Kornimate/medical-research-clean huggingface dataset:
pressure ulcer prevention study in sci

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to conduct a randomized controlled trial of a lifestyle redesign intervention's ability to (1)reduce the incidence of medically serious pressure ulcers and associated surgeries in adults with spinal cord injury, and (2)assess the intervention's cost-effectiveness and potential cost savings and its effects on participants' quality of life.

medically serious pressure ulcers are a common complication of spinal cord injury (sci), and are associated with high treatment costs and reduced quality of life. this study will examine the efficacy and cost-effectiveness of a promising lifestyle-based intervention designed to reduce the incidence of pressure ulcers among culturally diverse, community dwelling adults with sci who have had serious pressure ulcers. the intervention being tested, termed lifestyle redesign (lr), is based on prior sci literature as well as on the results of a qualitative pilot study undertaken by our study group. this intervention targets several psychosocial mediating variables that have been shown to be important in prevention of pressure ulcers in daily living contexts. participants assigned to the lr condition receive individualized in-home sessions, personal phone calls, and incident-based contacts for a 12-month period, followed by 12 months of no intervention. participants in the control condition do not receive any study-based intervention, but (along with the lr group) have continuing access to the standard options for prevention and treatment that are available through rancho los amigos national rehabilitation center. in addition to identifying a pressure ulcer prevention strategy, the planned research will lead to the development of testable theoretical models of the intervening process mechanisms that link the intervention to pressure ulcer reduction.

Eligibility criteria:
inclusion criteria: * spinal cord injury (paraplegia or tetraplegia) * non-ambulatory * able to undergo intervention and testing in english or spanish * at least 6 months post-injury * history of at least one serious (stage 3 or 4) pressure ulcer in the past 5 years * cognitively intact * personally expressed willingness to undertake recommended lifestyle changes for ulcer prevention. * can be reached by telephone. * reside in or within 100 miles of rancho los amigos national rehabilitation center (downey, ca) with no plans to relocate beyond this area. * agreement to participate and completion of consent form. exclusion criteria: * present serious stage 4 pressure ulcer * participation in our preliminary research studies * participating in the neuromuscular stimulation study

Keywords: pressure ulcer lifestyle redesign spinal cord injury
the effect of phosphocreatine on medical emergency team (met) treated patients

Conditions: Hypotension; Consciousness, Level Altered; Airway Disease; Respiratory Failure; Tachypnea; Bradypnea; Tachycardia; Bradycardia; Cardiac Failure; Cardiac Arrest

Summary: unexpected deaths and unplanned intensive care unit (icu) admissions are common during hospital stay and are often preceded by warning abnormalities in patients' vital signs. these abnormalities trigger medical emergency team (met) activation and up to 15% of patients visited by the met is admitted to the icu with an overall hospital stay after the met intervention of approximately 2 weeks. phosphocreatine (pcr) is a natural energy-buffering molecule associated with signals of mortality reduction in patients with acute cardiac conditions (according to meta-analytic finding from our group) and with encouraging beneficial effects on other acute organ failures (e.g. brain). the investigators designed a multi-center, randomized, placebo-controlled trial to confirm the promising beneficial effects of pcr in hospitalized patients. the investigators expects a reduction in hospital stay (measured as an increase in days alive and out of hospital at 30 days) when pcr is added to standard treatment in patients requiring met intervention.


Eligibility criteria:
inclusion criteria: 1. admitted in hospital (but outside icu) 2. age\>=18 years 3. written informed consent 4. serum creatinine \<=2 mg/dl 5. patient with impending or underlying cardiac failure or cardiac arrest, irrespectively of the primitive organ failure, and the medical emergency team (met) is called upon at least one of the following: 1. threatened airways; 2. respiratory arrest; 3. respiratory rate \ 36 breaths per min; 4. pulse rate \ 140 beats per min; 5. systolic blood pressure \< 90 mm hg; 6. sudden fall in level of consciousness; 7. fall in glasgow coma scale of \> 2 points. exclusion criteria: 1. age \< 18 years; 2. ongoing cardiac massage; 3. current hospital admission from a care nursing facility; 4. planned discharge to a care nursing facility; 5. reasons for withdrawal of life-sustaining therapy; 6. history of kidney transplantation; 7. solitary kidney (by any reason); 8. serum creatinine \> 2 mg/dl; 9. immediate need for icu admission; 10. known allergy to pcr; 11. pregnancy; 12. previous enrollment and randomization into this trial; 13. administration of pcr in the previous 30 day.
the pre-symptomatic familial amyotrophic lateral sclerosis (pre-fals) study

Conditions: Amyotrophic Lateral Sclerosis

Summary: pre-fals is a prospective natural history and biomarker study of people not yet affected with als, but who are at genetic risk for developing als. the investigators aim to recruit unaffected (healthy) people from familial als (fals) pedigrees in which a known genetic mutation associated with als has been identified; for this study, a fals pedigree is one with two biologically related individuals who have or have had als and/or ftd. individuals who may be at genetic risk for als and who belong to families with at least one affected family member who has tested positive for a known als genetic mutation may also be eligible to participate. our goal is to study the pre-symptomatic phase, onset and progression of als and to learn more about genetic and environmental factors that put people at risk for developing als.

healthy individuals from fals families with a known genetic mutation will be included in this study. we encourage people who have previously undergone genetic testing and were found to carry the mutation that affects their family as well as those who do not know their genetic status to contact us. those who wish to participate and to learn the results of genetic testing, may do so after undergoing genetic counseling. it is also possible to participate without learning the results of genetic testing. participants eligible to complete study visits will travel to miami (at our expense) approximately every 12-24 months for a period of 10 years or longer and will perform various biomarker procedures. between visits, participants will complete phone calls about their health.

Eligibility criteria:
inclusion criteria * a member of a family in which a mutation in a gene associated with als has been identified. * no symptoms to suggest the presence of als (i.e. study participants must currently be healthy). * having at least 50% probability of carrying an als associated gene mutation based on family pedigree. * willingness to undergo genetic testing, with the option of whether or not to learn the results. * willingness and availability to travel to miami for a few days approximately every 12 to 24 months to complete biomarker procedures (e.g, mri, blood draws, spinal tab/lumbar puncture, cognitive testing) exclusion criteria * diagnosis of als * any condition or situation which, in the pi's opinion, could confound the biomarker data or may interfere with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions.

Keywords: fals sod1 familial genetic testing genetic counseling als c9orf72 tardbp vcp fus pfn1
an open-label study of atomoxetine in children with attention-deficit/hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: a single arm, open-label, phase 3 multicenter study to evaluate the effectiveness and tolerability of atomoxetine (given once daily, target dose 1.2 mg/kg/day), as perceived by patients, parents and physicians, and its impact on quality of sleep in children (aged 6 through 11 years) with attention-deficit/hyperactivity disorder treated as outpatients in germany. an 8-week treatment phase is followed by a 16-week extension period.


Eligibility criteria:
inclusion criteria: * male or female outpatients who are at least 6 years of age and who will not have reached their 12th birthday * diagnosis of adhd * normal intelligence exclusion criteria: * weigh less than 20 kg or more than 60 kg at study entry * other relevant psychiatric diagnoses * are at serious suicidal risk as determined by the investigator * have a history of severe allergies * alcohol or drug abuse within the past 3 months
olopatadine hydrochloride ophthalmic solution study in chinese subjects

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate olopatadine 0.2% qd (once per day) compared to olopatadine 0.1% bid (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * chinese ethnicity; * history of allergic conjunctivitis within the last 2 years; * positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit; * clinical diagnosis of allergic conjunctivitis with specific signs and symptoms; * understand and sign an informed consent form; * willing and able to make required study visits and follow study instructions, and comply with dosing study medication as instructed; * other protocol-specified inclusion criteria may apply. exclusion criteria: * contraindications or hypersensitivity to study medications or their components; * best-corrected visual acuity (bcva) score worse than 55 etdrs letters (equivalent to approximately 0.60 logmar, 20/80 snellen, or 0.25 decimal) in either eye; * any ocular condition that could affect the study outcomes; * presumed or actual ocular infection or history of ocular herpes in either eye; * known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease; * willing and able to avoid the use of any other topical ocular medication(s) (including artificial tear products); * any significant illness that could be expected to interfere with the study, particularly any autoimmune disease; * intraocular surgery in either eye within 6 months, or ocular laser surgery in either eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma in either eye within 3 months of baseline visit; * clinically relevant recent (within 6 months of baseline visit) history of or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of a topical antihistamine/mast cell stabilizer in the opinion of the investigator; * use of systemic medication(s) on a chronic dosing regimen for less than 1 month or have changed dosage within the month prior to baseline visit; * use of any disallowed medication (topical, topical ophthalmic, systemic and/or injectable) during the period indicated prior to baseline visit. these medications are also not allowed during the study. disallowed medications include all anti-allergy therapies including those contained in prescription or over-the-counter sleeping aids; * use of cold compresses on the eyes during the course of the study; * cannot be dosed in both eyes; * cannot avoid contact lens wear during the course of the study; * therapy with another investigational agent within 30 days of baseline visit, or during the study; * women of childbearing potential who are pregnant, intend to become pregnant during the study period, breast-feeding, or not using adequate birth control methods; * other protocol-specified exclusion criteria may apply.

Keywords: allergies ocular
clinical course of interstitial lung diseases: european ipf registry and biobank

Conditions: Idiopathic Pulmonary Fibrosis; Idiopathic Interstitial Pneumonia; Interstitial Lung Diseases; Diffuse Parenchymal Lung Diseases

Summary: born out of the european union 7th framework programme funded project european ipf network (euripfnet), the european ipf registry (euripfreg) has become europe's leading database of longitudinal data from ipf patients, including control groups of patients with other lung diseases. the registry was initiated with the intention of creating a permanent and continuously growing record of well defined data on ipf in europe, in order to increase the chances of finding better treatment options for this devastating disease. clinical colleagues who would like to actively participate (both in terms of patient recruitment and data analysis) are invited to contact us (http://www.pulmonary-fibrosis.net/).

the group's work aims to foster research on idiopathic pulmonary fibrosis (ipf), the most aggressive form of an idiopathic interstitial pneumonia (iip). within the euripfreg we, the euripfreg steering committee and a growing number of external site investigators, aim to describe the natural course of ipf and other iips, to identify risk factors that are associated with the evolution of the disease and to sample biomaterials that may serve as underlying basis for translational research activities. ipf and non-specific interstitial pneumonia (nsip), as well as the other entities of iips (cryptogenic organizing pneumonia, cop; desquamative interstitial pneumonia, dip; respiratory bronchiolitis interstitial lung disease, rb-ild; lymphoid interstitial pneumonia, lip; acute interstitial pneumonia, aip) are frequently progressive, fibroproliferative diseases of unknown etiology, affecting the lung parenchyma. patients with ipf have the most devastating prognosis within the group of iips, with a median survival rate of 2-3 years.

Eligibility criteria:
inclusion criteria: * informed consent signed exclusion criteria: * no informed consent signed
compressive elastic dressing versus tr band

Conditions: Coronary Artery Disease; Myocardial Infarction; Angina, Unstable; Angina, Stable; Acute Coronary Syndrome; STEMI; NSTEMI; Ischemic Heart Disease; Atherosclerotic Cardiovascular Disease; Chest Pain; Non ST Elevation Myocardial Infarction

Summary: radial approach is widely established in cardiac diagnostic and therapeutic treatments. it has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. it also offers better comfort to patients through early mobility and lowers hospital expenses. previously, there were no specific devices for radial artery hemostasis. many different types of dressings were used in various hospitals with no standardization. this raises the question of whether specific devices surpass dressings in terms of patient comfort, time required to maintain hemostasis, and vascular complications. the primary goal of this study was to examine the effectiveness of compression dressings and hemostatic wristbands on patients undergoing cardiac procedures via radial approach in terms of patient comfort, time required to maintain hemostasis, and vascular problems. the hemostatic wristband tr bandr (terumo corporation, tokyo, japan) was utilized in one group, while compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, was used in the other.


Eligibility criteria:
inclusion criteria: * age \> 18 years * patients who agree to participate in the study and sign the consent form. * patients with an indication for coronary catheterization * clinically stable patients * patients with palpable pulses on at least one of the radial arteries. exclusion criteria: * patients who are hemodynamically unstable (systolic blood pressure less 90mmhg) * patients with radial av shunt for hemodialysis * patients with previous cabg using radial artery * patients with renaud phenomenon or lymphedema * patients who had vascular problems at the puncture site before the hemostasis process started. * failure to obtain radial access

Keywords: radial approach wristband tr band compressive dressing cardiac catheterization radial artery safeguard randomized controlled trial
phenotyping the alignment of the lower limb

Conditions: Lower Limb Deformity

Summary: in the international literature there are only few publication about the normal biomechanical parameters of the lower limb examined prospectively in healthy population. the goal of our study to determine 15 anatomical and biomechanical parameters of the lower limb using 3d reconstruction based on upright, stereo radiographs in young, healthy volunteers.


Eligibility criteria:
inclusion criteria: * age: 18-30 years * bmi: \< 30 * without orthopaedic complaint exclusion criteria: * previous surgery on lower limb or spine * developmental disorder in the patients history

Keywords: eos 2d/3d lower limb alignment lower limb rotation osteoarthritis of the knee osteoarthritis of the hip
the impact of mobile app intervention ( ickd app) on chronic kidney disease care

Conditions: Chronic Kidney Disease; Hypertension

Summary: * apply mobile app intervention ( ickd app) to current chronic kidney disease care program. * conduct a randomized clinical trial to evaluate the clinical effectiveness of this mobile device on health behavior improvement in chronic kidney disease patients.

a mhealth app (ickd app) was designed to assist ckd patients to monitor their home bio-information data. patients will be randomly assigned into the ickd app group(intervention) and traditional care group (control). participants will be randomized into an 1:1 manner (intervention : control). random assignment occurred after the consent and initial enrollment interview. individuals randomized to the ickd app will provide with the equipment after randomization. participants will follow for at least 6 months before the exit interview.

Eligibility criteria:
inclusion criteria: * subjects are 20 years old and above, chinese speaking, and able and willing to provide informed consent. * subjects own mobile devices such as cell phones and tablets. * subjects were diagnosed with chronic kidney diseases and were taking a single antihypertensive agent for more than three months or they are not receiving treatment but with systolic blood pressure ≥140 mmhg or diastolic blood pressure ≥90 mmhg. exclusion criteria: * starting dialysis or having a kidney transplant (rrt) * participating in other interventional study * cognitively impaired * unable to give consent * life expectancy less than 1 year

Keywords: mhealth mobile application chronic kidney diseases
the efficacy of nitric oxide in stroke (enos) trial

Conditions: Stroke

Summary: nitric oxide is a multimodal candidate treatment for acute stroke having a number of properties which may be beneficial in acute stroke, including lowering blood pressure, causing cerebral vasodilation, and improving central and systemic haemodynamics. nitric oxide donors are effective in experimental stroke and pilot studies in patients suggest that one, glyceryl trinitrate, can be delivered easily in a transdermal preparation. around half of all patients admitted with acute stroke are taking antihypertensive therapy immediately prior to their stroke. no data exist as to whether it is beneficial or safe to stop or continue this treatment during the acute phase. enos is a prospective, international, multicentre, randomised, parallel-group, blinded, controlled, collaborative, factorial trial designed to test two questions related to the management of blood pressure immediately post-stroke: 1. the safety and efficacy of nitric oxide, given as transdermal glyceryl trinitrate. 2. the safety and efficacy of stopping or continuing prior antihypertensive medication. previously independent adult patients who are conscious and have residual limb weakness are eligible for enrollment. central randomisation will be performed via the internet. treatment is initiated within 48 hours of stroke onset and is given as daily glyceryl trinitrate patches for 7 days. a computed tomography (ct) scan is required within 7 days of randomisation. early follow-up is performed locally over the 7 days of treatment, including blood pressure, early stroke events, and adverse events. telephone central follow-up by the trial co-ordinating centre will be performed at 3 months. the primary outcome is combined death or dependency (modified rankin score \>2).


Eligibility criteria:
inclusion criteria: * adult(\> 18 yrs). * clinical stroke syndrome with limb weakness lasting at least 1 hour i.e. not likely to be a transient ischaemic attack). * limb weakness (snss arm \<6 and/or leg \<6). * onset \< 48 hours. * conscious (glasgow coma scale \> 8). * independent prior to stroke (pre-morbid rankin scale \< 2). * meaningful consent, or assent from a relative or carer exclusion criteria: * definite need for nitrate therapy * contraindication to nitrate therapy * definite need for prior antihypertensive or anti-anginal medication * definite need for antihypertensive therapy during acute stroke * systolic blood pressure \ 220 mmhg. * patients expected to require surgical intervention * known intracerebral pathology other than stroke * other serious condition which is likely to prevent outcome assessment at 3 months * previous enrollment in enos or current involvement in another trial of an experimental drug intervention. * not available for follow-up -females of childbearing potential, pregnancy or breastfeeding. -
displacement of popliteal sciatic nerve catheters after major foot and ankle surgery

Conditions: Postoperative Pain; Regional Anesthesia

Summary: displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. a randomized controlled double blinded mri study comparing long versus short axis catheter placement. which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the best


Eligibility criteria:
inclusion criteria: * age ≥ 18 y. * major foot and ankle surgery postoperativ pain treatment with sciatic nerve catheter r * written and informed concent exclusion criteria: * patient uanble to cooperate * patients not speaking and understanding danish or english * patiens in immunosuppresive treatment * patienter with neuropathys in lower extremities * allergies to the in the protocole listes medicines * a daily opoid intake * pregnant women * patients not meeting mr-criterias (metal, claustofobia...)

Keywords: postoperative pain regional anesteshia nerve catheters sciatic nerve catheters