Kornimate/medical-research-clean huggingface dataset:
adolescent type 1 diabetes cardio-renal intervention trial

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine whether use of blood pressure lowering drugs, angiotensin converting enzyme inhibitors (aceis) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.

subjects will be recruited from a pre-screened population of 3,000 young people with t1d aged 10 to 16 years based on assessment of risk for future cvd and dn. they will be randomised to a 2 x 2 factorial design contrasting the effects of acei, statins, or combination therapy to placebo over a maximum four year treatment period. minimisation of variation in albumin excretion rate, gender, age, diabetes duration, hba1c, total cholesterol and centre site will be undertaken at randomisation. analysis of the primary endpoint, change in albumin excretion will be undertaken on an intention to treat basis. secondary analyses will be undertaken on the basis of 'as treated' allowing for variance in compliance and allowing for subjects who show substantial change in hba1c levels. additional analyses will be undertaken to assess changes in the secondary objectives and to assess the overall effect of the intervention on quality of life and health economics.

Eligibility criteria:
inclusion criteria: 1. age 10 to 16 years. 2. t1d diagnosed for more than 1 year or c-peptide negative. 3. centralised assessment of acr based on six early morning urines deemed to be in upper tertile for risk after adjustment for age, gender, age at diagnosis and duration of disease. exclusion criteria: 1. non t1d, i.e. type 2 diabetes, insulin dependent diabetes related to monogenic disease, secondary diabetes. 2. acr based on six early morning urines deemed to be at low risk for subsequent development of cvd or dn. 3. pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial. 4. breast feeding 5. severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia. 6. established hypertension unrelated to dn. 7. prior exposure to the investigational products, statins and acei. 8. unwillingness/inability to comply with the study protocol. 9. other co-morbidities considered unsuitable by the investigator (excluding treated hypothyroidism and coeliac disease). 10. proliferative retinopathy. 11. renal disease not associated with type 1 diabetes.

Keywords: adolescence
turkish adaptation of segmental assessment of trunk control scale

Conditions: Down Syndrome

Summary: in infants with down syndrome at risk in terms of neurosensory motor development retardation, the level of trunk control can determine the level of trunk control towards motor development in infants with down syndrome. for this reason, the purpose of this study is to adapt the segmental assessment of trunk control scale to turkish by evaluating the motor development in children with down syndrome. it is the investigation of validity and reliability.

independent sitting of babies with down syndrome is very important because sitting is the primary position on improving play activities. it is a known fact that late acquisition of sitting posture has negative effects on gross motor skills such as crawling and walking as well as fine motor skills. the extent to which trunk development affects the developmental stages of the child and his performance in motor behaviors and skills should be evaluated. at the same time, trunk control should be evaluated at various periods in order to determine early intervention and treatment strategies in babies with down syndrome who are at risk for motor development.

Eligibility criteria:
inclusion criteria: * volunteer parents who have; * infant with down syndrome exclusion criteria: * have a serious medical history (serious cardiac problems, infantile spasm, leukemia) * presence of mss and pss-related problems * those with visual and auditory problems * having epileptic seizures * presence of musculoskeletal problems
effectiveness and safety of topical bevacizumab (avastin) for treatment of corneal neovascularization

Conditions: Corneal Neovascularization

Summary: purpose: to determine the efficacy and safety of one commonly used vegf inhibitor, bevacizumab (avastin, genentech), as a topical agent for the treatment of corneal neovascularization.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age * clinically stable corneal neovascularization * superficial or deep corneal neovascularization that extends farther than 2mm from the limbus * ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits. clinical stability - all of the following criterial should be excluded before a corneal neovascularization can be regarded as clinically stable: * current or recent (\<3 months) episode of corneal and ocular surface infection (bacterial, viral, fungal, or acanthamoebal) * recent (\<3 months) ocular surgery, including cataract surgery, and/or laser of any type in the study eye * recent (\<6 months) full thickness or lamellar keratoplasty * recent (\<6 months) ocular surface reconstruction, limbal auto or allograft stem cell transplantation, or amniotic membrane transplantation * current or recent (\<3 months) use of contact lens or plan to use contact lens (excluding bandage contact lens) * current or recent (\<3 months) persistent corneal epithelial defect (of at leat 14 days duration) measuring more than 1mm2 exclusion criteria: * current or recent (\<1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye * current or recent (\<3 months) intravitreal durg injection to the study eye. * recent (\<1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents * uncontrolled hypertension defined as systolic blood pressure \>150 mmhg or diastolic blood pressure of \>90 mmhg * history of a thromboembolic event, including myocardial infarction or cerebral vascular accident * patients age 75 or older * history of renal abnormalities * recent (\<3 months) or planned surgery * history of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin or similar anticoagulant agent) * all female patients of childbearing potential will be excluded. a female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries. * any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study. * any condition that precludes the patient's ability or an assisting family member's ability to apply the medication drops or to sustain five minutes of pressure on the lacrimal ducts after drop application. * concurrent enrollment in another clinical investigation medicinal product or device study is prohibited.
a study of risk factors for venous ulceration in patients with varicose veins of lower extremities.

Conditions: Venous Ulceration

Summary: varicose veins of lower extremities can lead to adverse consequences such as ulceration and hemorrhage, which seriously endangering the physical and mental health and quality of life for patients. the aim of this study is to explore the potential risk factors of venous ulceration in patients with varicose veins of lower extremities based on a case-control study, and to provide a reference for personalized treatment.

varicose veins of lower extremities are common chronic diseases. the main clinical manifestations are lower extremity weakness, heaviness, burning sensation, itching, swelling or pain, and severe cases are often accompanied by complications such as changes in skin color, ulceration and hemorrhage. venous ulceration is one of the main complications of lower extremity varicose veins, accounting for more than 75% of all lower extremity ulcers. venous ulceration are difficult to heal and prone to recurrence. studies have shown that the recurrence rate of venous ulceration is as high as 67%. the refractory and high recurrence rate of venous ulceration not only have a serious impact on the quality of patients' life, but also bring a heavy economic burden on society. venous ulceration in varicose veins of lower extremities patients may linked to different causes, including past medical history, comorbidity, inflammatory response, etc. the purpose of this study is to collect demographic characteristics, lifestyle characteristics, laboratory indicators, past history, comorbidity and other information by using the data set of patients with varicose veins of lower extremities based on the shandong provincial qianfoshan hospital healthcare big data platform. to explore the potential risk factors of venous ulceration in patients with varicose veins of lower extremities through case-control study.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of varicose veins of the lower extremities 2. hospitalized patients 3. 18 years old or older exclusion criteria: 1. patients with any other conditions that could also lead to venous ulceration including peripheral artery disease, diabetes, and pressure ulcers 2. patients with heart, liver and kidney failure 3. patients with malignant tumor

Keywords: varicose veins varicose ulcer leg ulcer case-control study
home exercise intervention in childhood obesity

Conditions: Child Obesity

Summary: aim: to evaluate the impact of a physical exercise web-based program with or without support on body composition, physical fitness and blood pressure values. design: randomized controlled trial. population: obese children and adolescents.

in recent years there has been a decline in levels of physical activity (pa) in both children and adults. the promotion of pa is also a key element in the treatment of obesity, along with changing eating habits, but usually has very low levels of adherence. active video games may be an alternative for the promotion of pa in the treatment of obesity. the objective of this project is to evaluate the impact of a physical exercise web-based program with or without support on body composition, physical fitness and blood pressure values.

Eligibility criteria:
inclusion criteria: * overweight or obese children and adolescents exclusion criteria: * secondary obesity syndromes * severe obesity (z score \> 2.5)

Keywords: exercise web-based intervention
microinvasive pars plana vitrectomy combined ilm peeling versus anti-vegf intravitreal injection for treatment-naïve diabetic macular edema

Conditions: Diabetic Macular Edema; Pars Plana Vitrectomy; Conbercept

Summary: diabetic macular edema (dme) is the main cause of vision loss in patients with diabetes. at present, anti-vascular endothelial growth factor (vegf) intravitreal injection is the first-line therapy for dme, nevertheless, some patients do not respond well to anti-vegf agents and often require multiple injections, which increases the psychological and economic burden of patients. microinvasive pars plana vitrectomy (ppv) has been proven to be safe and effective for refractory dme. however, there are few studies on treatment-naïve dme. the purpose of this study is to explore whether early ppv combined with internal limiting membrane (ilm) peeling can reduce the treatment burden of dme patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * patients and their families fully understand the research and sign the informed consent form * diagnosed with type 1 or 2 diabetes mellitus * hemoglobin a1c (hba1c) of less than 10% within 3 months * clear media for adequate oct and optical coherence tomography angiography (octa) images * treatment-naïve dme diagnosed clinically * central subfield thickness (cst) of \>300μm and intra- or subretinal fluid seen on (spectral-domain) sd-oct * early treatment diabetic retinopathy study (etdrs) bcva between 24 and 73 letters on the day of randomization * treatment within 12 months of dme diagnosis * no contraindication of vitrectomy or conbercept intravitreal injection exclusion criteria: * any previous dme treatment (i.e. anti-vegf injections, intraocular corticosteroids, macular photocoagulation) * macular edema caused by other disease (i.e. neovascular age-related macular degeneration, retinal vein occlusion, uveitis) * any previous intraocular surgeries (cataract surgery performed at least 3 months before study entry will not be exclusionary) * vision loss caused by other ocular disease (i.e. cataract, proliferative diabetic retinopathy, glaucoma, high myopia) * a follow-up duration of less than 12 months * severe dysfunction of the heart, liver, kidney, lung and other organs
safety study of hbv dna vaccine to treat patients with chronic hepatitis b infection

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. the study will also test the ability of vaccine to reduce hepatitis b disease.

hepatitis b virus (hbv) is responsible for the most common form of parenterally transmitted viral hepatitis. it is estimated that approximately 350 million people worldwide are persistent carriers of the virus and it is a major cause of acute and chronic infections of the liver, with significant associated morbidity and mortality. chronic infection occurs in 98% of new-born children infected by vertical transmission from the mother and in 5% of individuals infected after 2 years of age. about 25% of these subjects will progress to cirrhosis and 20% of this subgroup will develop hepatocellular carcinoma - one of the most common cancers world wide. hbv is a non-cytopathic virus and liver injury is mainly mediated by the host immune response against virus-infected liver cells and by the production of inflammatory cytokines. a vigorous, polyclonal and multispecific cytotoxic and helper t cell response to hbv is readily detectable in the peripheral blood of subjects with acute self-limited hepatitis b, but is weak, antigenically restricted (mono- or oligospecific) or undetectable in subjects with chronic infection. a vigorous t cell response is thus believed to be responsible for the elimination of the hepatitis b virus. the aim of a therapeutic vaccine would be to enhance natural responses by boosting the appropriate cellular immune response to hbv. the purpose of this study is to evaluate the safety and tolerability profile of the ppdpsc18 dna vaccine as administered by particle mediated epidermal delivery (pmed )

Eligibility criteria:
otherwise healthy, treatment naïve subjects with chronic well compensated, eag positive hbv infection

Keywords: dna vaccine immunotherapy hepatitis b virus particle mediated epidermal delivery
clinical comparison of two daily disposable contact lenses in a population of daily disposable contact lens wearers

Conditions: Myopia

Summary: the purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.


Eligibility criteria:
inclusion criteria: * currently wearing daily disposable lenses in daily wear, daily disposable modality, except dailies aquacomfort plus and 1-day acuvue trueye. * able to wear study lenses in the available powers from -1.00d to -6.00d. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * eye injury within twelve weeks of enrollment. * history of corneal or refractive surgery. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in any clinical trial. * currently wearing dailies aquacomfort plus or 1-day acuvue trueye lenses. * monovision correction during the study. * other protocol-defined inclusion/exclusion criteria may apply.
risk factors for recurrent urinary tract infection in children

Conditions: Urinary Tract Infection; Pyelonephritis; Cystitis

Summary: the purpose of this study is to determine clinical and urodynamic risk factors for recurrent urinary tract infection in 5-18 years old children.

it is known, that in the group of young children the most common reason of recurrent uti is anatomic abnormalities, such as vesicoureteral reflux, hydronephrosis. however, not all recurrent uti can be explained by anatomic abnormalities. the vast majority of school age children with recurrent uti have anatomically normal urinary tract. recent studies discuss about the role of behavioral and functional abnormalities (inadequate fluid intake, stool retention, infrequent voiding, etc.) that can predispose recurrent urinary tract infections. influence of some these abnormalities for recurrent uti is controversial. family history, behavioral and functional abnormalities which predispose to urinary tract infections in children with normal urinary tract are neglected in most protocols of urinary tract infection. children in this study receive a careful evaluation including complete history, voiding-drinking diary, bowel questionnaire, physical investigation, sonography, voiding cystourethrogram. follow up time - 1 year. urinalysis once a month and during each episode of fever.

Eligibility criteria:
inclusion criteria: * 5-18 years old children, who were treated because of cystitis and pyelonephritis in kaunas medical university hospital exclusion criteria: * urinary tract malformations * neurogenic bladder dysfunction * patients, who received immunosuppressive drugs * pregnant girls * children with non bacterial urinary tract infection

Keywords: pyelonephritis cystitis risk factor children urodynamics
hiit vs hrv-based training for rehabilitation after stroke

Conditions: Stroke; Cardiac Disease; Ischemic Stroke; Ischemic Heart Disease; Stroke, Ischemic

Summary: consequences of stroke are manyfold but all of them are important factors on the long-term outcomes of rehabilitation, becoming an important health problem with requires health strategies with advanced age. high intensity interval training (hiit) is an efficient training protocol used in cardiac rehabilitation programs, but owing to the inter-individual variability in physiological responses to training associated to cardiovascular diseases, the exercise dose received by each patient should be closely controlled and individualized to ensure the safety and efficiency of the exercise program. the heart rate variability (hrv) is actually being used for this purpose, as it is closely linked to de parasympathetic nervous system activation. in this way, higher scores in hrv are associated with a good cardiovascular adaptation. the objective of this protocol is to determine the effect of hiit compared with hrv-guided training on cardiorespiratory fitness, heart rate variability, functional parameters, body composition, quality of life, inflammatory markers, cognitive function, and feasibility, safety and adherence in patients after stroke undertaking an 8-week cardiac rehabilitation program. this will be a cluster-randomized controlled protocol in which patients after stroke will be assigned to an hrv-based training group (hrv-g) or a hiit-based training group (hiit-g). hiit-g will train according to a predefined training program. hrv-g training will depend on the patients' daily hrv. the peak oxygen uptake (vo2peak), endothelial and work parameters, the heart rate variability, the functional parameters, the relative weight and body fat distribution, the quality of life, the inflammatory markers, the cognitive function, and the exercise adherence, feasibility and safety will be considered as the outcomes. it is expected that this hrv-guided training protocol will improve functional performance in the patients after stroke, being more safe, feasible and generating more adherence than hiit, providing a better strategy to optimize the cardiac rehabilitation interventions.


Eligibility criteria:
inclusion criteria: * left ejection fraction higher than 30% after stroke * aged between 18 and 80 years old exclusion criteria: * presence of absolute or relative contraindications for accomplishing the treadmill test, indicated by the spanish society of cardiology * being treated for other diseases, or regularly taking a drug(s) that has a direct or indirect effect on the nervous system (e.g., anxiolytics, antidepressants or neuroleptics) * absence of medication to control the cardiovascular disease or its modification during the intervention * people who are participating or have participated in the previous three months in other similar exercise programs * not performing at least 80% of the workouts during the intervention

Keywords: heart rate variability hiit cardiac rehabilitation safety adherence vo2peak
ldh as a biochemical biomarker to predict organ failure in the emergency department setting

Conditions: Multiple Organ Failure

Summary: the purpose of this study is evaluate if k3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as sofa score. k3 consists of lactate dehydrogenase, albumin and magnesium combined.


Eligibility criteria:
inclusion criteria: * age ≥18 years * admitted to emergency department, karlstad central hospital, sweden exclusion criteria: * not in need of venous blood sample