Kornimate/medical-research-clean huggingface dataset:
experience with h.p. acthar gel treatment of patients with nephrotic syndrome/proteinuria due to various etiologies and its effect on podocyte function

Conditions: Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function

Summary: patients with proteinuria to start treatment with acthar and watch a variety of clinical parameters with a goal of decreasing proteinuria between 50-100% over a period of nine months with every 3 months increasing the dose of medication until a decrease of either 50- 100 % of protein excretion is achieved. in addition addition podocyte function will be assessed monthly by measuring supar levels, tnf alpha, podocyte/creatinine levels as well as podocyte function studies.

patients with proteinuria/nephrotic syndrome with albumin/creatinine ratios of 50 or 24 hour urine protein of 500mg or greater will receive increasing doses of h.p. acthar gel starting with 20 units weekly or biweekly for 3 months after a one month washout observational period. the second three month period calls for 40 units biweekly, and the third three month period uses 80 units biweekly observing if the reduction in proteinuria reaches a goal of 50-100%. pre study clinical parameters include cbc diff, cmp, lipid with ldl, cortisol, acth, 24 hour urine for creatinine and protein, urine albumin/creatinine ratio, protein/creatinine ratio, bone density, hgba1c, weight , blood pressure, vital signs, and overall health questionaire. monthly cbc, cmp, prot/creat, alb/creat ratios, and one red top tube and one 50cc urine container to go to mgh charlestown for basic podocyte studies. the fourth -3 month observational period will be with tapering to stopping the dose of acthar and following the same monthly and the pre study parameters. a second year of observation will continue checking patients every other month for one year to determine the length of protein decrement observed in the first year. the study will conclude after the second year of drug free followup. biomarker studies of podocyte function will be done for the full 2 year period. final data analysis will conclude after the 2 year period of observation.

Eligibility criteria:
inclusion criteria: * patients with proteinuria as above. patients with controlled conditions below are candidates. exclusion criteria: * uncontrolled hypertension,diabetes mellitus, congestive heart failure, coronary artery disease, peripheral vascular disease.
objective evaluation of the effect of oculoplastic operations using the vectra m 3d imaging system

Conditions: Eyelid Ptoses; Ectropion Eyelids; Entropion;Eye

Summary: an objective assessment of that part of the spectrum of ophthalmic eyelid surgeries that focuses on correcting the position of entropy (e.g. ectropion, ptosis surgery) is very difficult - although it is possible to use different measuring parameters (distance of pupillary reflexes from the edges of the eyelid), comparing different distances on the face, exophthalmometry or the lid laxity test - the so-called snap-back test, but all these methods are based either on the subjective assessment of the examiner or on the correctness of the attached ruler, and their objectivity is therefore very low.

the goal of the project is to develop a methodology for evaluating the results of operations using a stereo photographic system, to objectively evaluate the functionality and results of various eyelid operations, and subsequently to expand the use of the device in other ophthalmological indications. different files will be created where the effect of different operations will be monitored in parallel. lateral canthal hinge surgery will be evaluated in the pilot group, and ptosis surgery through an anterior approach will be evaluated in the second group. in all patients, the position of the eyelids, their change before and after surgery, the periorbital volume, and the relation of the eyelids to the periorbital landscape will be assessed metrically. the vectra m3 device will be used for the measurement. the expected cohort size is 40 patients in each group.

Eligibility criteria:
inclusion criteria: * eyelid ptosis * eyelid entropion * eyelid ectropion exclusion criteria: * refusal to participate in the study * not signing the informed consent form * inability/reluctance to cooperate in the study

Keywords: vectra m3 device eyelid ptoses stereo photographic system eyelid surgery
studying corneal epithelial stability following limbal stem cell transplantation in cases of limbal stem cell deficiency

Conditions: Stem Cell Transplantation

Summary: integrity of the corneal epithelium is the function of intact limbal stem cells. the reduction in the population of lscs and their dysfunction result in abnormal corneal epithelialization and invasion of the corneal surface by the conjunctival epithelium with or without corneal neovascularization that is, limbal stem cell deficiency (lscd). different techniques have been developed to treat cases of limbal stem cell deficiency due to traumatic or congenital cases. recent innovations developed to predict the early stages of stem cell deficiency. one of these methods is measurement of the central epithelial thickness as it was found that limbal stem cell deficiency causes reduction of the central epithelial thickness. the aim of this study is to study changes in the corneal epithelial thickness at different quadrants of the cornea to observe the exact time of epithelial stability following stem cell transplantation.

patients with unilateral chemical ocular injury will be included in the study(12 eyes). all selected patients will receive a thorough explanation of the study design and aims and informed consent will be obtained in all patients. eyes of all participants will be subjected to: best corrected visual acuity, slit lamp examination and ocular ultrasound if no fundus view. staging of degree of limbal stem cell deficiency is done by roper hall classification and then the patient will have conjunctival limbal autologous transplant (clau). the patient will be followed up at a week, a month, 3 months, 6months and 9 months postoperative. corneal epithelial mapping will be done at the previous schedule in both the donated and the recipient eyes using anterior segment oct (optical coherence tomography) exclusion criteria: bilateral cases and patients with severe conjunctival scaring and symblepharon.

Eligibility criteria:
inclusion criteria: * patients between 15 to 70 years * unilateral limbal stem cell deficiency * grade 4 stem cell deficiency exclusion criteria: * cases with extensive symblepharon * cases with very poor visual acuity ( no light perception) * cases with posterior segment problem evident in ocular ultrasonography

Keywords: stem cell transplantation, stem cell deficiency clau
lipid-lowering therapy individualization

Conditions: Hypercholesterolemia

Summary: this clinical study will explore individual factors influencing statin pharmacokinetics in a cohort of 150 patients treated with atorvastatin.

atorvastatin is widely prescribed for the treatment of hypercholesterolemia to prevent the risk of cardiovascular diseases, a leading death cause in industrialized countries. there exists considerable inter-individual variability in response to statins, reflected by differences in lipid-lowering effect or risk of presenting adverse drug reaction; mainly myotoxicity. a plethora of different factors (demographic, genetic, physiopathologic, environmental...) have been tested to explain this variability but it lacks of pharmacokinetic (pk) data and/or replications of observations are rare and results remain inconclusive, probably because of non-adapted designs and no-clear driven-hypothesis but also due to a lack of scientific rationale and deep mechanistic understanding. this clinical study will explore individual factors influencing statin pk in a cohort of 150 patients treated with atorvastatin. the collection of meticulous clinical pk data and a rigorous statistical analysis will allow quantifying the effect of each identified parameter on statin pk and eventually, defining a population-based pk model taking into account the combined effect of all covariates in a quantitative approach. this innovative prospectively designed clinical study will ultimately allow predicting atorvastatin pk fluctuations and anticipating any inadequate dosing in clinical care.

Eligibility criteria:
inclusion criteria: * treatment with atorvastatin (any dose) exclusion criteria: * unable to provide informed consent
study on the pathogenesis of retinal vascular diseases based on body fluid metabolomics

Conditions: Metabolomics; Retinopathy; Etiology

Summary: through the analysis of metabolites in body fluids (intraocular fluid, plasma) of patients with retinal vascular diseases (retinal vein occlusion, diabetic retinopathy), the possible pathogenesis of retinal vein occlusion was explored.

1. clinical data of patients with rvo and dr were retrospectively studied to analyze their pathogenesis. 2. metabolomic studies were conducted on body fluids (intraocular fluid and peripheral blood) of patients with rvo and dr and control group to find out the differences and find new targets for the prevention and treatment of rvo and dr.

Eligibility criteria:
inclusion criteria: * age ≥18 years old * confirmed diagnosis of retinal vein obstruction and diabetic retinopathy through ophthalmic specialist examination exclusion criteria: * severe systemic diseases * pregnant and lactating patients
harnessing the disease signatures from endometrium and menstrual blood to identify avenues for the treatment of chronic conditions such as endometriosis and related pathologies: this is an observational study aimed at shedding light on women's health

Conditions: Endometriosis; Infertility; Endometrial Cancer; Adenomyosis, Endometriosis

Summary: many women's health conditions have limited treatments available and poor outcomes, in part due to the lack of understanding of disease processes and lack of data available. this study aims to build knowledge in women's health by leveraging the information we can gather from menstrual fluid and the uterus. by looking at samples from menstrual fluid and biopsies and associating it with health outcomes of the people donating these samples, we will be able to find new signatures of disease. this can help us find early diagnostic markers, better classify diseases and give us the tools that allow us to build the right models in the lab to find new treatments. by collecting this data, we will be able to identify patterns within given diseases that can help us cure them and derive the cells necessary to model the disease. the study is funded and undertaken by cycle therapeutics, a company with the mission of curing endometriosis. all women above the age of 16 will be eligible, although most samples will be collected from those who are menstruating or already undergoing biopsies/surgical tissue removal. women with endometriosis or suspicion of the disease are encouraged to take part, but participation of people without any symptoms or conditions is important to understand what the base healthy state looks like. most of the sample processing will be done within cycle and collection will occur at clinics or remotely, and can be as simple as pouring menstrual fluid from a cup into a tube to ship to cycle. the study will last four years, during which we hope to build a strong understanding of conditions affecting women. we will be able to provide health insight to donors after each donation, but the greatest value in this study will lie in the new treatments we can discover thanks to our novel understanding.


Eligibility criteria:
inclusion criteria: * menstruating exclusion criteria: * not menstruating

Keywords: menstrual fluid endometriosis tissue modelling
comparison of two potassium targets within the normal range in intensive care patients

Conditions: Thoracic Surgery; Cardiac Surgery; Critically Ill

Summary: rationale: it is well known that distinctly abnormal blood potassium values can cause serious complications such as cardiac arrhythmias. although potassium regulation is generally considered important, hardly any research has been done about potassium regulation in intensive care patients. the investigators hypothesize that different potassium target-values, within the as normal accepted range, may have different effects in critically ill patients. study design: a prospective trial comparing two different potassium target-values. potassium will be tightly regulated with the already fully operational grip-ii computer program. study population: 1200 adult patients admitted at the thoracic intensive care unit of the university medical center groningen. intervention: comparison between two variations of standard therapy: potassium target-value of 4.0 mmol/l versus 4.5 mmol/l. main study parameters/endpoints: the primary endpoint is the incidence of atrial fibrillation or atrial flutter from icu-admission to hospital discharge. secondary endpoints are serum levels of potassium and the other main electrolytes, renal function and renal potassium excretion, the relation with insulin and glucose, the cumulative fluid balance, (icu) length of stay and mortality.


Eligibility criteria:
inclusion criteria: * all adult patients admitted to the thoracic and surgical icu of the university medical center groningen. * computerized potassium regulation with grip-ii exclusion criteria: * patients who are not potassium regulated with grip-ii (patients who take their own meals).

Keywords: intensive care unit potassium atrial fibrillation cardiac surgery critically ill patients post cabg and/or valvular surgery critically ill patients not post cabg and/or valvular surgery coronary artery bypass graft
the program-study: awake mapping versus asleep mapping versus no mapping for glioblastoma resections

Conditions: Glioblastoma

Summary: the study is designed as an international, multicenter prospective cohort study. patients with presumed glioblastoma (gbm) in- or near eloquent areas on diagnostic mri will be selected by neurosurgeons. patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, ac); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (meps, sseps, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). all patients will receive follow-up according to standard practice.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years and ≤ 90 years 2. tumor diagnosed as gbm on mri as assessed by the neurosurgeon 3. tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on mri (sawaya grading ii and ii) 4. the tumor is suitable for resection (according to neurosurgeon) 5. written informed consent exclusion criteria: 1. tumors of the cerebellum, brain stem or midline 2. multifocal contrast enhancing lesions 3. medical reasons precluding mri (e.g. pacemaker) 4. inability to give written informed consent (e.g. because of severe language barrier) 5. second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin
a modified method for blind bedside placement of post-pyloric feeding tube.

Conditions: Nutritional Support, Catheterization, Post-pyloric Feeding Tube, Dysphagia

Summary: to compare efficacy and safety of a new modified post-pyloric feeding tube bedside catheterization with corpak 10-10-10 protocol and electromagnetic guided catheterization for treatment of patients with dysphagia and at high-risk of aspiration pneumonia. we conducted a single-center, single-blinded, and randomized controlled clinical trial. a total of 63 patients were treated with the non-gravity type corflo gastrointestinal feeding tube between 2017.1 and 2019.1 using different procedures: in the m group, patients underwent modified post-pyloric feeding tube bedside placement; in c group, patients underwent conventional corpak protocol; in em group, patients received standard electromagnetic guided tube placement.


Eligibility criteria:
inclusion criteria: * all patients had dysphagia that could not be alleviated within 48 hours * high-risk status with aspiration pneumonia, including consciousness disorder caused by various diseases, severe dementia, bed rest, gastroesophageal reflux, hiccup, gastric retention, achalasia of pyloric. * can't receive nasogastric tube feeding. exclusion criteria: * the previous history of upper abdominal surgery. * gastroduodenal ulcer and esophagogastric varices; * severe sinusitis and nasal bone fracture; * patients with recent gastrointestinal bleeding, intestinal obstruction, ischemic bowel disease, and epistaxis; * patients with electromagnetically-guided catheterization should additionally exclude implantable cardiac defibrillator, implantable cardiac pacemaker or diaphragm pacemaker.
clinical and microbiological evaluation of periodontal treatment of diabetic patients: a longitudinal study

Conditions: Chronic Periodontitis; Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.

all the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. visible plaque index (vpi) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). bleeding on probing (bop) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. probing depth (pd - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (gr - distance between the cementoenamel junction and gingival margin) and clinical attachment level (cal - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. for blood parameters, an outside laboratory will perform all blood analysis. it will be requested for each subject with diabetes (dg) at baseline, each 3 months post-treatment. fasting plasma glucose (fpg) will be expressed in milligrams per deciliter and hba1c will be expressed as a percentage. statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.the data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronical periodontitis according to lopez et al. 2002 (one or more teeth with at least one site with pd \>= 4mm or cal \>= 3mm); * and have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders. exclusion criteria: * any systemic diseases or complications (except type 2 diabetes mellitus) such as cardiovascular disease, alzheimer's, lung or brain diseases and metabolic syndrome; * use of antibiotics or periodontal treatment within the past 6 months; * long-term administration of anti-inflammatory or/and immunosuppressive agents; * current smoker or former smoker for the past 5 years; * pregnant or breastfeeding; * and presence of orthodontic appliances.

Keywords: dental scaling blood glucose hemoglobin a, glycosylated
gonorrhea and chlamydia hiv-infected men who have sex with men

Conditions: HIV Infection; Chlamydia; Gonorrhea

Summary: this study will estimate the rates of asymptomatic chlamydia and/or gonorrhea in the oropharynx, rectum and urethra (urine) of hiv infected men who have sex with men at a specialty care center and compare it to the rates in douglas county, using nucleic acid amplification tests.

hypothesis: men who have sex with men (msm) are at higher risk for sexually transmitted diseases. currently, free testing for sexually transmitted diseases is only being performed in urine samples. investigators hypothesize that the rates of both gonorrhea and chlamydia will be higher when testing includes more than one anatomical site (rectum and oropharynx). the aim of the study is to estimate the rates of asymptomatic chlamydia and/or gonorrhea in the oropharynx, rectum and urethra (urine) of hiv infected men who have sex with men at the specialty care center of the university of nebraska medical center and compare to the rates in douglas county, using nucleic acid amplification tests.

Eligibility criteria:
inclusion criteria: * hiv infection * men with history of sex with men (including transgender and bisexual) * older than 19 years of age * asymptomatic at the time of visit. exclusion criteria: * active sexually transmitted disease symptoms in the oropharynx. * recent treatment for chlamydia or gonorrhea within 3 weeks. * treatment with antibiotics active for chlamydia or gonorrhea within the last 2 weeks: doxycycline, quinolones and azithromycin, and cefixime. * women. * inability to complete the questionnaire in english or spanish.

Keywords: hiv infection men who have sex with men chlamydia gonorrhea
efficacy of wet cupping on blood pressure among hypertension patients

Conditions: Hypertension

Summary: this research proposal is submitted to fulfill the requirement of the phd degree of community medicine saudi board at the joint program of family and community medicine in jeddah, saudi arabia. background: cupping is an ancient treatment remedy that has been used for many centuries in many parts of the world. in the middle east, wet cupping "hijama" is still a popular treatment because of its religious background. despite of that, it still has little scientific evidence that proves its efficacy. many hijama healers claim that they have observed dramatic improvement in blood pressure control of hypertension patients. not many studies support that. this study should help to prove or disprove this hypothesis. objectives: * to determine the efficacy of wet cupping on blood pressure among high blood pressure patients. * to assess the incidence of wet cupping side effects in the intervention group. methods: the study design is a randomised controlled trial. there will be an intervention group of high blood pressure patients who will perform hijama in addition to their usual management, and a control group of high blood pressure patients who will receive their usual anti-hypertension management only. there will be 4 weeks follow up period. after that, data entry, analysis and interpretation will take place. hypothesis: wet cupping has an effect on blood pressure in adult hypertension patients


Eligibility criteria:
inclusion criteria: * high bp at the time of the study (sbp 140 mmhg or more and/or dbp 90mmhg or more). for patients with dm, high bp is defined as sbp 130 mmhg or more and/or dbp 85mmhg or more. * age between 19 and 65 years old. * males and females exclusion criteria: * grade iii hypertension (sbp 180 mmhg or more and/or dbp 110 bp or more). * patients with very high added risk,according to the saudi hypertension management guidelines. by excluding the patient who have associated clinical conditions which are: cerebrovascular disease, heart disease, renal disease, peripheral vascular disease and advanced retinopathy. * patients with secondary hypertension. * pregnant women. * if the patient performed dry cupping, wet cupping or acupuncture during the past 6 months.