Kornimate/medical-research-clean huggingface dataset:
engagement 2.0 forms of consent for data (re-)use

Conditions: Alzheimer Disease, Early Onset; Mild Cognitive Impairment

Summary: the objective of this qualitative study is to create a better understanding of patients' mental model of health data engagement interfaces and tools (such as dynamic consent). the researchers will focus especially on those people who - plausibly - require adjusted communication particularities and interaction modalities due to a cognitive impairment stemming from a neurodegenerative disease. taking into account the specific characteristics of patients with dementia, the goal of this study is to investigate how to communicate according to patients' personal skills and capabilities and identify both the proper support mechanisms for engagement 2.0 consent as well as feedback mechanisms (return of research results). through a focus group \& interview setup, this study will discern design requirements and propose design recommendations for the (future) development of health data engagement interfaces.

while unprecedented amounts of multimodal health data become increasingly available and their secondary use in clinical and (bio)medical research holds great promise, people's agency over this data is in contention. in the context of biobank research, patient-centered initiatives such as 'dynamic consent' have been proposed as a way to provide people with ownership over their health data by allowing for granular expression of their consent preferences using a digital interface. although such interfaces have been positively assessed within their original biobank context, more heterogeneous audiences will need to be considered if such a socio-technical tool is to be adopted widely and provide people ownership over their electronic medical records. one subset of people that will require adjusted functionalities and interaction modalities in this regard are those with a cognitive impairing condition like dementia, given the illness' consequences on decision making capacity. this study qualitatively explores the user \& social requirements of a tool like dynamic consent if it is to be used in a meaningful way also by people with dementia and their (informal) carers. we report findings from interviews and an expert focus group with people with dementia, their caretakers, and experts to depict their views and requirements on a tool like dynamic consent.

Eligibility criteria:
inclusion criteria: * no diagnosed cognitive impairment but first-degree relative with ad * mild cognitive impairment due to ad (diagnosed according to the nia/aa diagnostic criteria) * mild dementia due to ad (diagnosed according to the nia/aa diagnostic criteria) exclusion criteria: * patients with moderate to severe dementia due to ad, defined as mmse total score 20/30 or lower
efficacy and safety ofcacxl in the treatment of keratoconus with thin corneas

Conditions: Progressive Keratoconus

Summary: the aim of this study is to detect the safety and effectiveness of contact lens assisted corneal cross linking in managing progressive keratoconus with thin corneas cacxl was done for 40 eyes of 30 of keratoconic patients presented to cornea outpatient clinic in kasr alainy teaching hospital the udva ,bdva kmax, thinnest corneal thickness pre-operative and 9 months postoperatively and the endothelial cell count was measured preoperative and 3 months postoperative demarcation line was measured after 1 month by using asoct there was statistical significant difference in udva and bdva, there was stabilization of kmax there was decrease in endothelial cell count but not statistically significant according to results the procedure seems to be effective and safe un managing progressive keratoconus.

corneal collagen cross linking showed effective results in stabilizing progressive keratoconic corneas. it is the only treatment that halts progression of keratoconus, it was first described in 1998 by spoerl et al . a major limitation of the procedure that it cannot be used in corneas with pachymetry less than400 micrometers based on the fact that an irradiance of 0.37 mw/cm2 has been found to be cytotoxic for the endothelial cell layer. since the absorption coefficient for the human corneas is 70 cm-1 and the intended surface irradiance is 3.0 mw/cm2, the 0.37 mw/cm2 irradiance is reached at 300 microns depth. in a 400 microns thick cornea saturated with riboflavin, the irradiance at the endothelial level is 0.18 mw/cm2, which is a factor of 2 smaller than the damage threshold. therefore, the 400 microns limit is considered to be a safe limit to protect the endothelium and intraocular structures from the hazards of uv irradiation 12 however , the patients with advanced ectasia who are desperately in need for cxl , are the same ones who have thin corneas often below the threshold which is considered to be safe for cxl treatment however further studies with longer follow up and larger numbers of cases are needed to confirm our findings.

Eligibility criteria:
inclusion criteria: * age from 18 to 35years old mild , moderate and severe keratoconic patients with a corneal thickness from 360-400 µm at the thinnest location . exclusion criteria: * • previous corneal surgeries such as rings or crosslinking. * patients with stromal corneal scar. * other ocular pathology such as glaucoma or iridocyclitis. * patient with systemic diseases that likely affects wound healing such as insulin dependent diabetes mellitus. * patients with collagen vascular diseases, autoimmune or immune deficiency diseases. * pregnant or nursing women. * patients taking the following medications ; isotretinoin, amiodarone, sumatriptan. * other corneal pathology rather than keratoconus

Keywords: cross linking thin corneas advanced keratoconus
testing the effect of multiple weight management modalities for chronic disease risk reduction in a clinical setting

Conditions: Obesity

Summary: this project will test 3 methods of dietary changes in a weight loss clinic. participants will be randomized to one of 3 arms: low-carbohydrate diet, intermittent energy restriction, or hunger training. a maximum of 30 participants will be assigned to each arm. the goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic.

adult obesity, a common condition in the united states, is a well-established risk factor for the development of chronic diseases, including diabetes, heart disease, hypertension, and many types of cancer. however, research has not determined what type of diet is best for reducing weight and achieving optimal health outcomes. in this randomized trial, participants seeking care at a weight loss clinic will be assigned to one of three diets: low-carbohydrate, intermittent energy restriction, or hunger training. on the low-carbohydrate diet, participants will be instructed to consume less than 30 grams of carbohydrates per day. the intermittent energy restriction protocol will require participants to choose 2 non-consecutive days per week in which they will consume 500-650 calories. hunger training is a relatively new approach that involves teaching people to monitor their hunger symptoms and blood glucose, and to eat only when blood glucose is below a certain level. to our knowledge, these weight loss modalities have not been compared in a single, clinical study. the goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic. the goal will be achieved though the successful completion of the following aims: aim 1: to determine the feasibility of recruiting, retaining and maintaining the adherence participants in a randomized clinical trial testing 3 weight loss modalities. aim 2: to examine and compare the effect of 3 weight loss modalities on changes in anthropometric measures and metabolic and cancer-related health markers. aim 3: to evaluate and compare patients' perceived satisfaction with each weight loss modality.

Eligibility criteria:
inclusion criteria: * overweight/obese as indicated by bmi \>27 * age ≥ 18 * hba1c \<8.0 * fluent in english exclusion criteria: * cognitive state that precludes informed consent or adherence to study protocols * pregnant, breast-feeding, or planning to become pregnant within 6 months * a1c ≥ 8.0 * taking an anti-obesity medication * insulin-dependence * prior metabolic surgery * current laparoscopic adjustable gastric band ("lap band") use * experience of substantial weight changes (±5 kg or ±10 lbs) in the past 3 months

Keywords: weight loss diet modification body weight body weight changes ketogenic diet diet, carbohydrate-restricted fasting intermittent fasting hunger training
the effect of colchicine on platelet function profiles in patients with stable coronary artery disease

Conditions: Coronary Artery Disease

Summary: the effects of colchicine on cardiovascular health in patients with stable coronary artery disease have been shown to be beneficial due to its anti-inflammatory properties. this present study aims to explore the effects of colchicine on platelet reactivity in patients with coronary artery disease on dual antiplatelet therapy.

recent landmark clinical trials on the use of colchicine in patients with chronic coronary artery disease has led to its implementation as an fda approved drug for secondary prevention in patients with coronary artery disease. colchicine exerts a range of anti inflammatory effects which plays a major role in reduction of atherosclerosis and prevention cardiovascular events. this current study aims to investigate the effect of colchicine on platelet reactivity in patients with stable coronary artery disease already on dual anticoagulants.

Eligibility criteria:
inclusion criteria: * patients with stable coronary artery disease. * patients older than 18 years of age. * patients currently on dual anti platelets, aspirin and clopidogrel exclusion criteria: • patients already on colchicine
soy, bone and health in college females

Conditions: Osteoporosis; Obesity

Summary: this is a 16-week intervention to determine the efficacy of an isoflavone-rich soy based meal supplement to improve bone health and prevent weight and fat gain in 18-19 year old college females. the primary hypothesis is that participants who receive soy will have favorable changes in blood markers of bone and less weight and fat gain. the soy is provided by physicians pharmaceuticals, inc. (revival doctor-formulated soy protein).

the proposed study will be a 16-week randomized, double-blind, placebo-controlled trial designed to test whether a daily isoflavone-rich, soy-based meal replacement revival soy shake promotes favorables changes in bone biomarkers and attenuates weight gain in female college students. first-year college females were selected because of the potential for significant weight gain during their freshman year. the study will have a parallel design with two groups: the soy treatment group (soy; n = 60) and a casein-based control (con; n = 60). exclusion criteria include significant weight loss or gain in the past 3 months, vegetarians and heavy soy food consumers, national collegiate athletic association division i athletes, women with eating disorders, present illnesses, chronic disease, and those taking medications or herbal supplements known to affect body weight, body fat or bone. participants will be stratified based on bmi (18.0-24.9; 25-29.9; ≥30.0) and randomized to either soy or con groups. female college freshmen enrolled at the university of georgia will be recruited in the fall of 2005. the soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving. the control shake will have 20 g casein substituted for soy protein, and will be otherwise identical to the soy shakes. the shakes will be available in two flavors: chocolate and vanilla.

Eligibility criteria:
inclusion criteria: * 18-19 year old university of georgia college females of all races/ethnicities. exclusion criteria: * significant weight loss or gain, currently dieting to lose weight, are planning to lose weight, diet or begin an exercise program, under the age of 18, pregnant or intending to become pregnant, vegetarians, heavy soy food consumers, division i athletes, women with menstrual irregularities, eating disorders, present or chronic illness, and those taking medications known to affect bone, body weight or body fat.
safety and efficacy of "standardized" chip

Conditions: Coronary Artery Disease

Summary: in routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (pci). current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to pci may be reasonable in selected high-risk patients. the objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (chip).


Eligibility criteria:
inclusion criteria: * signed informed consent * non emergent pci of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft exclusion criteria: * subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or inr ≥2.5.) * history of recent (within 1 month) stroke or tia * allergy or intolerance to heparin, aspirin, adp receptor inhibitors
effects of music and comedy application on pain and kinesyophobia in patients with tka

Conditions: Arthroplasty Complications; Kinesiophobia

Summary: total knee arthroplasty (tka) is a surgical procedure used to restore painless joint function and increase patients' activities of daily living in patients with progressive knee osteoarthrosis. kinesiophobia can be seen in patients suffering from pain. it is stated that the incidence of kinesiophobia in tka patients is 24.4%. based on this information, this study was planned.

total knee arthroplasty (tka) is a surgical procedure used to restore painless joint function and increase patients' activities of daily living in patients with progressive knee osteoarthrosis. kinesiophobia can be seen in patients suffering from pain. it is stated that the incidence of kinesiophobia in tka patients is 24.4%. pain etc. while conditions can be relieved by pharmacological treatment methods, non-pharmacological treatments can be effective in relieving patients' pain. with the relief of pain, it will be possible to eliminate the kinesiophobia experienced by the patients. it is known that humor, which is among the non-pharmacological treatment methods, increases the pain resistance of the patients, reduces the stress hormone, and strengthens the immune system. it is reported in the literature that listening to music, another non-pharmacological treatment, is also effective in relieving pain after tka. for this reason, the study was planned to determine the effect of postoperative music and comedy films on kinesiophobia and pain in patients undergoing tka.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 who agreed to participate in the study, * patients undergoing tka * patients without a disabling psychiatric disorder exclusion criteria: * patients under the age of 18 who do not agree to participate in the study. * those who have a psychiatric diagnosis that prevents communication.

Keywords: music comedy movie kinesiophobia pain total knee arthroplasty
a clinical trial to evaluate the tolerability and pharmacokinetics of ckd-348(6)

Conditions: Hypertension; Dyslipidemias

Summary: a phase i clinical trial to evaluate the tolerability and the pharmacokinetics of ckd-348(6).


Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19 years. 2. body weight ≥55kg with calculated body mass index (bmi) of 18 to 30 kg/m2 3. those who meet the blood pressure criteria during screening tests: * systolic blood pressure: 90 to 139 mmhg * diastolic blood pressure: 60 to 89 mmhg 4. those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. 5. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ecg results at screening. 6. those who agree to contraception during the participation of clinical trial. 7. those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial. exclusion criteria: 1. those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 2. those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products. 3. those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month. 4. those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 5. those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products. * alcohol: man - 21 glasses/week, woman - 14 glasses/week (1glass: soju 50ml, wine 30ml, or beer 250ml) * smoking: 20 cigarettes/day 6. those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism and hypersensitive to sunset yellow fcf. 7. those who have genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption. 8. those who are deemed insufficient to participate in this clinical trial by investigators. 9. woman who are pregnant or breastfeeding.
vns-supplemented motor retraining after stroke

Conditions: Stroke, Acute

Summary: the goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.

to establish a link between the physiological mechanisms driving enhanced motor control in response to vns, subjects will undergo progressive training on a visuomotor task that requires fine gradation of voluntary motor output to control a moving object through target boundaries. in separate groups, vns or sham stimulation will be paired with movement when a minimal time-on-target (tot) is achieved.

Eligibility criteria:
inclusion criteria: individuals who have had a stroke: 1. diagnosis of first ever stroke 2. at least 6 months after stroke onset 3. motor-evoked potentials in hand/arm muscles 4. subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. all individuals: 5. between the ages of 18 and 75 years old exclusion criteria: individuals who have had a stroke: 1. hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators all individuals: 2. neurological disorder(s) influencing movement (besides stroke) 3. history of seizure or epilepsy 4. metallic brain implants 5. bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers 6. pregnant or expecting to become pregnant 7. difficulty maintaining alertness and/or remaining still 8. silicone or plastic allergy 9. history of vestibular disorders (eg, vertigo, meniere's disease, etc.)
relevance of sensitization to legumes in children allergic to peanut

Conditions: Allergy;Food

Summary: the objectives of this study are to determine in children allergic to peanut (i) the prevalence of sensitization to other legumes, (ii) the prevalence of allergy to each legume in patients who are sensitized to it (iii ) the severity of the allergy to legumes other than peanut

allergy to legumes is more and more frequent, especially in children allergic to peanut, with some severe reactions but little is known about cross-reactivity and clinical meanings of legumes sensitization in children allergic to peanut. all children with a confirmed peanut allergy and followed at the university hospital of nancy between january 1st 2017 and february 29th 2020 will be included in order to evaluate the prevalence of sensitization and allergy to other legumes in this population. in children allergic to peanut and to at least one other legume, we will evaluate the severity of the allergy and the sige profiles for peanut.

Eligibility criteria:
inclusion criteria: * confirmed allergy to peanut exclusion criteria: * no available information regarding sensitization and tolerance to legumes

Keywords: food allergy peanut legumes sensitization
evaluating the effectiveness of a handbook for parents of children newly diagnosed with food allergy

Conditions: Hypersensitivity, Food

Summary: the objective of this research is to evaluate the effectiveness of a handbook for parents of children newly diagnosed with food allergy. the handbook was developed to provide information and strategies to support families in effectively managing food allergies while maintaining positive quality of life. parents of children newly diagnosed with food allergy (within the past year) will be randomized into either the treatment condition (handbook) or a control condition (management of food allergy as usual). participants will complete study questionnaires online at three time points: baseline (this will be before receiving the handbook for the treatment group), post-intervention (2-3 weeks after baseline), and follow-up (2-3 months after baseline). data will be analyzed for change on study outcome measures and satisfaction with the handbook. parents in the control group will receive the handbook following the conclusion of their participation in the study.


Eligibility criteria:
inclusion criteria: * parents of children ages 0 to 18 years newly diagnosed with food allergy (within the past 12 months) * child's food allergy has been diagnosed by a physician * child has been prescribed an epinephrine auto-injector exclusion criteria: * non-english speakers, as the handbook (study intervention) is only available in english at this time.