Kornimate/medical-research-clean huggingface dataset:
study on safety and efficacy of monopolar radio frequency device for facial skin tightening

Conditions: Skin Aging

Summary: objective: the goal of this clinical trial is to evaluate the safety and efficacy of the volnewmer monopolar radiofrequency device developed by classys inc. this study is a prospective, single-center, single-arm, pilot clinical trial. research questions: 1. does the volnewmer device improve skin elasticity? 2. is the safety profile of the volnewmer device acceptable? subject procedures: subjects will: * receive a single treatment session using the volnewmer device. * attend follow-up visits over a 12-week period to assess improvements in elasticity and safety. the primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the cutometer r7. secondary outcomes include the global aesthetic improvement scale (gais). safety assessments involve monitoring treatment-emergent adverse events (teaes) associated with the application of the investigational medical device.


Eligibility criteria:
inclusion criteria: * subjects who are aged 19 to under 65 at the time of consent. * subjects who seek improvement in facial skin elasticity (both cheeks). * subjects who agree not to undergo other procedures affecting skin elasticity during the study. * subjects who provide written consent and commit to full trial participation. exclusion criteria: * subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial) * subjects with inappropriate skin conditions or treatment history * subjects with allergies or predispositions * subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing. * subjects with lifestyle or other unsuitable conditions (smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women) * subjects deemed inappropriate by the investigator

Keywords: volnewmer monopolar radiofrequency device mrf skin tightening facial skin treatment skin elasticity
the effect of thyroid hormon levels on the corneal measures

Conditions: Thyroid Disorder; Corneal Opacity

Summary: in this cross-sectional comparative study, it is aimed to investigate the topographic measurements,aberrometrics and densitometrics values of corneas in hypothyroid and hyperthyroid patients compared to healthy individuals. a number of 20 hypothyroid patients (group i), 20 hyperthyroid patients (group ii), and 20 age-matched healthy controls (group iii) have been recruited. the pentacam high resolution imaging system is used to determine corneal topographic measurements,aberrometry and densitometry.

thyroid hormone diseases can cause different symptoms and signs in the body according to the hormone levels, particularly in the eyes. corneal tissue can be affected by many biochemical and hormonal factors, and many ocular surface and systemic diseases can affect the cornea.hyperthyroidism has been shown to cause symptoms such as conjunctival chemosis, proptosis, increased intraocular pressure, limitation to globe movements due to the restriction of extraocular muscles, increased orbital volume, increased risk of glaucoma with inflammation in the trabecular meshwork and exposure keratopathy, especially in graves' disease. in the case of hypothyroidism, studies have shown fluid retention and edema in all body tissues, thereby resulting in increased thickness in the cornea, as well as a decrease in corneal hysteresis, which increases the risk of glaucoma. in this study, it is aimed to assess whether thyroid hormone changes affect those parameters by objectively measuring corneal changes via corneal topography, corneal densitometry and corneal aberrometry.

Eligibility criteria:
inclusion criteria: * thyroid hormone disorder patients with a novel diagnosis * age-matched healthy individuals without any systemic disorder (e.g., diabetes mellitus, hypertension, rhematoid artritis, asthma etc.) exclusion criteria: * having a spherical or cylindrical refractive error of \>1.0 degrees, * congenital corneal dystrophies, corneal ectasia, corneal ulcers or scars, keratitis, ocular surface infections, keratoconus, * a history of ocular trauma, * uveitis, * glaucoma, * a history of contact lens wear, * a history of ocular surgery, * dry eye diseases

Keywords: thyroid disorder corneal opacity corneal aberrations
pilot study of auto-immune abnormalities associated with down syndrome

Conditions: Down Syndrome With and Without Auto Immune Abnormalities

Summary: the purpose of the study is to identify biological data linked to auto immune abnormalities associated with down syndrome.


Eligibility criteria:
inclusion criteria: * free and complete trisomy 21 * aged between 8 and 36 years * biological or clinical signs of auto-immune disorder (group 1) * no sign of auto-immune disorder (group 2) exclusion criteria: * any antimitotic or immune depressing treatment during the last 6 months * current infectious disease * corticosteroid therapy in the last 3 weeks * pregnancy

Keywords: down syndrome, humans,clinical study,immunity, autoimmunity,
homeopathy for post-operative (c. section) recovery

Conditions: Cesarean Section

Summary: the planned study will be conducted in a prospective, randomized, double blind placebo controlled manner. two "anti-traumatic" homeopathic remedies (arnica montana and staphysagria) will be used. the selection of these remedies was based on a previous trial that showed a statistical difference in hemoglobin levels favoring pregnant women treated with these drugs following delivery. the proposed study will focus on the post-operative recovery of women undergoing cesarean section. according to homeopathic principles, these two remedies are believed to improve the "vital force", and will therefore improve convalescence following surgery in the study group. the study will include 90 women between the ages of 18 and 50 years who are scheduled for elective cesarean section. exclusion criteria are: obesity (above 100kg), malignancy, psychiatric illness, diabetes and multipara pregnancies. participants will be inducted following a detailed explanation by an md and signing of an informed consent form, and then subdivided randomly into three groups numbering 30 in each: two groups will be treated with homeopathic drugs of varied doses, and the third will get a placebo remedy which is indistinguishable from the other drugs. outcome measures will include: 1. blood loss - as estimated by a reduction in serum hemoglobin levels. 2. pain -to be evaluated by a numerical rating score (nrs) 3. analgesic use 4. length of post-operative stay and complications. 5. quality of life outcomes - to be assessed using the mos sf-36 questionnaire at one and four weeks following surgery. although not expected, adverse events will be monitored. if, as we anticipate, the homeopathic treatment proves to be both safe and effective in shortening the duration of post-operative healing, this will have significant implications, with respect to both healthcare costs and patient suffering. it will also open the door for further research in the field of trauma medicine, as well as other stress-related illness.


Eligibility criteria:
inclusion criteria: * women hospitalized for elective c. section, from the 1st to 3rd pregnancies. * age \< 50 years * body weight \< 100 kg * signing of informed consent form exclusion criteria: 1. suspected/proven malignancy 2. underlying axis-1 psychiatric illness 3. age \< 18 years 4. diabetes mellitus (niddm/iddm) 5. unable to comply with study proceedings

Keywords: caesarian section homeopathy pain analgesia
effect of homocysteine and asymmetric dimethylarginine on cardiovascular events in hemodialysis patients

Conditions: Chronic Renal Failure; Hemodialysis; Atherosclerosis

Summary: homocysteine (hcy) and asymmetric dimethylarginine (adma) have recently been recognized as potential risk factors for atherosclerosis in the general population, and the metabolism of each of these substances seems to be closely related. this study investigates the association between these substances, and whether elevated serum levels of hcy and adma would be related to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (hd) patients.

objective- homocysteine (hcy) and asymmetric dimethylarginine (adma) have recently been recognized as potential risk factors for atherosclerosis in the general population, and the metabolism of each of these substances seems to be closely related. this study investigates the association between these substances, and whether elevated serum levels of hcy and adma would be related to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (hd) patients. methods- the subjects were recruited from both day-time and night-time hd patients at maruyama hospital. the study inclusion criteria were those patients who had been receiving hemodialysis therapy for more than 6 months, were in a stable condition and were under 70 years old. the degree of atherosclerosis was evaluated by four indices involving the carotid artery intima-media thickness (imt), carotid artery plaque, percentile of calcification index in the abdominal aortic wall (aci) and elongation of the thoracic aorta. at the same time, plasma hcy and adma were measured. after the initial laboratory examination and evaluation of the degree of atherosclerosis, all the patients were followed up for 5 years.

Eligibility criteria:
inclusion criteria: * the study inclusion criteria were those patients who had been receiving hemodialysis therapy for more than 6 months, were in a stable condition and were under 70 years old. exclusion criteria: * any patients showing signs of heart failure or a history of such apparent cardiovascular diseases as myocardial infarction, cardiac valve diseases and stroke were excluded.

Keywords: homocysteine asymmetric dimethylarginine atherosclerosis cardiovascular event hemodialysis
effect of acetaminophen on neurological outcome in acute ischemic stroke patients undergoing endovascular treatment

Conditions: Ischemic Stroke

Summary: neuro-inflammation response plays an important role in the development of acute ischemic stroke(ais). the aim of this study was to conduct a prospective randomized controlled study on the effect of acetaminophen on long-term neurological prognosis in ais patients undergoing endovascular treatment(evt). the primary outcome was the incidence of neurological independence (mrs 0-2, modified rankin scale) at 90 days after surgery. the secondary outcome measures were early neurological outcome (nihss score at 7 days after surgery or at discharge) and the incidence of symptomatic intracerebral hemorrhage during hospitalization. this study explored the effect of acetaminophen on the prognosis of neurological function of patients, and the expected results provide evidence of safety and effectiveness for acetaminophen to improve the prognosis of neurological function of patients, and provide theoretical and practical basis for the subsequent "new use of old drugs" of acetaminophen and large sample and multi-center clinical research or clinical application.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; computer tomography angiogram (cta), magnetic resonance angiography (mra), mra) or digital subtraction angiography (dsa) confirmed the presence of large intracranial artery occlusion (intracranial internal carotid artery, anterior cerebral artery, m1 and m2 segments of middle cerebral artery, basilar artery, posterior cerebral artery); endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, etc. was performed (within 24 hours of onset). the nihss score at admission was 6-26. the mrs score before onset was less than 2. patients or their legal representatives provided written informed consent exclusion criteria: the mrs score before the stroke was ≥2. intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc. patients had a history of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia. renal insufficiency with elevated serum creatinine (\> 2 times the upper limit of normal); severe hepatic insufficiency or liver disease, with elevations in liver enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or gamma-glutamyl transpeptidase) of more than twice the upper limit of the normal range; patients with severe active liver disease; patients with severe heart and lung diseases considered by the investigator to be ineligible for the study; dsa examination is contraindicated, severe contrast agent allergy or iodine contrast agent is absolutely contraindicated; women of childbearing age, pregnant or lactating women who have a negative pregnancy test but refuse to use effective contraception; inability to complete the study due to mental disorders, cognitive or emotional disorders; allergy to acetaminophen; other patients who were not included in the study in the opinion of the investigator (reasons indicated) -

Keywords: ischemic stroke endovascular treatments acetaminophen
evolution of corporeal composition in the perioperative period

Conditions: Gastrointestinal Cancer (Esophagus, Gastric, Pancreatic, Hepatic, Colorectal and Anal); Lung Cancer

Summary: denutrition and obesity are risk factors for perioperative surgical complications. in patient with cancer, incidence of denutrition is markedly increased. surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition. in this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and bioelectrical impedance analysis (bia).

body composition measurements will be performed before surgical procedure (7 days) and at day 1, day 5, 1 month, 3 months and 6 months after surgery. others data will be recorded including anthropometric measurements, nutritional intake, occurence of surgical complication, type of surgical procedure, type and stage of cancer, and ct-scan measurements of subcutaneous abdominal fat, visceral fat and peri-renal fat before surgery and at 6 months.

Eligibility criteria:
inclusion criteria: * gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal) * or lung cancer * and planned surgical resection * age \> 18 years exclusion criteria: * surgical procedure planned \< 48 h * pregnancy * presence of a cardiac stimulator

Keywords: gastrointestinal cancer lung cancer bioelectrical impedance analysis body composition perioperative
assessment of salivary bacterial level and dental caries experience in a group of egyptian children with black stained teeth

Conditions: Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth Stains

Summary: black stains (bs) are type of extrinsic discoloration of the tooth. it's characterized as dark lines or an incomplete coalescence of dark dots found mostly on cervical third of the crown. most studies worldwide found that children with the black stained teeth have low caries prevalence. a study on brazilian population also suggested that black stains might be protective factor against development of dental caries. a study reported that chromogenic bacteria were proposed as etiological factor in production of black stains.the most common microbiological composition of bs was found to be actinomycetes. dental examination and saliva samples collection will be done for black stained teeth children of outpatient clinic of pediatric dentistry and dental public health department, faculty of dentistry, cairo university. this research adopts null hypothesis; it assumes that there is no effect on dental caries experience in children with black stained teeth.


Eligibility criteria:
inclusion criteria: * patients with black stained teeth who were reported to outpatient clinic of pediatric dentistry and dental public health department, faculty of dentistry, cairo university ranging in age between 4-6 years. * with primary dentition. * both sexes will be included. * cooperative children. exclusion criteria: * having oral disease (such as peridotites, salivary gland disorder, and oral mucosal disease). * having autoimmune disease. * receiving any antibiotic treatment in the past three months. * parents refuse to sign the consent
evaluation of efficacy and safety of elexacaftor/tezacaftor/ivacaftor (elx/tez/iva) in cystic fibrosis subjects without an f508del mutation

Conditions: Cystic Fibrosis

Summary: this study evaluated the efficacy, pharmacodynamics (pd) and safety of elx/tez/iva in participants 6 years of age and older with a non-f508del elx/tez/iva-responsive cystic fibrosis transmembrane conductance regulator gene (cftr) mutation.


Eligibility criteria:
key inclusion criteria: * participant has a qualifying elx/tez/iva-responsive cftr mutation and does not have an exclusionary cftr mutation * forced expiratory volume in 1 second (fev1) value \>=40% and \<=100% of predicted mean for age, sex, and height key exclusion criteria: * history of solid organ or hematological transplantation * clinically significant cirrhosis with or without portal hypertension * lung infection with organisms associated with a more rapid decline in pulmonary status other protocol defined inclusion/exclusion criteria may apply.
assial - anti tnf treatment in ankylosing spondylitis: an observational cohort study in italy

Conditions: Ankylosing Spondylitis

Summary: observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-tnf.

retrospective and prospective 150

Eligibility criteria:
inclusion criteria: retrospective:12 months at least first anti-tnf therapy prospective: at maximum 6 months observation as patients with axial involvement exclusion criteria: patients in other as studies involved
pregnancy with morquio syndrome - what are patients' perspectives and has ert changed them?

Conditions: Morquio Disease; MPS - Mucopolysaccharidosis

Summary: the present study seeks to interview women with morquio a and morquio b syndrome, to explore their concerns surrounding pregnancy and the impact of ert on their perspectives, in comparison with the control group of morquio b subjects for whom no ert treatment exists. interviews will be conducted by a health psychologist, in-person or over the telephone. data will be analyzed using maxqda 12.0 software and grounded theory. differences in thematic trends between morquio a subjects, for whom treatment exists, and a control group of morquio b subjects, for whom there is no treatment, will be compared.

the present study seeks to interview women with morquio a and morquio b syndrome themselves, to explore and discover their perspectives and concerns surrounding pregnancy and having biological children, the impact of the advent of ert for morquio a on their perspectives and concerns in comparison with the control group of morquio b subjects for whom no ert treatment exists, as well as what each group is being told by the medical community and others in their lives in this regard. interviews will be conducted by a health psychologist, either in-person or over the telephone. we will interview 1) those women with morquio syndrome who are known to have been pregnant and 2) those women with morquio syndrome who have not been pregnant and/or chose to adopt children. all information will be kept confidential, except as in accordance with georgia law relating to reporting of child or elder abuse, suicidal and/or homicidal intent. data will be analyzed using maxqda 12.0 software to develop code which can be used to describe and compare the data using grounded theory. differences in thematic trends between morquio a subjects, for whom treatment exists, and a control group of morquio b subjects, for whom there is no treatment, will be compared.

Eligibility criteria:
inclusion criteria: 1. documented clinical diagnosis of either mps iva or mps ivb, based on clinical signs and symptoms, documented reduced fibroblast or leukocyte galns enzyme activity or genetic testing confirming diagnosis. 2. subject is at least 15 years old. 3. subject is female. 4. subject is fluent enough in english to complete in-depth interview with pi. exclusion criteria: 1. patient has a clinically significant disease other than morquio which would confound the effects of morquio upon study variables. 2. any condition that, in the view of the investigator, places the patient at high risk of poor compliance or of not completing the study.

Keywords: pregnancy
validation of the stamp screening tool for pediatric nutritional risk

Conditions: Malnutrition

Summary: background: insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. in addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. this risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. in israel, nutritional screening in not conducted among children since there is no proper validated screening tool. study objectives: to test the accuracy of the stamp screening tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in clalit health care services clinics. in addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file. methods: 100 boys and girls aged 1 to 6, attending clalit health care services pediatric centers, will undergo an assessment using the stamp tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. these children shall also undergo a complete dietician assessment in order to examine the validity of the stamp tool. in addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements. a statistical analysis to examine the validity of the stamp tool shall be carried out using the kappa test (k) (30). the effect of the stamp tool use shall be calculated using the chi square test.


Eligibility criteria:
inclusion criteria: 1. children between 1 and 6 years old 2. children treated at the clinics participating in the study exclusion criteria: 1. lack of consent or lack of hebrew proficiency 2. children that not receiving treatment in day hospitalization at any hospital

Keywords: nutritional assessment children malnutrition