Kornimate/medical-research-clean huggingface dataset:
abdominal skeletal muscle compartments in turkish children

Conditions: Child Development; Sarcopenia

Summary: the aim of this study was to establish reference values for three compartments of the abdominal skeletal muscle area (psoas muscle area, paraspinal muscle area, and total skeletal muscle area) obtained from cross-sectional computed tomography images in turkish children

the aim in this study is to determine reference values for turkish children by evaluating the abdominal region skeletal muscle area (psoas muscle, paraspinal muscles and total skeletal muscle in the section) obtained from cross-sectional ct images. material method of the research the study was planned as a retrospective study. patients under 18 years of age who are admitted to istanbul province bağcılar training and research hospital with acute abdominal pain or acute trauma between may 5, 2017 and may 5, 2023 and who underwent abdominal computed tomography (ct) imaging on this date of application will be scanned through the hospital information management system. past diagnoses of these patients will be questioned and those with chronic diseases will be excluded from the study. ct images of the patients will be retrieved from the pacs database. from the sections taken at the l3-l4, l4-l5 levels, the cross-sectional area of the psoas muscle, paraspinal muscles and the total skeletal muscles in that section will be measured using the hospital's synaps system. the results will be recorded in cm2.

Eligibility criteria:
inclusion criteria: * no chronic disease * being under 18 years of age * being turkish * determining that an abdominal ct was performed in the hospital records exclusion criteria: * patients with malignancy or known chronic disease * patients with mental health problems

Keywords: children abdominal skeletal muscle sarcopenia
robot assisted gait training in patients with infratentorial stroke

Conditions: Stroke

Summary: the effect of robot assisted gait training in patients with infratentorial stroke

the hypothesis is to determine the robotic gait training would be better than conventional therapy regarding the postural balance.

Eligibility criteria:
inclusion criteria: * patients with infratentorial stroke * cognitively intact enough to understand and follow the instructions from the investigator exclusion criteria: * chronic neurological pathology * orthopedic injuries * femur lengths of less than 34cm * severely limited range of lower extremity joint motion * medical instability

Keywords: infratentorial stroke robot postural balance rehabilitation
a follow up study to determine the safety and tolerability of sub-retinal transplantation of human embryonic stem cell derived retinal pigmented epithelial (hesc-rpe) cells in patients with stargardt's macular dystrophy (smd)

Conditions: Stargardt's Macular Dystrophy

Summary: the purpose of this study is to evaluate the long term safety and tolerability of hesc-rpe cellular therapy in patients with advanced smd from 1 to 5 years following the surgical procedure to implant the hesc-rpe cells.

this study is a long-term, follow- up of a phase i/ii, open-label, non-randomized, 4-cohort, dose escalation, multi-center clinical trial (referred to as the core trial or core protocol) in which a maximum of 12 smd patients were transplanted with sequential doses of hesc-rpe cells, starting at a dose of 50,000 hesc-rpe cells transplanted and increasing to a maximum dose of 200,000 hesc-rpe cells transplanted. all patients who participate in the core protocol are eligible for participation in the follow-up protocol. the first visit of this extension protocol will correspond to the last visit of the core protocol, and will take place at 12 months post-cell implantation. informed consent for this follow-up protocol will be obtained at the first visit which will occur at the 12-month visit of the core protocol. patients will be evaluated at 18, 24, 36, 48 and 60 months post-transplant (or more frequently as clinically indicated). follow-up will include obtaining information about ophthalmological findings and events of special interest as defined in the primary outcome. at the last visit of this follow up study, whether at 60 months post-transplant or at early discontinuation, patients will be invited to participate in a life-long annual health survey, under a separate protocol, to further monitor long-term safety.

Eligibility criteria:
inclusion criteria: * must have been treated with hesc-rpe cell transplant in the core protocol. * able to understand and willing to sign the informed consent to participate in the follow-up study. exclusion criteria: * there are no exclusion criteria

Keywords: stargardt's macular dystrophy retinal diseases macular degeneration fundus flavimaculatus hesc-rpe asp7316 juvenile macular dystrophy smd
influence of age, weight and ethnic background on blood pressure

Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension

Summary: hypertension, also known as high blood pressure, is a chronic medical condition, in which the blood pressure is elevated. this is a common condition, which can lead to severe complications such as cardiovascular disease, heart attack, stroke and kidney disease, if not detected and treated early. accumulating evidence suggests that the incidence of hypertension varies according to age, ethnicity and obesity. in order to obtain an in-depth knowledge of the pathophysiological mechanisms of hypertension, we aim to investigate the haemodynamic and biochemical correlates of elevated blood pressure across the adult age-span, and determine the extent to which body size and ethnicity impact on these associations. we also wish to investigate the impact of hypertension on key target organs (end-organ damage). the primary objective of this study is to compare the mechanisms regulating blood pressure in hypertensive and non-hypertensive participants across the adult age span, and to assess the influence of body mass index and ethnic background on these mechanisms. secondary objectives are to investigate the association between blood pressure and cardiovascular physiology across the adult age span at rest and during sub-maximal exercise and to investigate the impact of blood pressure haemodynamics on key organs including the arteries and heart by assessing end-organ damage such as endothelial function, arterial structure and left ventricular mass/function. this study will be a combined case-control and cross-sectional study describing the procedures and time commitment required to investigate our scientific aims. this is a single centre study that will be conducted in a secondary care environment. both male and females aged 18 and over and that are able provide informed consent will be considered for this study. people who are pregnant, currently receiving dialysis, illness with a life expectancy \<1 year, current active malignancy and cannot provide informed consent are ineligible for this study. the study will be open for five years and each patient will complete a maximum of four visits in a 12 month period. participants will complete a variety of non-invasive physiological assessments of their cardiovascular system and lung function. there will be some minimally invasive procedures completed, including a blood test and assessment of small artery endothelial function which involves insertion of a small needle under local anesthetic.


Eligibility criteria:
inclusion criteria: * male or female, aged 18 or above * able to give informed consent and willing to participate exclusion criteria: * pregnancy * current active malignancy * currently receiving dialysis * any illness with a life expectancy \< 1 year * lack of written informed consent

Keywords: epidemiology ethnicity age weight hypertensive cardiac output peripheral vascular resistance arterial stiffness healthy volunteers endothelial function arterial structure left ventricular mass/function
time aspirin: chronotherapy with aspirin for reduction of cardiovascular disease

Conditions: Cardiovascular Diseases

Summary: this study will be a comparative effectiveness research to determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after awakening and aspirin before bedtime.

aspirin is the cornerstone of preventive cardiovascular disease (cvd) treatment and bedtime intake of aspirin (chronotherapy) has been shown to reduce morning activity of platelets. it has been shown that platelet reactivity follows a clear circadian rhythm, with a peak of platelet reactivity during the morning (6-12 am). importantly, studies have shown in meta-analyses that high platelet activity is predictive of adverse cardiovascular outcomes in patients with stable cvd. given this knowledge, it is highly likely that the morning peak of platelet reactivity contributes to the morning peak of cardiovascular events and that reduction of morning platelet activity prevents cardiovascular events during morning hours. this may be achieved by intake of aspirin at bedtime instead of on awakening. this study will be a comparative effectiveness research to determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after awakening and aspirin before bedtime.

Eligibility criteria:
inclusion criteria: * use of low-dose aspirin (acetylsalicylic acid 80mg \[brand name: acetylsalicylic acid cardio teva\]\~) * patients using aspirin from an mdd ('baxter') * capacity to give informed consent (ic) exclusion criteria: * pregnancy * mental or physical disability to fulfil study requirements * insufficient knowledge of the dutch language * patients currently participating in another (clinical) trial or study

Keywords: aspirin chronotherapy
efficacy, safety and tolerability of topically applied lde225 cream (hedgehog pathway inhibitor) in adult patients with nevoid basal cell carcinoma syndrome (nbccs)

Conditions: Basal Cell Carcinoma

Summary: this 22 week study will assess the efficacy, safety, and tolerability of lde225 versus vehicle when applied topically to basal cell carcinoma (bcc) in patients with nbccs. patients will treat multiple bccs for up to 12 weeks. treatment success is defined as complete clinical clearance and complete histological clearance in bccs.


Eligibility criteria:
inclusion criteria: 1. adult greater than 18 years old, male or female. 2. patient must be able to understand and communicate with the investigator and comply with the requirements of the study. 3. typical presentation of nbccs in the opinion of the investigator 4. at least one of the major clinical criteria of nbccs. 5. multiple bccs during the screening period exclusion criteria: 1. any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator. 2. prior exposure to lde225. 3. use of systemic treatment for bcc in the 4 weeks prior to baseline. 4. use of topical treatment or photodynamic therapy (pdt) in the 12 weeks prior to baseline. 5. use of other investigational drugs at baseline, or within 30 days or 5 half-lives prior to baseline, whichever is longer. 6. clinically significant medical condition, as per judgment of the investigator. 7. history of hypersensitivity to any of the ingredient of the study drug. 8. pregnant or nursing (lactating) women 9. women of child-bearing potential and fertile males, unless they are using two birth control methods other protocol-defined inclusion/exclusion criteria may apply

Keywords: basal cell carcinoma nevoid basal cell carcinoma syndrome nbccs, gorlin syndrome gorlin-goltz syndrome basal cell nevus syndrome bcns, hedgehog pathway inhibitor topical smoothened
asthma (and dietary) inflammation reduction

Conditions: Asthma

Summary: the purpose of this study is to evaluate the effects of a diet that is low in glycemic load and abundant in fiber, fruits, vegetables, legumes and omega-3 fatty acids ("anti-inflammatory diet") on pulmonary function in pediatric patients with asthma. the primary endpoint will be change in forced expiratory volume in one second in response to the diet intervention. secondary outcomes will include additional spirometry measures, fraction of exhaled nitric oxide, and assessment of symptomatic asthma control. in addition, we will identify potential physiological mechanisms relating diet with lung function, including changes in systemic inflammation, insulin sensitivity, and intestinal microbiome composition.

asthma, an inflammatory disease of the airway mucosa, is highly correlated with obesity and nutritional intake in multiple cross-sectional studies. limited interventional data in adults with asthma, relying on behavioral modification, have reported that asthma control significantly improves with caloric restriction and diets enriched with antioxidants, and may improve with increasing omega-3 fatty acid content. a comprehensive diet harnessing anti-inflammatory properties of multiple foods may have synergistic effects on bronchial inflammation and pulmonary function, yet this possibility remains largely untested, especially in children. we propose a randomized, controlled cross-over trial, with 6-week treatment arms, in pediatric patients with moderate to severe asthma. the experimental diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content. the comparison diet will be each participant's habitual diet. both diets will be isocaloric and weight maintaining, to isolate the effects of the dietary composition from the known beneficial effects of weight loss. in addition, the home delivery of prepared meals will alleviate the variable and incomplete adherence commonly observed in behavioral studies.

Eligibility criteria:
inclusion criteria: * age 10-21 years * clinical diagnosis of moderate or severe persistent asthma * currently prescribed inhaled corticosteroids for asthma with anticipated stable dosing regimen for the duration of the study * admission to boston children's hospital for clinical asthma exacerbation * medical clearance from primary care provider * willingness to comply with study diet exclusion criteria: * body mass index (bmi) \< 3rd centile (age- and gender- adjusted normative range from center for disease control) * known eating disorder * celiac disease * any food allergy * any other major illness as assessed by medical history or the following screening tests: * alanine aminotransferase (alt) \> twice upper limit of normal for age * creatinine \> 1.0 mg/dl for age 10-18 years; \> 1.2 mg/dl for females \> 18 years; or \> 1.4 mg/dl for males \> 18 years) * random glucose \> 200 mg/dl * hemoglobin \ 18 years; or \ 18 years * use of systemic steroids for indication other than asthma

Keywords: asthma nutrition anti-inflammatory diet
pre-operative effects of mifepristone on dilation and evacuation services

Conditions: Legally Induced Abortion Without Mention of Complication

Summary: this research study investigates the use of a drug, mifepristone, given before second trimester abortion. mifepristone is a medication that is approved for medical abortion during the first trimester. it also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). this medication has effects on the uterus that may help dilate, or open, the cervix. abortion requires opening of the cervix to safely remove the pregnancy. cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. these complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. these rods then absorb the moisture of the vagina and slowly expand, opening the cervix. the standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. this procedure can be uncomfortable. a prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. we aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.


Eligibility criteria:
inclusion criteria: * \>18 years old * viable, singleton pregnancy * voluntarily seeking abortion between 19 and 24 wks gestation * able to give informed consent and comply with study protocol * fluent in english or spanish exclusion criteria: * allergy to misoprostol or mifepristone

Keywords: induced abortion mifepristone dilation and evacuation cervical preparation osmotic dilators
a phase iiib study to compare the efficacy and safety of concomitant treatment in patients with copd

Conditions: COPD

Summary: the purpose of this study is to evaluate the safety and efficacy of the concomitant treatment of formoterol fumarate with tiotropium bromide compared to treatment with tiotropium bromide alone.


Eligibility criteria:
inclusion criteria: * medical diagnosis of copd * current or prior history of cigarette smoking exclusion criteria: * medical diagnosis of asthma * significant condition or disease other than copd

Keywords: copd formoterol tiotropium
wavelight® ex500 excimer laser system for the correction of myopia using innoveyes™ in conjunction with innoveyes™ sightmap

Conditions: Myopia

Summary: the purpose of this study is to evaluate the safety and effectiveness of the wavelight ex500 excimer laser system for the correction of myopia with and without astigmatism using innoveyes in conjunction with innoveyes sightmap.

qualified subjects will receive treatment in both eyes and be followed for 1 year. subjects will be asked to attend a total of 9 visits (screening, day 0 surgery, day 1, week 1, month 1, month 3, month 6, month 9, and year 1). the primary endpoints will be assessed at refractive stability, defined as the latter of two postoperative manifest refractions performed at least 3 months apart (or at 3 months after surgery when compared with the 1-month visit) that meets all the protocol-specified stability requirements. total expected duration of subject participation is approximately 1 year. this study will be conducted in the united states.

Eligibility criteria:
key inclusion criteria: * myopia up to and including -11.00 d with or without astigmatism up to -4.50 d, with mrse no more than -12.00 d * best corrected photopic distance visual acuity of 20/20 or better * uncorrected photopic distance visual acuity of 20/40 or worse * stable refraction (within ± 0.50 d) as determined by mrse for a minimum of 12 months prior to surgery key exclusion criteria: * history or evidence of active or inactive corneal disease or retinal vascular disease, keratoconus or glaucoma (or suspect) * previous intraocular or corneal surgery * intent to have monovision treatment other protocol-specified inclusion and exclusion criteria may apply.

Keywords: lasik ray tracing myopia astigmatism
a study of a remediation program of social cognition in schizophrenia

Conditions: Schizophrenia

Summary: theory of mind (ability to infer others' intention, emotion, etc) is known to be altered in patients with schizophrenia and its deficit to be correlated with their decreased social proficiency. we designed a novel cognitive therapy, that makes use of videos, aimed at learning a better use of contextual information to infer others' intentions. the aim of this study is to demonstrate, in schizophrenic patients, a quantitative improvement of their ability to infer intention of others induced by this novel training program. a secondary aim is to measure the cerebral correlates (meg, pev) of this social cognitive function and of its anticipated improvement.

scientific justification : improvement by training has been demonstrated in schizophrenic patients for various cognitive functions and skills, though not yet for the social cognition ability specifically dedicated to infer others' intention when not explicit. main hypothesis : abilities to infer other's intention can improve in schizophrenic patients following specific practice. primary aim : to demonstrate this improvement, as quantified by improvement of v-sir scores (v-lis scores in french literature). procedure : ten weekly sessions of a novel cognitive therapy that makes use of videos aimed at learning a better use of contextual information to infer others' intentions. group of 5 patients trained by 2 therapists. comparison with a non-cognitive psycho-educational training (same organisational design). study design : controlled randomized simple blind study (equivalent to a phase iib therapeutic trial). matched pair design. 40 patients (20 per arm).

Eligibility criteria:
inclusion criteria: * schizophrenia following dsm iv; * age 18-57; * stability of the clinical state; * ability to learn; * deficit in intention reading as measure with the v-sir (v-lis in french) test (score \>13); * informed consent to participate to the study. exclusion criteria: * any other organic or neuropsychiatric disease

Keywords: schizophrenia social cognition theory of mind cognitive therapy therapeutic trial magnetoencephalography (meg)
biomarkers to predict cancer therapy-related cardiotoxicity

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Summary: this study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy.

primary objective: i. to collect biospecimens from 1) patients who developed chemotherapy related cardiac toxicity (crct) and 2) patients who are at a high risk for developing crct. outline: this is an observational study. patients undergo blood sample collection and have their medical records reviewed on study.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy * one of the following: * diagnosed with cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment * completed chemotherapy with no cardiotoxicity at least two years post treatment * patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. this will include chemotherapy, immunotherapy, targeted therapy that have been associated with cardiac toxicity * an understanding of the protocol and its requirements, risks, and discomforts * the ability and willingness to sign an informed consent exclusion criteria: - inability on the part of the patient to understand the informed consent or be compliant with the protocol