Kornimate/medical-research-clean huggingface dataset:
the role of synovectomy in pain reduction following total knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: osteoarthritis (oa) is the most common joint disease, causing severe pain due to joint inflammation (synovitis). while total knee arthroplasty (tka) is commonly performed to reduce pain, 20% of patients are dissatisfied with their outcome post-surgery. this dissatisfaction is caused by persistent pain post-tka due to synovitis that is not routinely removed during surgery. to address this problem, a synovectomy can be performed during tka, which involves resecting the inflamed layer of tissue lining the joint, called the synovium, and its associated sensory nerve endings. since the synovium will regenerate in the months post-surgery, synovectomy only transiently reduces pain after tka. the proposed study will help ascertain the benefits and effects of synovectomy in patients who are more likely to experience poor satisfaction (driven mostly by pain) post-tka. this study will include 62 patients undergoing tka due to end-stage oa who have moderate to severe synovitis, as determined by ultrasound assessment. patients will be randomized (1:1) to undergo a tka with synovectomy or without synovectomy. primary and secondary outcomes will be assessed through patient-reported levels of pain and function, results from physical performance tests, and quality of life (qol) scores. these measures will be recorded pre- and post-surgery for comparison. through demonstrating that synovectomy can at least transiently reduce pain post-tka, this study will provide evidence for the development of medical therapies that target the synovium to slow its regrowth. this will be transformative for the long-term management of joint pain and synovitis post-surgery, thus significantly improving patients' overall qol.


Eligibility criteria:
inclusion criteria: 1. males or females over the age of 40 diagnosed with knee osteoarthritis 2. scheduled for first unilateral total knee arthroplasty 3. moderate to severe (at least grade two) synovitis and synovial hyperplasia, as determined by ultrasound assessment 4. referred to the pre-admission clinic at university hospital exclusion criteria: 1. bilateral, uni-compartmental, or revision total knee arthroplasty 2. osteoarthritis due to genetic syndromes (e.g., ehlers-danlos syndrome, etc.) 3. known inflammatory arthropathy, another rheumatic disease, or disease-modifying anti-rheumatic drug (dmard) use (e.g. methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, tnf inhibitors, etc.) - note: gout is not an exclusion 4. joint injection (steroid or viscosupplement) within 12 weeks of pre-admission clinic appointment date 5. cannot read, write, or understand english (printed instructions are provided in english only) 6. any factors precluding patients from attending follow-up appointments (e.g., socio-economic limitations, distance from clinic, no access to home/cell phone, etc.). 7. cognitive impairment or psychological problems that preclude the ability to understand instructions 8. not able to follow up at routine standard of care post-operative visits
a comparison of coated and uncoated stents in renal artery treatment.

Conditions: Renal Artery Stenosis

Summary: the primary objective of this study is to compare the safety and performance of the palmaz genesis™ balloon expandable stent, with or without sirolimus coating in the treatment of renal artery stenosis, measured at 6 months follow up via angiography.

multi-center, prospective, controlled, non-randomized investigational feasibility study. one hundred (100) patients with de novo or restenotic renal artery lesions consisting of \>= 50% stenosis and reference vessel of \>= 4.0 to \<= 8.0 mm in diameter will be sequentially included, 50 without sirolimus coating, followed by 50 with sirolimus coating palmaz genesistm. patients will be followed for 24 months post-procedure, with all patients having clinical assessments at discharge, 1,6, 12 and 24 months. this study will be conducted at twelve investigational sites. it is anticipated that the total length of time required to complete the study will be 46 months.

Eligibility criteria:
inclusion criteria: 1. clinical indication for renal artery revascularization of atherosclerotic renal artery stenosis \>=50% as measured by operator or estimated original vessel diameter, based on healthy vessel segment and contralateral side. 2. the reference vessel renal artery must be \>= 4mm and \<= 8 mm by visual estimate. 3. the patient must have a baseline serum creatinine of \<= 5.0 mg/dl. exclusion criteria: 1. total occlusion of the renal artery. 2. lesions which would require more than 2 stents. 3. lesions which are in arteries to transplanted or bypassed kidneys. 4. abdominal aortic aneurysm \> 4.0 cm in diameter. 5. patients with asa classification \>=4.
management of pediatric distal radius fractures : conservative treatment versus surgical reduction

Conditions: Fracture, Radius

Summary: to compare functional and radiological assessment between two groups of children with displaced distal radius fractures : those who will receive surgical reduction and those who will not.

distal radius fractures are the most frequent fractures seen in pediatric population accounting for about 20-30% of all fractures in children , for the non-displaced pediatric distal radius fractures , it is agreed widely to be just managed by an immobilization cast in the emergency department . however when it comes to the displaced fractures , different centers have different options of management , mostly including either the surgical anatomical reduction under general anesthesia then casting with or without using other fixation method which is mostly k-wires , or the other option includes only casting in the emergency department without trial of reduction or just a trial of realignment under sedating agent , this second option depends on the unique phenomenon of remodeling in the pediatric fractures , as unlike adults, in growing children, remodeling can restore the alignment of the displaced fractures to a certain extent, making anatomical reduction less essential , specially when it comes to distal radius as the distal radial and ulnar physes are responsible for about 80% of forearm length and for 40% of upper limb length that making their remodeling potential can approach upto 100% . depending on that the question was that if the fracture will be fully remodeled with no functional or range of motion disturbance on the conservative option so what the essentiality of the surgical option can be . along with exposing the child to the dangers of general anesthesia , the minor complications that can occur with k wires (as neuropraxia , pin tract infection or migration of the k wire) , emotional and financial load . in a cost analysis for different options of treatment in displaced pediatric distal radius fractures , the cost of surgical option exceeds the conservative one by multiple times . according to that a lot of the current literature have suggested to consider conservative treatment of pediatric displaced distal radius fractures to be the gold standard and fundamental option of treatment . in this study the investigators question the effectiveness of conservative treatment to displaced pediatric distal radius fractures (casting in the emergency department) in comparison to the surgical anatomical reduction in matters of functional and radiological parameters .

Eligibility criteria:
inclusion criteria: * all children aged 3 to 10 years * both genders * patients presenting with displaced distal radius fractures exclusion criteria: * intra articular fractures * greenstick and buckle fractures * fractures with more than 1 week duration * non displaced fractures * salter harris fractures * open fractures * fractures with neurovascular bundle injury * poly trauma patients * patients with pathological bone diseases as osteogenesis imperfecta or cp (cerebral palsy) . * galeazzi fractures
determinants of disease severity in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: objectives: i. determine specific clinical features, molecular abnormalities, and laboratory-based biological markers of free radical stress that are associated with amyotrophic lateral sclerosis and influence disease severity.

protocol outline: this is a screening and diagnostic study. blood and urine samples are collected from patients every 2 months for 1 year. all samples are evaluated for measures of free radical damage and levels of the body's own antioxidant activity.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- clinically diagnosed probable or definite, sporadic or familial amyotrophic lateral sclerosis --patient characteristics-- pulmonary: no artificial ventilation required other: no other neurodegenerative diseases no concurrent or history of unstable medical illness

Keywords: amyotrophic lateral sclerosis motor neuron disease neurologic and psychiatric disorders rare disease
detection of arousal with facial micro-expression in severe brain-damaged patient

Conditions: Consciousness Disorder

Summary: severe brain injuries lead to disorders of consciousness after coma. during this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. emotional facial expressions are a significant part of this clinical assessment. they are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. these micro expressions are usually produced when one tried to voluntary hide emotional expressions. in this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. this ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.


Eligibility criteria:
inclusion criteria: * brain-damaged patient (stroke, traumatic brain injury, anoxia) * disorder of consciousness (crs-r≤ 10) more than 48h after stopping sedation * patient without spontaneous or stimulated facial expressions exclusion criteria: * medically unstable patient

Keywords: arousal consciousness disorders vegetative state minimally conscious state
xanthohumol and viral infections (xl)

Conditions: Infection Viral

Summary: the aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections.

in this placebo-controlled study, blood is taken on the first day of the study, followed by a 90-day intervention with xanthohumol or a placebo, which is taken twice daily. blood samples will be taken on day 0, day 45 and day 90. should the study participants develop a respiratory infection during the study, they will be asked to perform a self-test.

Eligibility criteria:
inclusion criteria: * healthy * bmi \>18 kg/m² or \< 28kg/m² exclusion criteria: * food intolerances * food allergies * chronic inflammatory diseases * metabolic diseases * viral or bacterial infections within the last 3 weeks of inclusion * intake of immunosuppressive medication * severe acute respiratory syndrome coronavirus type 2-infection in the last 4 months * influenza infection in the "current" flu season
mdrs for prevention of nocturnal hypoglycemia

Conditions: Type 1 Diabetes

Summary: the investigators have developed a unique remote \& safety diabetes management system (mdrs) that offers real-time remote monitoring and control of glucose levels. the system allows the supervising personal to alarm the patient and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults.the aim of this feasibility study is to evaluate the efficacy of the mdrs system in preventing nocturnal hypoglycemia in children and young adults with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes diagnosed at least 1 year prior to study entry * continuous subcutaneous insulin infusion pump for at least 3 month prior to study entry * use of continuous glucose measurement device for at least one month prior to study entry * age: 4-24 years old * hba1c \< =8.5% * no more than one severe hypoglycemia or an episode diabetic ketoacidosis within the year prior to study entry, and none within the month prior to study entry. * capable of reading a pump screen in english * capable of operating the mdrs software * a patient older than 18 years- leaving routinely with at least one more adult(age above 18 years) capable of connecting the c\&c center and properly reacting to the instructions given by the attending personal. * a patient younger than 18 years- leaving routinely with at least two adults (age above 18 years) capable of connecting the c\&c center and properly reacting to the instructions given by the attending personal. * all participants must provide an adult independent contact person, leaving near by the participant, capable of connecting the c\&c center and properly reacting to the instructions given by the attending personal. this person will be called into action in emergency cases in which the participant or his household members can not be reached. * capable of completing the hypoglycemia the relevant surveys * able to understand and sign an informed consent forms exclusion criteria: * any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study. * patients participating in other device or drug studies * known dermal hypersensitivity to trial products or those that contain medical adhesive * current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication for participation in the study. * inability to understand/complete the hypoglycemia fear survey * female subject who is pregnant or planning to become pregnant within the planned study duration

Keywords: type 1 diabetes continuous glucose monitoring nocturnal hypoglycemia
chitosan nano-hydroxyapatite hydrogel in non-surgical treatment of intrabony defect

Conditions: Chitosan; Nano-hydroxyapatite Hydrogel; Intrabony Defect

Summary: the aim of this study was to evaluate the clinical effect of chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.

periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth. treatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs. chitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. moreover, chitosan has been used for preventing demineralization. ha also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula ca5(po4)3(oh). the oh- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. it crystallizes in the hexagonal crystal system.

Eligibility criteria:
inclusion criteria: * age from 25 to 55 years. * both sexes. * patients with stage ii to iii periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect. exclusion criteria: * patients received periodontal or antibiotic therapy within the previous 6 months preceding the study. * smokers. * pregnant and lactating females. * patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.
safety and efficacy of inhaled insulin in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in the united states of america (usa) and canada. the aim of this research is to compare the efficacy (reduction in hba1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in type 1 diabetes.

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * hba1c less than or equal to 11% * body mass index (bmi) less than or equal to 40.0 kg/m2 exclusion criteria: * total daily insulin dosage more than 100 iu or u/day. * current smoking or smoking within the last 6 months * impaired hepatic or renal function * cardiac problems * uncontrolled hypertension * current proliferative retinopathy or maculopathy requiring acute treatment
the effect of auditory stimuli on heart rate variability (hrv) among patients with acquired brain injury (abi)

Conditions: Acquired Brain Injury

Summary: heart rate variability (hrv) reflects the responsiveness of the autonomic system to an external stimuli. the aim of this system is to maintain homeostasis.the variability implies on the interaction between the sympathetic and the parasympathetic systems to maintain the ongoing changes of the autonomic system. following acquired brain injury (abi), there can be a damage to the central nervous system (cns) function. the damages described in the literature are cognitive, motor and behavioural function, while there is less relation to the autonomic system. the autonomic system can influence the ability of patient with abi to participate in the rehabilitation program. the aim of this work is to investigate the activity of the autonomic system activity as manifested by hrv among patients with abi in different conditions: resting, during activity and while listening to different auditory stimuli.


Eligibility criteria:
inclusion criteria: * 2-4 months from acceptance to rehabilitation medical stable exclusion criteria: * medical unstable a significant hearing deficit premorbid neurological or mental condition

Keywords: acquired brain injury heart rate variability (hrv) auditory stimuli physical activity
healthcare seeking behaviour of primary caregivers for acute otitis media (aom) in children aged 6 months to less than 30 months in panama

Conditions: Infections, Streptococcal

Summary: the study is a survey aiming to describe the healthcare seeking behaviour of primary caregivers when their child aged 6 months to less than 30 months was suspected to have an episode of acute otitis media in panama.

the study is a cross sectional survey in which primary caregivers will be asked if they recall having observed an ear infection in the child in the age range 6 months to less than 30 months in the last 6 months. during the interview, the primary caregivers will be asked what they did for the child during that episode and whether they sought medical care or not. they will be also asked about the demographic characteristics (such as age range) of the child who experienced that episode and the household environment of the child at the time of the episode (such as number of household members), etc. no questions will be asked about the episode itself if the primary caregiver does not recall that the child had one in the last six months. approximately 1300 primary caregivers will be interviewed in multiple clinics / well-baby clinics in panama. the clinics will be stratified into 'former clinical trial sites' and 'non-clinical trial sites' in urban areas of panama, based on participation in the compas trial. both 'former clinical trial sites' and 'non-clinical trial sites' will include private and public facilities. sites will be selected by convenience sampling and eligible subjects will be enrolled on an on-going basis, in proportion to the population coverage of each site. the participating sites have thus been stratified to be able to assess whether the healthcare seeking behaviour of primary caregivers enrolled at former clinical trial sites are different from those enrolled at non clinical trial sites.

Eligibility criteria:
inclusion criteria: * subjects who the investigator/interviewer believes can and will comply with the requirements of the protocol (e.g. availability of time for completion of the interview). * signed informed consent obtained from the subject. * subjects aged 18 years or above, being the primary caregiver of at least one child aged 6 months to less than 30 months, visiting a clinic. note: i. although the child will most likely be present at the time of interview, his/her presence is not required. ii. if more than one primary caregiver fulfilling the inclusion criteria is present per child, only one will be enrolled in this study. exclusion criteria: • subjects having previously participated in this survey.

Keywords: primary caregiver survey acute otitis media ear infection panama healthcare seeking behaviour
comparison of kinesio tape and dry needling for the management of rotator cuff tendinopathy: a randomized control trial

Conditions: Rotator Cuff Tendinopathy

Summary: its a single blind rct

kinesio tape and dry needling were compared for the management of rotator cuff tendinopathy

Eligibility criteria:
inclusion criteria: * age between 25-50 years old * both genders * not any comorbidity exclusion criteria: * parkinson disease * dm * htn
microbial biomarkers of early pseudomonas aeruginosa colonization in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the objective of this study is to evaluate the predictive nature of the biomarker porphyromonas catoniae measured at the age of 12 months in the occurrence of colonization with pseudomonas aeruginosa at 36 months of age in children with cystic fibrosis.

this is a multicentric study in 3 phases: * pre-inclusion: at the first visit to the crcm (support for a positive screening confirmed by sweat test and genotyping cftr) * inclusion: possible between the 2nd visit to the crcm (about 2 months old) and the 6th month * follow-up: up to 36 months old. the pace of visits will be based on the usual follow-up rate of cf infants the clinical data as well as samples (expectorations, stools) will be collected on a monthly basis up to 6 months old and then every 2 months until one year old and finally quarterly until 3 years old. * tracheo-bronchial secretions will be collected at the crcm * stools samples will be carried out by the parents prior to consultation with the crcm * a blood collection will be carried out annually in an annual report.

Eligibility criteria:
inclusion criteria: * infants aged 6 months maximum at inclusion with a confirmed diagnosis of cystic fibrosis in its classical form (positive sweat test and/or two mutations of the cftr gene from class i to iii) * children free from any antecedent of colonization to p. aeruginosa at the time of inclusion (certified by the microbiological history supplemented by a molecular test by qpcr according to the diagram of le gal et al., 2013)-affiliation to the social security system * consent signed by the holders of parental authority or the sole parent holding parental authority / and "oral" agreement of the second holder exclusion criteria: * severe acute pathology (other than cystic fibrosis) in progress, or requiring surgery * children unable to undergo the tests required for the protocol * children whose parent (s) is (are) minor (s) * children whose parental authority does not master the french language * refusal to participate in the study