic, it is also play a significant role in some chronic gastrointestinal illnesses as irritable bowel syndrome (ibs). blastocystis spp. are polymorphic parasites with multiple morphological forms including vacuolar, multivacuolar, granular, ameboid, and cystic forms. at least two out of three infections may be missed during microscopic detection of b.hominis due to their polymorphic nature, and the possibility of confusion with yeast, cyclospora spp. or fat globules. . different studies suggested that it multiply rapidly in culture medium and considered it a sensitive method for diagnosis of b.hominis . recently molecular diagnosis by polymerase chain reaction (pcr) is considered the most sensitive method for the detection of b.hominis.

Eligibility criteria:
inclusion criteria: * the persons selected for the study are those who are: 1. suffering from any git manifestations, attending outpatient clinics of internal medicine and tropical medicine departments at assiut university hospitals (case group) 2. clinically free persons undergo routine stool analysis for any reasons other than git complaint.(control group) exclusion criteria: * we will exclude any patient who received antibiotic or anti-parasitic drugs the past 4 weeks prior to sample collection.