Kornimate/medical-research-clean huggingface dataset:
global registry and natural history study for mitochondrial disorders

Conditions: Mitochondrial Diseases; Kearns-Sayre Syndrome; MIDD; SANDO; SCAE; NARP Syndrome; MELAS Syndrome; MERRF Syndrome; Coenzyme Q10 Deficiency; LHON; MNGIE; MIRAS; Barth Syndrome; MDS; Mitochondrial Myopathies; Leigh Syndrome; Pearson Syndrome; CPEO

Summary: the main goal of the project is provision of a global registry for mitochondrial disorders to harmonize previous national registries, enable world-wide participation and facilitate natural history studies, definition of outcome measures and conduction of clinical trials.

the global mitochondrial registry and natural history study is part of the eu-financed genomit project, co-ordinated by dr. holger prokisch, technische universität münchen (tum).it aims at advancing the understanding of the natural history of mitochondrial disease to inform the design and facilitate the conduction of clinical trials. it also serves as a catalyst for translating basic research results into clinical practice. the global mitochondrial registry and natural history study provides for all contingencies of national ethics and data protection rules including data access management. currently participating networks are: * german network for mitochondrial diseases - mitonet, germany/austria * italian registry of mitochondrial patients - mitocon, italy the inclusion of other networks and countries is possible and explicitly welcome. a major advantage of the global registry is that countries can join in, saving a lot of time, effort and funding.

Eligibility criteria:
inclusion criteria: * suspected or confirmed mitochondrial disease * willingness to participate exclusion criteria: * unwillingness to participate

Keywords: patient registry
shared decision-making for the promotion of patient-centered imaging in the ed: suspected kidney stones

Conditions: Shared Decision-making; Kidney Stone; Emergencies; Radiation Exposure; Communication

Summary: although a ct scan is required for some emergency department patients with signs and symptoms of a kidney stone, recent evidence has shown that routine scanning is unnecessary and may expose young patients to significant cumulative radiation, increasing their risk of future cancers. shared decision-making may facilitate diagnostic imaging decisions that are more inline with patients' values and preferences. by comparing a shared approach to diagnostic decision-making to a traditional, physician-directed approach, this study lays the foundation for a future randomized trial that will reduce radiation exposure, improve engagement, and improve the quality and patient-centeredness of emergency department care.


Eligibility criteria:
inclusion criteria: 1. age 18-55, 2. with acute flank pain - for whom clinician believes acute flank pain may be from renal colic 3. who are deemed by the treating clinician to be at low risk for dangerous alternative diagnoses. 4. clinician is considering imaging patient for kidney stones (any imaging) exclusion criteria: 1. recent trauma related to pain (including minor such as lifting/turning) 2. pregnancy (previous or discovered during ed visit) 3. recent surgical procedure on abdomen or pelvis (30d) 4. recent urologic procedure (30d) 5. recent childbirth (30d) 6. signs of systemic infection: fever \>100.9 (101 and up), sbp \ 120 7. moderate or severe abdominal tenderness or rebound/guarding, consistently present (present for more than one exam, or present after patient treated with pain medication) 8. second doctor's visit (ed, pcp, urgent care) for this episode of pain (previous similar visits ok if pain gone for \>30d in between episodes) (if seen at pcp or urgent care in same day or 24 hour period, this is not an exclusion, but if seen at pcp/urgent care or ed 1-30 days prior to index visit, with same pain, excluded) 9. known history of one kidney or other urological/renal abnormality (including neurogenic bladder, esrd and paraplegia; or if solitary kidney discovered on us) 10. known malignancy (any) within past year (or received treatment in the past 12 months) 11. immunocompromised (chronic steroids, hiv, crohns, immunomodulators or severely ill chronically) 12. on anticoagulation 13. crisis patient (behavioral health)/belligerent 14. lacks capacity for medical decision-making 15. unlikely to respond to follow-up calls (ivda, homeless, no phone) 16. clinician is concerned for alternative diagnosis requiring ct scan (appendicitis) (\>5% likelihood by clinician gestalt) 17. patient is not improving clinically and clinician is considering admission
correlation between sv2a expression in tumour tissue and efficacy of levetiracetam in glioma patients with epilepsy

Conditions: Epilepsy; Glioma

Summary: the purpose of this study is to investigate the correlation of sv2a expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

levetiracetam is a relatively novel anti-epileptic drug (aed), which has proven to be effective and well tolerated in many glioma patients with otherwise pharmacoresistant epilepsy. moreover, levetiracetam has neither enzyme-inducing nor enzyme-inhibiting properties, which makes the drug particularly attractive for brain tumour patients, as they frequently receive chemotherapy and/or corticosteroids. therefore, levetiracetam is the anti-epileptic drug of choice post-operatively in glioma patients suffering from epilepsy. unfortunately, even with levetiracetam, a proportion of glioma patients is not free of seizures. it is unclear, however, which glioma patients benefit from levetiracetam treatment. it is suggested that the expression of protein sv2a is correlated with clinical response to levetiracetam. the determination of sv2a expression in brain (tumour) tissue might be used as a predictive tool for response to levetiracetam. objective of this study: correlation of sv2a expression in surgically removed tumour and tumour-surrounding tissue of glioma patients suffering from epilepsy with their clinical response to levetiracetam.

Eligibility criteria:
inclusion criteria: * age \> 18 years * suffering from partial seizures, with or without secondary generalisation * must have undergone surgery for their newly diagnosed or recurrent glioma not more than 42 days previously * treated with levetiracetam * histologically proven astrocytoma grade ii or iii, oligodendroglioma grade ii or iii, oligoastrocytoma grade ii or iii, or glioblastoma multiforme according to the world health organisation (who) classification of tumours affecting the central nervous system * written informed consent exclusion criteria: * women who are pregnant or lactating * patients who do not have a basic proficiency of the dutch language,or are unable to communicate adequately will also be excluded.

Keywords: epilepsy glioma
vitamin d supplements on markers for cardiovascular disease and diabetes: an individual participant data meta-analysis

Conditions: Vitamin D Deficiency; Vitamin; Excess Vitamin D (Nutritional)

Summary: this meta-analysis will be conducted to study the effect on vitamin d supplements on markers for cardiovascular disease and diabetes using individual participant data from 12 rcts. given that previous data suggest that vitamin d supplementation might be most effective in those individuals with very low 25-hydroxyvitamin d (25(oh)d) and potentially harmful in those achieving very high levels after vitamin d supplementation, this meta-analyses will be performed in subgroups according 25(oh)d levels.

large randomized controlled trials (rcts) are currently on-going to evaluate non-skeletal effects of vitamin d supplementation in the general older population. the results of these studies can be expected in 2017 to 2020 and while they will report important data, they may still leave knowledge gaps on the effects of vitamin d on clinically relevant surrogate parameters in specific groups. recent data indicate that the association of vitamin d status and outcome is u- or reverse j-shaped and may be modified by the presence of certain risk factors or genetic variations of the vitamin d receptor. this work is part of the european union-project 'food-based solutions for eradication of vitamin d deficiency and health promotion throughout the life cycle' (odin). this individual patient meta-analysis of existing high quality vitamin d rcts aims to evaluate whether there are beneficial or harmful vitamin d effects on surrogate parameters for clinical outcomes (i.e. blood pressure, lipids, parathyroid hormone (pth), fasting blood glucose and glycated haemoglobin (hba1c)). with data from almost 3000 randomized subjects from 12 rcts that are available within this consortium, the investigators will have sufficient power to detect clinically relevant effects of vitamin d supplementation on risk factors for cardiovascular disease. subgroup analyses will investigate effect modifiers to evaluate whether certain groups of individuals experience pronounced or attenuated effects from vitamin d supplementation. given that previous data suggest that vitamin d supplementation might be most effective in those individuals with very low 25(oh)d and potentially harmful in those achieving very high levels after vitamin d supplementation, this individual patient data meta-analyses will be performed in subgroups with serum 25(oh)d levels \ 100, 125 and 150 nmol/l. 25(oh)d levels will be re-measured to ensure comparability.

Eligibility criteria:
inclusion criteria: * availability of quality bio-banked samples for uniform 25(oh)d re-measurement * prospective data on one or more of the outcomes * willingness to collaborate exclusion criteria: * trials among pregnant women, children, or performed in patient populations.

Keywords: odin meta-analysis cholecalciferol 25(oh)d subgroup effects
early term delivery versus expectant management of the large for gestational age fetus

Conditions: Macrosomia, Fetal; Labor Induction

Summary: the purpose of this study is to compare the incidence of composite neonatal morbidity and birthweight \>4500 grams among uncomplicated large for gestational age (lga) fetal growth at delivered 37 weeks versus expectant management.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * plan for vaginal delivery. patients with prior cesarean section are eligible if they are planning for a trial of labor after cesarean section. * gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment * dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound \<21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization * no known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician) * lga defined as estimated fetal weight (efw) \> 90th percentile by hadlock formula but \<4500 grams exclusion criteria: * pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin) * planned cesarean delivery * polyhydramnios * known major fetal anomalies * multiple gestation or selective reduction of multiple gestation after 14 weeks * previous stillbirth at term * indications for delivery at \<39 weeks. common examples include: * placenta previa * placenta accreta * vasa previa * history of classical cesarean section or myomectomy * human immunodeficiency virus (hiv) * oligohydramnios (low amniotic fluid, defined as maximum vertical pocket \<2.0cm) * high-risk pregnancy as determined by the physician. common examples include: * pre-gestational diabetes or gestational diabetes on medication * chronic hypertension on medication * maternal cardiac disease * asthma requiring oral steroids during pregnancy * chronic renal disease * antiphospholipid syndrome * hyperthyroidism * prior stillbirth * systemic lupus erythematous * hemoglobinopathies such as sickle cell disease

Keywords: large for gestational age fetal growth
a non-randomized, open-label study to evaluate the safety and effectiveness of dayspring active wearable compression technology for treating lower extremity lymphedema

Conditions: Lymphedema; Lymphedema Lower Extremity; Chronic Venous Insufficiency; Secondary Lymphedema

Summary: a non-randomized, open-label study to evaluate the safety and effectiveness of koya dayspring active wearable compression technology for treating lower extremity lymphedema

a non-randomized, open-label study to evaluate the safety and effectiveness of koya dayspring active wearable compression technology for treating lower extremity lymphedema

Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * willing to sign the informed consent and deemed capable of following the study protocol * subjects must have a diagnosis of primary or secondary unilateral lower extremity edema * at the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable exclusion criteria: * individuals with a history or presence of an acute systemic disorder or condition that could place the patient at increased risk from sequential compression therapy * inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device * diagnosis of lipedema * diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer) * diagnosis of acute infection (in the last four weeks) * diagnosis of acute thrombophlebitis (in last 6 months) * diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * diagnosis of pulmonary edema * diagnosis of congestive heart failure (uncontrolled) * diagnosis of chronic kidney disease with acute renal failure * diagnosis of epilepsy * patients with poorly controlled asthma * any condition where increased venous and lymphatic return is undesirable * women who are pregnant, planning a pregnancy or nursing at study entry * participation in any clinical trial of an investigational substance or device during the past 30 days
mk0431a vs. pioglitazone in patients with type 2 diabetes mellitus (0431a-066)

Conditions: Type 2 Diabetes Mellitus

Summary: a study to evaluate the efficacy and safety of mk0431a in comparison to a commonly used medication in patients with type 2 diabetes


Eligibility criteria:
general inclusion criteria: * patient has type 2 diabetes mellitus * patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy general exclusion criteria: * patient has a history of type 1 diabetes mellitus or history of ketoacidosis * patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks * patient was on \>4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
psychometric properties of the updated module on assessing quality of life of patients with breast cancer

Conditions: Breast Cancer; Quality of Life

Summary: females breast cancer is still the most frequent type of cancer in europe with 21 per 100,000 women .the eortc qlq-br23 was one of the first modules developed to be used in conjunction with the core questionnaire eortc qlq-c30 and was published in 1996. since the beginning of the work on the eortc qlq-br23 some 20 years ago, much knowledge has been gathered about the epidemiology of breast cancer, and major advances have been made with regard to diagnostic and therapeutic options. therefore, the eortc qlg decided to update the bc23. a phase 1 to 3 module development project has been completed. this resulted in a 45 item module, retaining 23 of the original items and adding 22 new items, particularly tapping into the side effects of new systemic and local therapies. the aim of the phase 4 study is to test the scale structure, reliability, responsiveness to change, and validity of the eortc qlq-bc45 in conjunction with the eortc qlq- c30 in patients diagnosed with breast cancer. participants will be enrolled in three groups according to their disease stage (1. localized disease or locally advanced disease, 2. metastatic disease, 3. follow up). various combinations of therapies are permissible, resulting in a total of 17 subgroups.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of breast cancer * no previous primary or recurrent tumour * ability to understand the language of the questionnaire * mental fitness to complete a questionnaire * 18 years of age or above * written informed consent. exclusion criteria: * no histologically confirmed diagnosis of breast cancer * previous primary or recurrent tumour * not mentally fit to complete a questionnaire * not able to understand the language of the questionnaire * younger than 18 * refusal of informed consent
an open-label safety study of oral ganciclovir maintenance treatment of cmv retinitis in people with limited venous access

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (cmv) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.

patients receive oral ganciclovir as maintenance. patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.

Eligibility criteria:
inclusion criteria patients must have: * aids. * stable cmv retinitis. * treatment with iv ganciclovir or iv foscarnet for at least 18 of the past 21 days. * no permanent central iv catheter at present. * had a permanent central iv catheter removed two or more times within the past 6 months due to catheter infection or thrombosis. * consent of guardian if less than legal age of consent. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * require continuation of concomitant medications precluded by this protocol. concurrent medication: excluded: * intravitreal anti-cmv treatment. * any other concomitant medications precluded by the protocol. patients with the following prior condition are excluded: history of hypersensitivity to acyclovir or ganciclovir.

Keywords: retinitis ganciclovir administration, oral acquired immunodeficiency syndrome
perceived barriers to exercise in individuals living with spinal cord injury

Conditions: Spinal Cord Injury

Summary: purpose: this project is designed to identify what the key barriers to participating in exercise are for the general population of people living with spinal cord injury (sci) in the united states (us).

purpose: this project is designed to identify what the key barriers to participating in exercise are for the general population of people living with spinal cord injury (sci) in the united states (us). background: a previous study of 681 people living with sci demonstrated that the majority of participants thought that exercise was important (97%), but that only 57% actually had access to exercise (k.d. anderson. 2004. targeting recovery: priorities of the spinal cord injured population. j. neurotrauma. 21:1371-1383). the next step in continuing that research is to determine in more detail what the perceived barriers to exercise are so that they can be addressed in multiple settings (research design of exercise protocols, community access and awareness, clinical effectiveness, etc.). methods: internet-based survey of people with spinal cord injuries (sci). expected results: it is expected that the perceived barriers will fall under 3 main categories (internal, resources, and structural). however, there may be other barriers we are unaware of, for example, societal or cultural factors or other factors completely unforeseen. relevance to rehabilitation: the findings of this project will provide valuable information needed to design strategies aimed at improving participation in exercise by people living with sci. sci results in several secondary health conditions over time, which can likely be positively impacted by exercise.

Eligibility criteria:
inclusion criteria: * any person with a spinal cord injury who is at least 18 years of age, lives in the united states of america, and can read english. exclusion criteria: * people who cannot read english will not be included because the website will be hosted in english and the survey software (phpquestionnaire 2.2 by chumpsoft, inc.) default language is english.

Keywords: any person with a spinal cord injury at least 18 years of age
cost evaluation of venous leg ulcers management

Conditions: Varicose Ulcer

Summary: the purpose of this study is to evaluate direct costs of venous leg ulcers (vlu) management when two different compression systems are used.

the purpose of this study is to evaluate direct costs of venous leg ulcers management when two different compression systems are used. micro-costing during the study will bring direct costs which include nurse and physician time, dressings and bandages. perspective of costs will be public health insurance. time horizon will be 16 weeks.

Eligibility criteria:
inclusion criteria: * consent to participate * ambulatory management * 1 to 3 leg ulcers * leg ulcers below the knee and above ankle * no contra-indication to wear compression bandage * not currently treated by one of the investigational devices exclusion criteria: * cognitive impairment * opposition to wear compression bandage * bedridden * pregnancy

Keywords: costs and cost analysis humans health care costs varicose ulcer compression bandages
electrical stimulation during immobilization

Conditions: Disuse Atrophy; Immobilization; Neuromuscular Electrical Stimulation

Summary: in the present study, the effects of 5 days of lower limb immobilization with or without daily neuromuscular electrical stimulation on muscle mass and muscle fiber characteristics will be determined.


Eligibility criteria:
inclusion criteria: * male * aged from 18-35 years * 18.5 \< bmi \< 30 kg/m2 exclusion criteria: * smoking * performing regular resistance training in the previous 6 months * hypertension (according to who criteria) \[46\] and/or cardiovascular disease * any back/leg/knee/shoulder complaints which may interfere with the use of crutches * use of any prescribed medication * type 2 diabetes mellitus * any family history of thrombosis * all co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis). * myocardial infarction within the last 3 years * use of anti-coagulants