Kornimate/medical-research-clean huggingface dataset:
a study in participants with acute major bleeding to evaluate the ability of andexanet alfa to reverse the anticoagulation effect of direct and indirect oral anticoagulants (extension study)

Conditions: Bleeding

Summary: the purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor xa (fxa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. the safety of andexanet was also studied.


Eligibility criteria:
key inclusion criteria: 1. acute major bleeding episode that required urgent reversal of anticoagulation; defined by at least one of the following: * acute bleeding that was potentially life-threatening, or * acute bleeding associated with a fall in hemoglobin level by ≥2 grams/deciliter (g/dl), or * acute bleeding associated with a hemoglobin level of ≤8 g/dl if no baseline hemoglobin was available, or * acute bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial. 2. if bleeding was intracranial or intraspinal, the participant must have undergone a head computed tomography (ct) or magnetic resonance imaging (mri) scan demonstrating the bleeding. 3. participant received or was believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban, or enoxaparin. 4. for participants with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation. key exclusion criteria: 1. the participant was scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures. 2. participant with an intracerebral hemorrhage that had any of the following: * glasgow coma score \<7, or * intracerebral hematoma \>60 cubic centimeters as assessed by ct or mri 3. participants with visible, musculoskeletal or intra-articular bleeding as their qualifying bleed. 4. expected survival of less than 1 month. 5. recent history (within 2 weeks) of a diagnosed thrombotic event as follows: venous thromboembolism, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris hospitalization or severe peripheral vascular disease within 2 weeks prior to screening. 6. severe sepsis or septic shock at the time of screening. 7. pregnant or a lactating female. 8. participant received any of the following drugs or blood products within 7 days of screening: * vitamin k antagonist * dabigatran * prothrombin complex concentrate (pcc) products or recombinant factor viia (rfviia) * whole blood, plasma fractions 9. treated with an investigational drug \<30 days prior to screening. 10. planned administration of pcc, fresh frozen plasma or rfviia from screening until within 12 hours after the end of the andexanet infusion.

Keywords: factor xa inhibitors major bleeding anticoagulant major bleeding andexanet alfa reversal agent
oral health related quality of life in cad metallic and poly ether ether ketone (peek) partial denture frameworks in mandibular kennedy class i cases

Conditions: Partial Edentulism; Oral Health-Related Quality of Life

Summary: the aim of this study was to compare cad poly ether ether ketone (peek) rpd to cad metallic rpd in treating partial edentulism in terms of oral health related quality of life


Eligibility criteria:
inclusion criteria: * patients with bilateral free end saddles in the mandible (kennedy class i) with the last standing abutment second premolar * opposing dentition is fully intact or restored to be intact * adequate inter-arch space of at least 7mm * angle's class i maxilla-mandibular relationship * patients with no periodontal disease and good oral hygiene * cooperative patients showing motivation to follow-up exclusion criteria: * periodontal affection of the abutment teeth * skeletal mal-relationship * unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- patients with neuro-mascular disorders * systemic disease affecting periodontal health like uncontrolled diabetes

Keywords: cad/cam digital metallic rpd patient centered outcomes 3d printing peek ohip-14
mri maker of perioperative neurocognitive disorder

Conditions: Necrosis of Femoral Head; Knee Osteoarthritis; Fracture of Lower Limb

Summary: periperative neurocognitive disorder(pnd) is consistently associated with increased morbidity and mortality, but its mechanisms remain unclear. moreover, valid biomarkers for the prediction or diagnosis of the development of delayed neurocognitive recovery in aged patients have not been identified so far. the purpose of this study is trying to find the functional mri marker of pnd.


Eligibility criteria:
inclusion criteria: * age ≥ 60 years * spoke proficient chinese * selected to lower limb osteopathic surgery * informed consent signed by the patient * underwent general anesthesia exclusion criteria: * existing cerebral disease, or have a history of neurological and psychiatric diseases including ad, stroke, and psychosis * existing cognitive impairment as evidenced by mini-mental state examination scores below 24 * several audition or vision disorder * with standard contraindications to mri examinations * unwillingness to comply with the protocol or procedures.
l-c ligament versus hamstring autograft for primary acl reconstruction

Conditions: Acute Ruptures of the Anterior Cruciate Ligament

Summary: the purpose of this study is to compare safety and efficacy outcomes of the l-c ligament versus hamstring autograft for treatment of acute rupture of the acl.


Eligibility criteria:
inclusion criteria: * patients with acute ruptures of the acl who are willing to undergo treatment within 18 weeks of injury exclusion criteria: * prior acl reconstruction or other surgical procedure on the affected (target) knee * chronic acl injury; interventional surgery scheduled 127 days or more after acl injury * professional athletes currently engaged in active sport * prior distal femoral and/or proximal tibial fracture(s) of the target leg * previous or current acl injury on contra-lateral leg * multi-ligament reconstruction * malalignment or varus thrust * patient \> 193 cm tall (6' 4") * the patient does not follow pre-operative rehabilitation that may have been prescribed post-injury (prior to index procedure) * confirmed connective tissue disorder * signs of moderate to severe degenerative joint disease * severe pain, swelling, or redness within 24 hours prior to surgery * complete or partial posterior cruciate ligament (pcl) tear * if concomitant meniscal injury is present, any of the following: 1/3rd meniscal resection; complex double-bucket tear; partially repaired meniscal tears * any type of lateral and/or medial meniscal tear which is not repairable (\<2mm from rim) * additional concomitant injuries to the knee or lower extremities requiring treatment, per surgeon's discretion, that are not allowable under the inclusion criteria * the patient is unwilling to not participate in sporting activities for at least 9 months post-procedure * the patient is mentally compromised * the patient has a neuromuscular disorder that would engender unacceptable risk of knee instability, prosthesis fixation failure, or complications in postoperative care * the patient has an active or latent infection in or about the affected knee joint or an infection site distant from the knee that may spread to the knee hematogenously * pregnant based on a positive beta hcg serum or an in vitro diagnostic test result or breast-feeding * the patient is obese with a bmi \> 35 * the patient has a known allergy to plla * the patient has a medical condition or comorbidity that would interfere with study participation

Keywords: acl knee injury anterior cruciate ligament
a hypoallergenicity study on a new rice-based hydrolysate formula

Conditions: Allergy;Food

Summary: cow's milk allergy (cma) affects between 2-3% of young children but its severity varies between regions/countries. while the long-term prognosis for cma is good, with the majority (80-90%) of children outgrowing their allergy by around 3-5 years. breast feeding is the most optimal form of feeding for all infants, regardless of their condition, and in those with cma maternal dairy exclusion is recommended as first line treatment. in non-breast fed or mixed feeding, a hypoallergenic milk substitute is recommended for young infants. the aap and other societies such as eaaci and espghan considers a formula to be 'hypoallergenic' if at least 90% of children with documented cma tolerate it, with a 95% ci, under double-blind, placebo-controlled conditions.this equates to at least 29 children who should tolerate the product following blind and open challenge.

a prospective, multi-centre double blind randomised placebo-controlled study to demonstrate the safety and tolerance of a new rice-based hydrolysate in children with diagnosed cow's milk allergy (cma). the test product being a new milk substitute hydrolysed rice-based formula with new ingredient. the results will satisfy the safety requirement when tolerated by 90% of children with proven cma, with a confidence of 95%. new, and previously diagnosed children with confirmed cma who meet the inclusion criteria will be eligible to participate in the study. those included in the intervention phase will have ige testing and an oral food challenge (ofc) to test and placebo products, in a randomised double-blind design. children with a negative reaction to both test and placebo products will receive the test product for a period of 7 days (open challenge).

Eligibility criteria:
inclusion criteria: 1. children \<10 yrs of age 2. proven ige-mediated cma 3. \>2500g at birth 4. \> 37 weeks gestation 5. written informed consent provided by parent(s)/guardian exclusion criteria: 1. infants/children with severe concurrent illness (other than food allergy/cma) 2. investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements. 3. participation in other studies involving use of milk replacement products designed to treat/manage cma within two weeks prior to entry into this study 4. current participation in oit to cow's milk 5. diagnosis of anaphylaxis to cow's milk 6. diagnosis of rice allergy

Keywords: cow's milk protein allergy (cmpa) cow's milk allergy (cma) children
spinal versus general anesthesia on postoperative pulmonary complications

Conditions: Pulmonary Complication; Anesthesia; Hip Fractures

Summary: the objective of this study was to investigate the difference in postoperative pulmonary complications (ppcs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery.

in this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. by means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared.

Eligibility criteria:
inclusion criteria: * patients ≥ 65 years old * asa class i \~ iii * surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures * the time from diagnosis to surgery is more than 48 hours exclusion criteria: * unable to walk about 3 meters or across a room without assistance before the fracture * emergency surgery * congestive heart failure, asthma, anemia (hb \< 90 g/l), hypoalbuminemia (alb \< 35g/l) * abnormal coagulation function * severe aortic stenosis * injection site infection or increased intracranial pressure * patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization * the written informed consent of the patient or his/her representative cannot be obtained

Keywords: hip fracture delayed surgery pulmonary complication spinal anesthesia general anesthesia
a study of vorinostat in patients with solid tumors (mk-0683-029)

Conditions: Tumors

Summary: the primary purpose of this trial is to determine the maximum tolerated dose (mtd), or the maximum acceptable dose (mad) and evaluate the dose limiting toxicity (dlt) of oral suberoylanilide hydroxamic acid in participants with solid tumors.


Eligibility criteria:
inclusion criteria: * participants with histologically or cytologically diagnosed solid tumor; no standard therapy available or participant has failed to respond to standard therapy exclusion criteria: * participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens. * any uncontrolled concomitant illness * are pregnant or breast-feeding * serious drug or food allergy

Keywords: solid tumors
effect of robotic treatments on motor functions in subacute stroke patients

Conditions: Stroke

Summary: we are conducting a three-group comparative study on stroke patients. the treatment is started in a subacute state and completed in the hospital. the essence of robot-assisted treatments is faster recovery and better learning to walk. the group will do a special walking exercise with a robot. the walking group does the same training, only without robotic assistance. the control group will receive physiotherapy treatments financed by the state. control examination after 3 weeks.


Eligibility criteria:
inclusion criteria: post stroke 6mwt : 120\> minimum after stroke 3 days be a stroke patient first stroke hemiplegia exclusion criteria: multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid alcohol sever heart problem sever demeanor alcoholism drug problems drug

Keywords: robotic stroke rehabilitation
assessment of the safety and the performance of the sagitta evl r stems in hip arthroplasties

Conditions: Hip Arthropathy

Summary: total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. revision risk factors reported when considering the main surgical approaches. studied from the dutch arthroplasty registry found a revision rate in hemiarthroplasty (ha) of 1.6% at 1 year and 2.5% at 5 years postoperatively. for total hip replacement (tha), the rate was 2.4% at 1 and 4.3% at 5 years postoperatively. analyze shows that the risk factors for hemiarthroplasty were male sex, age under 80 (regardless of gender), posterolateral approach and uncemented fixation. the risk factors for hat were exactly the same, but they found that smoking also played a role. it should be noted that age as a risk factor for revision is not a risk during the first year after the fracture, but becomes one in the years that follow. in order to maintain compliance with the directive on medical devices (93/42 / eec \[m5\]) and the future regulation (eu) (2017/745) relating to medical devices, serf has set up post-market clinical follow-ups ( pmcf). this pmcf study aims to improve knowledge related to the performance, safety and benefit / risk ratio of the sagitta evl-r stem and to monitor patient care strategy through this clinical evaluation. significant clinical results as well as safety must be confirmed with this patient cohort. it is important to note that this cohort reflects the specific care strategy of the university hospital of poitiers. therefore, the strategy could be different between hospitals and countries.


Eligibility criteria:
inclusion criteria: * patients over 18 years old. * patients that were treated with the sagitta evl-r stem for an indication of arthroplasty and according to the instruction for use (ifu). * primary or secondary arthrosis, * advanced joint destruction resulting from rheumatoid arthritis or traumatic arthritis, * a fracture or an avascular necrosis, * following a previous surgical operation, on condition that the new device does not interfere with the material in place. * indicated in the case of primary or secondary arthrosis, displaced sub-capital or transcervical fracture as well as stages i and iib bone loss according to the paprowski classification. * the sagitta evolution for revision implant is recommended for indications according to the bone loss classifications of sofcot stages i to vi, paprosky types i to vi and the aaos types ia to ic. * dysplasia exclusion criteria: * patient presenting a contraindication indicated in the ifu.
double plating versus single plating techniques in midshaft clavicle fractures

Conditions: Clavicle Fracture

Summary: the goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. the main question it aims to answer is: 1. does low profile double plating of midshaft clavicle fractures with one 2.0mm plate and a second 2.4 or 2.7 mm plate lead to a lower rate of re-intervention when compared to either single superior or single anterior plating?

clavicle fractures account for 2% to 5% of all fractures in adults, with a majority of patients being young and active. a gold standard for the treatment of clavicle fractures has yet to be established, but single plated surgical intervention is most widely used. in recent years a smaller double plating technique has been described as a possible solution to the high removal rates associated with single plating. in (orthopaedic) surgery however, randomized controlled trials (rcts) are recognized for their limitations. although rcts are considered the gold standard for testing the efficacy of new interventions, randomisation and blinding can be challenging. simultaneously, there is an inclination for the usage of rcts in clinical protocols, frequently based on the credo that it is the only valid method of comparing treatments. a natural experiment (ne), or quasi-experiments, in which groups are compared by nature of factors outside the control of the investigator (i.e. different surgical techniques between centres), offers a possible solution for methodological quality control. this study aims to increase the knowledge on surgical outcomes for single vs double plating in midshaft clavicle fractures following a natural experiment design.

Eligibility criteria:
inclusion criteria: * 18 years and older * primary mid-shaft clavicula fracture defined as the middle third of the clavicle (robinson type ii or ao 15.2) * patients that are eligible for operative treatment of clavicle fractures. generally accepted indications include: * displacement of one or more shaft width * shortening of more than 1cm in length * high demand patients (physical activity) exclusion criteria: * delayed presentation (\> 14 days) * initial operative treatment at non-participating hospitals * open fractures * pathological fractures * re-fractures of clavicle * concomitant ipsilateral injury of upper extremity (including but not limited to shoulder, scapula, and ribs) * cognitive impairment or language barrier precluding answering questionnaires * unable to complete follow-up (e.g. different residential area/tourists)

Keywords: clavicle/injuries bone plates non-randomized controlled trials as topic
the effect of magnetic stimulation on low back pain relief and muscle mass maintenance in patients with esrd

Conditions: End-Stage Renal Disease

Summary: to determine the effectiveness of magnetic stimulation application on alleviating back pain and maintaining muscle mass in patients with end-stage renal disease.


Eligibility criteria:
inclusion criteria: 1. adults aged 19 years or older 2. patients diagnosed with end-stage renal failure and receiving dialysis treatment more than three times a week 3. back pain intensity of 4 points or higher on the visual analogue scale (vas) 4. those with cognitive function that can clearly indicate nrs with a score of 23 points or higher, the criterion for determining cognitive impairment on the mini mental state examination (mmse) \[14\] 5. those who voluntarily decided to participate in this clinical trial after receiving a detailed explanation and fully understanding it and gave written consent to comply with the precautions exclusion criteria: 1. if the pain is due to trauma 2. if it is difficult to participate in the study due to serious mental illness (e.g. schizophrenia, bipolar disorder, etc.) or psychological instability. 3. patients with severe neurological illness (e.g. stroke, severe dementia, etc.). 4. those with poor general condition due to unstable cardiovascular, digestive, respiratory, or endocrine systems, or severe internal medical illness such as systemic infection 5. patients participating in other therapeutic clinical trials or those who have participated in other therapeutic clinical trials within the past 30 days (observational studies are not relevant) 6. if there are contraindications to magnetic stimulation * patients with implanted medical devices (e.g. pacemakers) * metal objects are inserted into the skull * a wound on the skin at the attachment site * history of epilepsy * cervical pain or musculoskeletal disease * pregnant and lactating women
exercise and body composition in juvenile idiopathic arthritis

Conditions: Arthritis, Juvenile

Summary: this research is being done to see if resistance exercise (re) is safe and has a positive effect on children and young adults with juvenile idiopathic arthritis (jia). jia is an inflammatory autoimmune disease that can cause severe impairment and disability. jia can cause bone loss and decreased muscle strength. the medications used to treat jia can also have negative effects on growth and development, strength, and ability to function. re is performing movements in a slow and controlled fashion (i.e., no speeding up or using force in the lifting and lowering of the weight) to lessen force on the joints and tissues. this study will be using ren-ex exercise equipment to perform re. currently the american college of rheumatology recommends exercise for patients with arthritis. this exercise includes range of motion exercise to protect joint mobility as well as low resistance and aerobic exercise (ae) to protect muscle mass, bone health, and fitness. however, a recent study showed no major differences in functionality or quality of life between patients who performed ae and those who did not perform ae. there is a need for more data on the impact of re on children with jia. children and young adults aged 10 to 21 with juvenile idiopathic arthritis may join.


Eligibility criteria:
inclusion criteria: * american college of rheumatology criteria for polyarticular jia * stable medical therapy exclusion criteria: * non-english speaking * pregnancy * currently breast feeding * cognitive impairment as determined by pi (patient is not responsible for making their own health care decisions)