Kornimate/medical-research-clean huggingface dataset:
predictors of respiratory failure following extubation in the sicu

Conditions: Muscle Weakness; Renal Failure; Respiratory Comorbidities

Summary: respiratory failure following extubation causes significant morbidity and increases mortality in teh surgical intensive care unit (sicu). however the causes of respiratory failure following extubation remain poorly understood. the investigators hypothesize that extubation failure can be predicted based on preoperative risk factors as well as icu acquired morbidities including muscle weakness and renal failure.

both extubation delay and extubation failure are related to adverse outcomes. a spontaneous breathing trial is therefore recommended to predict extubation readiness. however, depending on the disease entity and local culture, a range of 10-20 per cent incidence of extubation failure has been described from tertiary care hospitals. the aim of this trial is to identify additional variables in surgical patients that can be used to support a clinician's decision on whether or not to extubate a patient's trachea. te investigators have recently developed and validated the sporc (brueckmann, 2013), a score that predicts the risk of extubation failure following surgery based on patients comorbidities and the acuity of the disease leading to surgery, and the investigators hypothesize that the sporc will also predict extubation failure in the surgical icu. in addition, it is likely that icu acquired morbidity also predicts extubation failure. in fact, the investigators have recently shown that muscle weakness is a predictor of aspiration (mirzakhani, 2013), and the investigators speculated that muscle weakness may also respiratory failure after extubation. finally, it has been suggested that the increased mortality seen in patients with acute kidney injury (aki) requiring continuous renal replacement therapy (crrt) versus end stage renal disease (esrd) patients requiring crrt can be attributed to an increased need for mechanical ventilation. (walcher, 2011). therefore, the investigators also hypothesize that acute kidney injury increases the vulnerability of patients to postextubation respiratory failure.

Eligibility criteria:
inclusion criteria: * adults (18 years of age or greater) * patients who have been extubated following mechanical ventilation in the surgical icu exclusion criteria: * preexisting end-stage renal disease * neurological disorder associated with severe muscle weakness * goals of care focused on comfort

Keywords: muscle strength respiratory failure extubation failure intensive care unit outcome prediction
comparison of outcomes of rotator cuff repair with a modified versus classic double-row suture -bridge techniques

Conditions: Rotator Cuff Tears

Summary: rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .

accompanied by shoulder pain and dysfunction

Eligibility criteria:
inclusion criteria: * full-thickness supraspinatus * degenerative tears * age range 40 :65 exclusion criteria: * subscapularis tear * small and massive tears * traumatic tears * partial -thickness tear * revisioin surgery * glenohumeral arthretic changes and shoulder instability
a study of autologous renal autologous cell therapy (react) in patients with diabetic chronic kidney disease

Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease

Summary: the purpose of the present study is to assess the safety and efficacy of up to 2 injections of react given 6 months (+4 weeks) apart (maximum).

all subjects enrolled will receive react. subjects will receive their first react injection as soon as the react product is manufactured and shipped to the clinical site. after 6 months (+4 weeks), a second injection will be given, as appropriate. each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

Eligibility criteria:
inclusion criteria: 1. the subject is male or female, 30 to 65 years of age on the date of informed consent. 2. the subject has an established diagnosis of t2dm. 3. the subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease. 4. the subject has an established diagnosis of ckd not requiring renal dialysis, defined as having an egfr between 14 and 20 ml/min/1.73m² inclusive at the screening visit and prior to react injection. 5. the subject has blood pressure less than 150/90 at the screening visit, prior to renal biopsy, and prior to react injection(s). note bp should not be significantly below the previously recorded stable pressure. 6. a minimum of 3 measurements of egfr or scr should be obtained at least 3 months apart prior to the screening visit or within the previous 24 months to define the rate of progression of ckd. the subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of ckd. the medical monitor may be consulted to ensure there is sufficient data. exclusion criteria: 1. the subject has a history of type 1 diabetes mellitus. 2. the subject has a history of renal transplantation. 3. the subject has a serum hba1c level greater than 10% at the screening visit. 4. the subject has uncontrolled diabetes (defined as metabolically unstable by the investigator). 5. the subject has hemoglobin levels less than 9 g/dl prior to each react injection.
cardiovascular longitudinal evaluation & assessment of risk (clear) study

Conditions: Cardiovascular Disease

Summary: the burden of cardiovascular disease (cvd) is considerable, despite many advances in diagnosis, clinical management and drug therapy. the world health organization estimates 30% of global deaths are attributable to cvd and whilst mortality rates in developed countries are falling, it remains the largest single cause of death (who, 2007). nineteen out of every 100 deaths in australia are attributed to cvd, with an annual cost of $1.47 billion (aihw, 2006). assessing the risk of future cardiovascular events is traditionally based on a number of 'risk-factors' determined by observational clinical studies such as the framingham cohort. recent evidence however invalidates their use in both the highest and lowest risk groups and raises questions about applying such methods in changing risk-behaviour. a considerable number of new risk markers have surfaced in recent years (including various biomarkers, pulse wave velocity and measures of arterial function). unfortunately their long-term predictive capacity is largely unknown, particularly when compared with existing risk factors. the aims of this study are to provide objective longitudinal data for a wide variety of risk markers both in current use and in development. participants of current on-going clinical studies at will be approached to lengthen their observation period for the purposes of determining long-term clinical outcomes. standard clinical observations and data obtained within the participant's enrolled studies will be collated into an electronic database. all existing and future studies must have individual approval from an appropriate ethics committee with signed consent. the baseline studies and follow-up assessments of this cohort will be correlated with cardiovascular events, hospitalizations and mortality. in addition, volunteers can be directed to appropriate clinical studies in cvd, thereby enhancing recruitment, encouraging good quality clinical studies and advancing knowledge of cardiovascular disease prevention.

design: longitudinal cohort study objectives: * establish a database of cardiovascular risk factors * correlate with long-term cardiovascular outcomes * assign suitable volunteers to appropriate clinical studies

Eligibility criteria:
inclusion criteria: * patients above 18 years of age exclusion criteria: * risk assessment would constitute harm to patient * informed consent not obtainable

Keywords: cardiovascular risk longitudinal prospective
alveolar cleft repair using osteoinductive ceramics

Conditions: Cleft Palate Children; Cleft Alveolar Ridge; Cleft Lip and Palate

Summary: in this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.

rationale: patients who undergo alveolar cleft grafting have to deal with postoperative pain and comorbidity due to harvesting of autologous bone. objective: to evaluate if using calcium phosphate based scaffolds for alveolar cleft grafting is as effective as the use of an autologous bone graft. study design: a 'stepped wedge' randomized controlled trial will be conducted by four centres. study population: children between the ages of 8 to 12 years with a unilateral alveolar cleft. intervention: study group undergoes alveolar cleft grafting with the use of a calcium phosphate based scaffold, the control group undergoes the same procedure, but with the use of an autologous chin bone graft. main study parameters/endpoints: main study outcome is one year postoperative residual bone volume in the reconstructed alveolar cleft. secondary objectives of importance are postoperative pain and eruption of the tooth adjacent to the cleft through the reconstructed area. nature and extent of the burden and risks associated with participation, benefit and group relatedness: patients in the control group will undergo a procedure that is currently seen as the gold standard. patients in the study group will undergo the exact same risks as the control group, except there is no risk for donor site morbidity and postoperative pain is significantly less. postoperative clinical and radiological evaluation of both groups is according to current treatment standards.

Eligibility criteria:
inclusion criteria: * unilateral alveolar cleft, early secondary alveolar cleft closure exclusion criteria: * cleft lip and palate in a syndromic context

Keywords: cleft palate cleft lip alveolar cleft calcium phosphate ceramics bone graft
empagliflozin in heart failure dialysis patients

Conditions: Heart Failure; Hemodialysis

Summary: empagliflozin is not still approved for glomerular filtration rate \< 20 cc/min/1.73m2. considering the cardiac and renal benefits of this drug, the evaluation of the safety and efficacy of empagliflozin for heart failure dialysis patients seems to be mandatory.

heart failure dialysis patients with residual renal function will be followed up on empagliflozin based on echocardiographic parameters, pro-brain natriuretic peptide levels, diuresis volume, and serum acidity.

Eligibility criteria:
inclusion criteria: * heart failure on dialysis with residual renal function exclusion criteria: * dialysis patients with no residual urine
covid-19 messaging to underserved communities - 2nd experiment

Conditions: Covid19

Summary: the aim of the study is to build off results from our first experiment (nct04371419) , and test whether messages that acknowledge racial injustice on behalf of institutions affect the retention of knowledge and movement of beliefs and behavior with respect to covid-19. the investigators will also test the effect of concordance of providers and whether highlighting the unequal burden of the disease has additional effects on knowledge, beliefs and behavior regarding covid-19. the sample will include african american and white adult americans and oversample those with less than a college degree.

recent data have shown that covid19 is disproportionately infecting and killing african americans and latinx people in the united states. moreover, since our last experiment, the killing of george floyd by minnesota police has raised awareness of structural racism in the united states. the aim of the study is to build off results from our first experiment (nct04371419) , and test whether messages that acknowledge racial injustice on behalf of institutions affect the retention of knowledge and movement of beliefs and behavior with respect to covid-19. the investigators will also test the effect of concordance of providers and whether highlighting the unequal burden of the disease has additional effects on knowledge, beliefs and behavior regarding covid-19.the sample will include african american and white adult americans and oversample those with less than a college degree.

Eligibility criteria:
inclusion criteria: * adults who self-identify as african american or white. * an oversample of individuals with less than a college education exclusion criteria:
is multifactorial nutritional treatment for undernutrition in older adults in primary care cost-effective?

Conditions: Frail Older Adults

Summary: the hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.


Eligibility criteria:
inclusion criteria: * screening for nutritional risk exclusion criteria: * terminal condition or do not wish to participate
electronic chromoendoscopy for polyp characterization

Conditions: Colorectal Polyp

Summary: to assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.


Eligibility criteria:
inclusion criteria: * patients undergoing screening or surveillance colonoscopy * written informed consent exclusion criteria: * inadequate bowel preparation * polyposis syndromes * history of colectomy * use of anticoagulants
tdcs effects on brain plasticity in aphasia treatment

Conditions: Aphasia; Stroke

Summary: the efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. the prospective study will monitor the effects of combined language therapy and tdcs through structural and functional mri.

the efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. the prospective study will monitor the effects of combined language therapy and tdcs through structural and functional mri. this randomized, placebo-controlled, double-blinded pilot study will recruit ten chronic stroke patients with broca's aphasia randomly assigned either to sham or an anodal tdcs groups. following speech and language assessment, all the participants will receive 20 minutes of individualized language therapy daily for ten days in two consecutive weeks. simultaneously, the treatment group will receive 20 minutes of 2ma anodal hd-tdcs over the left ifg, while the sham group will receive the 30s of 2ma anodal hd-tdcs. structural, resting state and task activated functional mri will be performed. data acquisition will be performed before, immediately after and two months after the treatment. repeated measure anova for changes in picture-naming accuracy and response time will be performed as a within-subject factor between sham and anodal tdcs. pearson's correlation coefficient of left ifg and its homolog in the right hemisphere through independent component analysis (ica) of low-frequency fluctuations in resting-state and task activated state will be compared for functional connectivity analysis for ifg and other major languages hubs for oral language production between groups.

Eligibility criteria:
inclusion criteria: 1. history of a single unilateral left-hemispheric stroke, 2. right handedness 3. demonstrated features of broca's aphasia 4. cantonese speaker 5. comprehension sufficient to carry out tasks 6. no history of other neurological diseases exclusion criteria: 1. aphasia due to reasons other than stroke, traumatic brain injury 2. bilateral or multiple brain lesions 3. wernicke's aphasia and other speech disorders, degenerative, psychiatric or metabolic disorders 4. deaf, blind, pregnant/ or preparing for pregnancy, cognitive issues, tattoos 5. have cochlear implants, pacemaker, surgical nails for bone fracture, artificial joints, dental braces, dentures 6. taking anti-depressant medications

Keywords: tdcs mri aphasia stroke speech therapy
tele-diagnostics for remote parkinson's monitoring

Conditions: Parkinson's Disease

Summary: the purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring parkinson's disease (pd) motor symptoms. the current standard in evaluating symptoms is the unified parkinson's disease rating scale (updrs), a subjective, qualitative ranking system. the main goal of this research is to develop a quantitative system, kinesia homeview, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease exclusion criteria: * inability to follow the required clinical instruction * subjects with cognitive impairments that would prohibit them from properly using the kinesia homeview system * subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable * subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.
pulsed electromagentic field in haemophilia

Conditions: Hemophilia A

Summary: to assess the effect of pulsed electero- magnetic field on swelling, range of motion and muscle strength of hemarthrotic knee joints of haemophilic subjects.

haemophilia is an x-linked hereditary sex recessive disorder that impairs the body's ability to make blood clots. it includes two types: a (fviii deficit factor) and b (ix deficit factor), depending on fviii/fix percentage in blood. the severity of haemophilia is classified into (severe: \ 5%). the prevalence of haemophilia a is 1: 5000 live births and haemophilia b is 1: 30000 live births. this disease is characterized by hemarthrosis which is a hemorrhage in the locomotor system, mainly muscles and joints. joint bleeding mainly occurs in knees, ankles and elbows. haemorrhage in the muscle or joints accounts for 80% to 90% of all bleeding episodes in people with haemophilia. the most commonly affected joints in non-prophylaxis patients are the knees (45%) which is thought to be due to the large size of the synovial membrane and large rotational forces present. it is followed by the elbows (30%), ankles (15%), shoulders (3%), and wrists (2%). bleeds are best detected by the patients themselves as bruising and swelling or described as a feeling of warmth or tingling within the joint preceding the clinical signs. pulsed electromagnetic field (pemf) has been reported to be effective in reducing pain, healing of ulcers and promote bone healing, and treating osteoarthritis and inflammatory diseases of the musculoskeletal system. also, it was reported that pemf exposure significantly increases the anti-inflammatory effect, suggesting its potential therapeutic use in the treatment of inflammatory bone and joint disorders.

Eligibility criteria:
inclusion criteria: * type a hemophilia (moderate) * free from any musculoskeletal deformities. exclusion criteria: * patients who performed surgical procedures 6 weeks before conducting the study
impact of diabetes and glucose control during rehabilitation after stroke

Conditions: Cerebrovascular Accident; Diabetes; Hyperglycemia

Summary: to assess whether patients with diabetes have less clinical improvement during inpatient rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation is an adverse prognostic indicator.

patients with diabetes have a higher mortality rate and more severe disability from stroke compared to those without diabetes. those with hyperglycaemia tend to progress to a larger final stroke size. diabetes and hyperglycaemia may affect the ability of the patient to clinically improve, independent of the degree of initial impairment. we will perform a retrospective review of medical records of stroke patients admitted to an inpatient rehabilitation unit. we will compare outcomes of changes in disability scales (fim and barthel) from admission to discharge, length of stay and hospital events between those with and without diabetes. amongst those with diabetes, we will also assess whether those with higher mean blood glucose levels during their inpatient rehabilitation stay have worse outcomes.

Eligibility criteria:
inclusion criteria: * inpatient rehabilitation for acute stroke exclusion criteria: * medical records unavailable
comparison of the action of drugs in the body and safety of n8 and advate® in haemophilia a subjects

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted in europe and asia. the aim of this clinical trial is to compare two recombinant factor viii drugs, turoctocog alfa (recombinant factor viii (n8)) with advate®, in haemophilia a subjects, investigating the action and safety of the drugs.


Eligibility criteria:
inclusion criteria: * severe haemophilia a (fviii level less than or equal to 1%) * treatment history of more than 150 exposure days with recombinant or plasma-derived fviii replacement products * hiv or hcv negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial exclusion criteria: * presence of any bleeding disorder in addition to haemophilia a * inhibitor titre greater than or equal to 0.6 bethesda units (bu) at screening and past history of inhibitor * abnormal renal function tests * known hypersensitivity to advate®