Kornimate/medical-research-clean huggingface dataset:
benchmarking the ios balance application against the berg balance test

Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Ankle Injuries; Knee Injuries; Accidental Falls; Spinal Injuries

Summary: this study aims to benchmark the performance of an ios application against the berg balance scale (bbs), which is the most commonly used assessment tool by clinicians for measuring balance across the continuum from acute care to community-based care. an iphone will be tied around the waist of the participant and concurrent measurements will be taken for five of the fourteen stances which comprise the bbs.

'project balance' aims to make balance an actionable component of an individuals health, allowing a long term intervention via a monitoring and training of balance health much before a fall happens. towards this end, we have designed an ios application and a belt. the phone is kept stable against the lower back of the participant using the belt. the application turns on the accelerometer in the phone to sample acceleration along x (media lateral) and z (anterior posterior) axis. these displacements from the mean are used to calculate the root mean square of a person which acts a proxy score for postural sway. (postural sway is defined as the phenomenon of constant displacement and correction of the position of the center of gravity within the base of support) studies in the past have compared the use of accelerometers to the use of the clinical measured of timed up (tug) test and berg balance scale (bbs) in the assessment of postural stability and indicated that there is a high correlation between bbs, tug and accelerometry. accelerometry has also found to be able to distinguish between sway responses to differing balancing conditions and between fallers and non-fallers. we aim to conduct a benchmarking study for our ios application against the bbs.

Eligibility criteria:
inclusion criteria: between the ages of 18 - 69 selected to undergo a berg balance sale impairments including : ankle injures, knee replacements, hip replacements, knee injuries, ligament tears etc. exclusion criteria: subjects will be excluded from participation if they have peripheral neuropathy (clinically diagnosed or if they had symptoms of numbness/tingling in the lower extremities); pain of any level presenting simultaneously in both lower extremities; or unilateral lower extremity pain \>3 on the 11 point visual analog (box) scale. pregnant women will be excluded.
bedside silo versus operative closure for gastroschisis

Conditions: Gastroschisis

Summary: the hypothesis is that there is no difference between bedside silo placement and operative closure in return of bowel function, ventilator dependence, or length of stay. the primary outcome variable between the two techniques will be determined from this study that can then be used to develop a definitive study. the likely variables will be length of time to meet discharge criteria, length of hospitalization, time to full feedings, time on mechanical ventilation and total hospital charges.

a strategy of blocked randomization will be utilized. the randomization will be blocked in groups of 4. randomization sequence will be kept by the principal investigator. after permission is obtained, the next assignment will be obtained. this method assures that the physician obtaining permission will be blind to the treatment group. the treatment groups will consist of the same medical management, feeding regimen and discharge criteria. the interventions will be either bedside silo or operative attempt at closure. during attempt at primary closure, the abdomen will be closed completely if the staff anesthesiologist and surgeon agree the belly is not too tight based on ventilatory parameters, vital signs and appearance. if either the surgeon or anesthesiologist should feel the closed abdomen is too tight, a ringed silo will be placed in the operating room, the same silo used in the bedside treatment arm, and the child will continue in the study. when a silo is placed either in the operating room due to inability to close the abdomen or at the bedside, they will be managed the same way. the skin will be dressed in the standard fashion (betadine jelly, xeroform and kerlix). the dressing allows visualization of the bowel. no reductions will be done the day of placement. after one night of observation a tie will be gently placed to apply downward pressure on the bowel. this pressure will not be allowed to increase the peak ventilator pressure by more than 2 cm h2o. one tie will be placed each subsequent day until the tie is within 2 cm of the skin at which point the patient will be scheduled for operative closure the day following the placement of the tie. the medical management is controlled for resuscitation, sedation, ventilation and feeding between groups.

Eligibility criteria:
inclusion criteria: * patients with gastroschisis exclusion criteria: * born prior to 34 weeks estimated gestational age * another congenital anomaly influencing the respiratory status, gastrointestinal status, or the length of hospitalization and recovery.

Keywords: gastroschisis silo operative closure
use of the atkins diet for children with intractable epilepsy: a comparison of daily carbohydrate limits

Conditions: Epilepsy

Summary: this study is designed to further investigate the use of a modified atkins diet for children with intractable, daily seizures. it is a follow-up to a study recently completed by our institution. in this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.


Eligibility criteria:
inclusion criteria: * ages 3-18 * daily seizures or 7 per week * failed at least 2 anticonvulsants exclusion criteria: * prior use of the atkins diet for over 1 week * significant heart, liver, or kidney disease

Keywords: epilepsy ketosis atkins seizures
risk factors for acquired cardiovascular disease in adults with congenital heart disease

Conditions: Congenital Heart Disease

Summary: this research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. this knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

advances in surgical and clinical management of patients with congenital heart disease has made survival to adulthood an expectation. today there are more than 1 million adult survivors of congenital heart disease, but increasing age brings additional concerns for this patient population. although the literature remains scarce, existing evidence suggests that inactivity, obesity, diabetes, cancer, and acquired cardiovascular disease may be at least as prevalent in patients with congenital heart disease, if not more so, than in an age-matched general population. acquired cardiovascular disease is likely to impact substantially on long-term survival and quality of life in these patients with palliated and already fragile hearts. this research study is to determine the risk factors for acquired heart disease, in adults with congenital heart disease. this knowledge is important to develop and target ways to prevent or delay the onset of acquired heart disease in adults with congenital heart disease.

Eligibility criteria:
inclusion criteria: * male or female over 18 years of age * moderate or complex congenital heart disease * willingness to consent exclusion criteria: * pregnancy * surgery within 6 months * unrepaired cyanotic heart disease * patients with eisenmenger syndrome physiology

Keywords: congenital heart disease acquired cardiovascular disease
pharmacokinetic, safety and efficacy study of oms201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones

Conditions: Urinary Calculi; Urinary Stones; Urinary Tract Stones; Renal Calculi; Kidney Stones

Summary: the objectives of the study are to assess the systemic exposure, safety and efficacy of three concentrations of oms201 in subjects undergoing retrograde ureteroscopic removal of upper urinary tract stones.

the main objective is to estimate the systemic exposure of oms201 in retrograde ureteroscopic treatment of upper urinary tract stones. safety will be assessed by vital signs, laboratory values and adverse events. exploratory efficacy measures will assess the effect of oms201 on postoperative pain, duration of surgery and ease of placement of a ureteral access sheath.

Eligibility criteria:
inclusion criteria: * 18 - 65 years of age. * subject is undergoing retrograde ureteroscopic removal of renal-collecting system or ureteral stones for which general anesthesia will be used. exclusion criteria: * no allergies to any of the individual ingredients in oms201. * subject taking a prohibited medication. * pregnant woman, nursing mother, or woman of child-bearing age unwilling to take contraception for the duration of the study. * subject who has had a renal transplant, has a single kidney, has compromised renal function, or has evidence of papillary necrosis. * subject who has evidence of a clinically significant urinary tract infection. * subject who has a prior history of open or laparoscopic urinary tract surgery, or a history of a ureteral stricture. * subject who has congenital anomalies that would engender an increased procedural safety risk. * subject with a history of clinically significant chronic or episodic hypotension. * subject's physical examination is significantly abnormal for purposes of the study as determined by the investigator. * subject's screening laboratory evaluations are not within normal limits and abnormal results are determined by the investigator to be clinically significant. * subject is at risk from anesthesia. * subject is on chronic diuretic use. * subject has a present condition or history of any clinically significant medical disorder and is determined by the investigator to be an unsuitable candidate for receipt of an investigational drug.

Keywords: urinary calculi urinary stones urinary tract stones renal calculi kidney stones calculi urolithotomy ureteroscopy
silver alloyed urinary catheters and incidence of catheter acquired urinary tract infections (uti)

Conditions: Urinary Tract Infection

Summary: this study is a single blinded (outcome assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).


Eligibility criteria:
inclusion criteria: * adults in elective surgery requiring urinary catheterization exclusion criteria: * patients who has or recently (within 3 weeks) had a urinary catheter * signs of urinary tracts infection * previous radiation therapy in lower pelvis * latex allergy * cognitive impaired * do not understand swedish language.

Keywords: catheterization urinary tract infection elective surgery
immune and endocrine function in post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorders

Summary: this is a study investigating immune function and relationships to the hypothalamic-pituitary-adrenal (hpa) axis in post-traumatic stress disorder (ptsd) compared to controls without ptsd. the study involves 99 adult veterans and civilian subjects over a 3 year period. the study involves measuring immune and neuroendocrine parameters from blood samples obtained before and after a dexamethasone suppression test. the aim of the study is to determine whether immune alterations exist in ptsd and whether the immune-hpa axis interactions in this disorder are different from non-ptsd subjects with the future aim of studying whether immune dysregulation in ptsd may be linked to the increased risk for medical and psychiatric comorbidity in this population.

the subjects undergo a thorough medical (physical and blood/urine tests) and psychiatric evaluation to determine eligibility after signed informed consent is obtained. if eligible, the subject will complete questionnaires and undergo structured clinical interviews with a study psychiatrist. the subject will then undergo a 2-day testing period during which time, blood is drawn each morning at 8 am, with the subject taking 0.5 mg of dexamethasone (a synthetic steroid) at 11 pm prior to the second day of blood testing. about 80 ml of blood will be drawn on each morning. the blood collected will then be assayed for cortisol dexamethasone, lymphocyte glucocorticoid receptor levels; cytokine levels in plasma and lipopolysaccharide stimulated and unstimulated whole blood (il-2, sil-2r, il-6, sil-6r, and il-10); lymphocyte subsets (t helper and suppressor, b, and natural killer cell numbers), and antigen stimulation responses to tetanus and candida. in addition, blood from the first day of testing will undergo ex vivo challenge with dexamethasone at varying concentrations to determine differential cytokine sensitivities to steroid exposure in subjects.

Eligibility criteria:
* subjects with dsm-iv criteria of ptsd and control subjects without any axis i diagnosis, both groups of subjects are not on any psychotropic medications or medications that could interfere with the biological results, and do not have unstabilized medical conditions or neuroendocrine or immune disorders; * do not have comorbid psychosis, bipolar disorder, or substance use disorders; * have the capacity to give written informed consent; * do not have abnormalities on medical evaluation/physical examination; * are not a danger to self or others; * women subjects are not pregnant or lactacting, and use a safe form of contraception with a negative pregnancy test.
prevena™ vs dermabond in groin wound infections in vascular surgery

Conditions: Wound Infection

Summary: this study evaluates the clinical efficacy and cost effectiveness of prevena incision management system versus dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. half of the patients will receive dermabond and the other half will receive the prevena incision management system for their groin wounds.

dermabond and the prevena incision management system are both fda approved wound care products. prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. dermabond is a surgical glue which holds the wound together to prevents infection. prevena is more expensive to apply. however, the hypothesis is that the prevena system will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.

Eligibility criteria:
inclusion criteria: 1. in need of elective vascular procedure requiring ≥8 cm groin incision. 2. able to provide consent 3. able to care for wound or have support person to complete wound care 4. willing to comply with follow-up exclusion criteria: none
biomarker directed treatment in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this pilot study is being mounted to assess whether treatment assignment by ercc-1 gene expression status suggests better clinical results from historical experience in metastatic colorectal cancer (mcrc). in wild type kras mcrc patients treated with either folfox or folfiri in combination with cetuximab the median response rate is approximately 60-65%. biomarker directed treatment in this study may demonstrate that patients with low ercc-1 treated with folfox and cetuximab, and those with high ercc-1 treated with folfiri and cetuximab, will improve response rate to 70-75%. kras wild type patients will be treated with 6 cycles of one of the following regimens chosen for optimization based on patient characteristics (primary treatment phase). patients with ercc-1 \ 1.7 relative gene expression of ercc-1 over over ß-actin (ercc-1 high) will be assigned to treatment with folfiri in combination with cetuximab.


Eligibility criteria:
inclusion criteria: 1.1 inclusion criteria for pre-screening phase: * untreated advanced metastatic colorectal cancer patients * adequate tissue to evaluate for genotyping (10 x 10µm thick formalin fixed paraffin embedded tissue sections and one corresponding he stained slide or a ffpe tumor block) 1.2 inclusion criteria for treatment phase: patients must fulfill all criteria listed below prior to enrolment in the study: * untreated wild-type kras metastatic colorectal cancer * previous adjuvant therapy must have been completed \> 6 months before therapy initiation on this study * age \>18 years * measureable disease with ct or mri * ecog performance status of 0-2 * adequate organ function * hematologic: * absolute neutrophil count \> 1,500/µl * hemoglobin \>9 mg/dl * platelet count \>100,000 /µl * renal: * serum creatinine \ 30 ml/min * hepatic: * serum bilirubin \< 1.5 mg/dl exclusion criteria: * creatinine clearance below 30 ml/min * patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis dcis of the breast treated with lumpectomy alone with curative intent. * patients with a history of severe cardiac disease; e.g. nyha functional class iii or iv heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina. * other known co-morbidity with the potential to dominate survival * hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs * pregnant or breast feeding women * any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Keywords: metastatic colorectal cancer mcrc ercc-1 ercc1 agmt
the relationship between cleft lip and / or palate (different types) and abo blood groups.

Conditions: Cleft Lip and Palate

Summary: direct benefit of the research to assess the relationship between cleft lip and / or palate (different types) and abo blood groups.

376 egyptian cleft lip and/or palate patients ( age ranged from 2 days to 15 years ) with no syndrome. blood group from records will be collected an d then assess the relationship between cleft lip and / or palate (different types) and abo blood groups.

Eligibility criteria:
inclusion criteria: * egyptian patients with cleft or/and palate * the children's age ranged between 2 days and 15 years. exclusion criteria: * syndromic patients
the care of stroke in ziekenhuis oost-limburg

Conditions: Stroke

Summary: a stroke occurs when the blood circulation is hampered due an ischemic or hemorrhagic event. previous, a stroke was treated only with anti-aggregation. over time, multiple studies have showed a positive effect of intravenous thrombolysis with rt-pa (recombinant tissue plasminogen activator) in comparison with the standard treatment (anti-aggregation). since 2015, thrombectomy was proven to have an added value in combination with thrombolysis. thrombectomy is an endovascular technique where the thrombus is removed or fragmented. diagnosis and treatment of stroke will have a significant impact on the health-economic status of the patient. however, little data is known. unfortunately, the outcome after diagnosis with a stroke is not well documented. therefore, this follow-up study over a time period of one year, will give us a sufficient amount of data to evaluate patients diagnosed with a stroke in the hospital of genk.


Eligibility criteria:
inclusion criteria: * signed informed consent * older than 18 years * diagnosed with stroke exclusion criteria: * younger than 18 years

Keywords: thrombectomy thrombolysis health-economic status outcome after stroke
vehicle registry: venous stenting for iih in the mena region

Conditions: Idiopathic Intracranial Hypertension (IIH)

Summary: the vehicle registry is a multicenter observational study aimed at evaluating the management and outcomes of patients with idiopathic intracranial hypertension (iih) undergoing venous sinus stenting in the middle east and north africa (mena) region. the study focuses on assessing clinical characteristics, treatment efficacy, safety, and the role of venous sinus stenting as a therapeutic modality in iih.

idiopathic intracranial hypertension (iih) is a condition characterized by elevated intracranial pressure without an identifiable cause, leading to symptoms such as headaches, visual disturbances, and potential vision loss due to papilledema. the condition predominantly affects obese women of childbearing age and is associated with risk factors like obesity, recent weight gain, hypothyroidism, and polycystic ovary syndrome (pcos). venous sinus stenosis has been implicated in the pathophysiology of iih. venous sinus stenting has emerged as a promising treatment option for patients who are refractory to medical therapy or intolerant to medications like acetazolamide. the vehicle registry collects real-world data from multiple centers in the mena region to evaluate the efficacy and safety of venous sinus stenting in patients with iih. the registry analyzes patient demographics, clinical presentations, imaging findings, treatment details, and outcomes over a six-month follow-up period to improve understanding and management of iih in this population.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 60 years. diagnosed with idiopathic intracranial hypertension (iih) based on the modified dandy criteria, including: symptoms of increased intracranial pressure (e.g., headache, visual disturbances). elevated opening pressure (\>250 mm h₂o) on lumbar puncture with normal cerebrospinal fluid composition. no evidence of intracranial pathology (e.g., mass lesion, hydrocephalus) on neuroimaging. presence of papilledema. evidence of venous sinus stenosis on magnetic resonance venography (mrv) or digital subtraction angiography (dsa). refractory to medical therapy or intolerant to medications (e.g., acetazolamide). willingness to undergo venous sinus stenting. provided informed consent for participation. exclusion criteria: * secondary causes of intracranial hypertension (e.g., cerebral venous sinus thrombosis, neoplasm). coagulopathies or contraindications to antiplatelet or anticoagulation therapy. pregnancy or lactation. incomplete baseline data or inability to complete follow-up assessments. severe comorbid conditions that preclude endovascular procedures.

Keywords: venous sinus stenosis venous sinus stenting papilledema middle east and north africa (mena) magnetic resonance venography (mrv)
the lullaby project as a musical intervention for pregnant individuals with epilepsy

Conditions: Epilepsy; Pregnancy Related

Summary: this study's proposed intervention is the randomized participation of pregnant individuals with epilepsy in the lullaby project coordinated by a musical institution in toronto. the purpose of this present study is to investigate the potential benefits of the lullaby project on pregnant individuals with epilepsy. namely, effects on quality of life-related to epilepsy, symptoms of depression and anxiety, perceived stress, and feelings of empowerment.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * currently pregnant and primiparous * able to provide informed consent * able to have internet access * have a confirmed diagnosis of epilepsy based on eeg or clinical evidence exclusion criteria: * need of a language interpreter to provide informed consent and/or communicate with the mh-rth musician * prior involvement in the lullaby project

Keywords: music empowerment