Kornimate/medical-research-clean huggingface dataset:
leveraging autism intervention for families using telehealth (lift)

Conditions: Autism Spectrum Disorder

Summary: the purpose of the lift study is to develop a technology-assisted adaptation of the jasper (joint attention, symbolic play, engagement, and regulation: kasari et al., 2021) social communication intervention for young children with autism spectrum disorder (asd). in partnership with community early intervention (ei) and early childhood special education (ecse) practitioners in oregon, implementation strategies to help caregivers learn to the use the intervention strategies with their young children will delivered in a pilot randomized trial. the pilot trial will compare primarily self-directed learning through online materials and brief practitioner support (online) with the addition of live synchronous coaching (online + coach) on caregivers' strategy use (primary) and children's joint engagement and social communication (secondary).


Eligibility criteria:
inclusion criteria: * receiving early intervention (ei) or early childhood special education (ecse) services from partnered providers in southern oregon education service district (soesd). * child has received or is awaiting a diagnosis of autism spectrum disorder (asd) exclusion criteria: * child is not receiving services from a partnered educational service district

Keywords: early intervention autism spectrum disorder caregiver implemented adaptive intervention
an integrated and personalized lifestyle approach for people with parkinson's disease

Conditions: Parkinson Disease

Summary: the goal of this study is to investigate the effects of a combined lifestyle program on the quality of life in people with parkinson's disease. participants will be randomly assigned to one of two groups, both receiving standard care, a parkinson lifestyle decision aid and an intake meeting with a lifestyle coach. one group will work on their goals independently, while the other group will get guidance from the lifestyle coach throughout the 12-month program. the program focuses on self-management, exercise, nutrition, sleep and stress. participants will complete questionnaires after 0, 6 and 12 months, and use a wearable sensor for two weeks. the main outcome is quality of life over 12 months, measured with the pdq-39 questionnaire. the study also examines personal goal achievements, symptom changes, and the economic effects of the program.


Eligibility criteria:
inclusion criteria: * parkinson's disease (idiopathic) in all stages of severity * proficient in dutch, for both the data collection (questionnaires) and the intervention (all of the apps/modules are in dutch) * aged 18 or older exclusion criteria: * cognitive impairments that do not allow to fill out the questionnaires, as judged by the researcher during the screening call. * not in possession of or no access to an electronic device that allows for (video) calls with a lifestyle coach, and to complete questionnaires. * planned surgery or a planned major change in healthcare provision.

Keywords: lifestyle personalized stepped care quality of life
a focused registry on the femoral neck system (fns) in patients with femoral neck fractures

Conditions: Femoral Neck Fracture; Hip Fracture

Summary: in comparison to previous implants, the femoral neck system (fns) is an approved implant by the competent authorities (ce mark). it is designated to stabilize medial femoral neck fractures in a minimal invasive technique. the implant combines an angular stable device with screw in screw technology for rotational stability. therefore the purpose of this focused registry is to investigate how the newly developed and approved implant called fns is performing clinically and radiologically in terms of surgical technique, intra- and postoperative complications and short term outcome.

all patients included are treated as per standard or care and followed up from the time point of enrollment until at least three months after surgery as described below. data of a visit after 6 months and 12 months are collected if bone union according to the rush score is not complete after 3 or 6 months respectively or if the patient has persistent or increasing pain on the operated site. preoperative: * patient details * fracture classification and comminution based on ct * pre-fracture hhs and eq5d * x-rays intraoperative: * surgery details * defined intraoperative complications * intraoperative fluoroscopy: hip ap (with leg 15° internally rotated) and lateral after reduction and after implant placement postoperative: * x-ray prior to any mechanical load: hip ap (with leg 15° internally rotated) and lateral 6 weeks and 3 months fu: * defined postoperative complications * hss and eq5d * x-rays

Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of a medial femoral neck fracture (ao/ota 31-b1:3) with the need of a fixation using the fns. * ability to understand the content of the patient information/informed consent form * willingness and ability to participate in the registry according to the registry plan (rp) * signed and dated ethics committee (ec)/institutional review board (irb) approved written informed consent exclusion criteria: * pathological fracture * additional acute fracture * any not medically managed severe systemic disease * recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * pregnancy or women planning to conceive within the registry period * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry

Keywords: hip femoral neck garden classification healing cut-out iatrogenic fracture implant rotational stability minimal invasive
identifying biomarkers and changes in cerebrospinal fluid collected pre and post spinal cord stimulation in subjects suffering from chronic refractory pain conditions

Conditions: Neuropathic Pain

Summary: this is a single center exploratory study in subjects suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (csf). the study aims to identify any form of correlation between biological content of csf and pain/treatment success. the study population include individuals suffering from chronic pain which has not been effectively treated with pharmacological treatment, medical intervention or alternative non-invasive treatments who have been scheduled for spinal cord stimulation.

this is a single centre exploratory study in individuals suffering from chronic refractory pain to identify cellular, molecular and protein biomarkers within cerebrospinal fluid (csf). the investigators aim to identify any form of correlation between biological content of csf and pain/ spinal cord stimulator (scs) therapy success. ' csf will be sampled before and after scs therapy, the samples will be analysed to explore and identify biomarkers that are potentially relevant to the chronic pain conditions . all eligible participants who are enrolled in the study will undergo screening assessment. specifically, assessments will include pain scores assessed by visual analogue scale (vas), quality of life as assessed by the eq-5d, disability as assessed by the oswestry disability index (odi), quality of sleep as assessed by pittsburgh sleep quality index (psqi), pain sensation as assessed by pain map and neuropathic pain as assessed by douleu neuropathique 4 (dn4). during trial implant participants will have csf sample taken using lumbar puncture technique. following collection csf sample will be analysed to identify potential biomarkers. all participants will return to the clinic 14 (± 7) days following the procedure to assess the outcome of their scs trial and complete assessments which include pain map, pain vas, dn4 , psqi , odi , eq-5d and patients global impression of change (pgic). following this participants will be followed up for end of study visit. the second csf sample will be taken at this visit using lumbar puncture technique. at this visit participants will further be asked to complete assessments including pain map, pain vas, dn4 , psqi , odi ,eq-5d and pgic.

Eligibility criteria:
inclusion criteria: 1. be capable of understanding and signing a written consent form 2. subjects suffering from chronic neuropathic pain which has not been effectively managed with pharmacotherapy, medical interventions or alternative non-invasive treatments 3. pain vas score ≥ 5 on more than 3 days a week at least over three months. 4. subjects deemed a suitable candidate receive spinal cord stimulator device as determined by a pain management specialist 5. no known contraindication to spinal cord stimulation 6. does not have an active systemic or local infection exclusion criteria: 1. structural abnormalities of the spine at l2-l3 that may impact study procedure 2. severe scoliosis
cardiac mri in ischemic stroke study

Conditions: Stroke

Summary: the purpose of this prospective single-center trial is to compare the safety and diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging and transesophageal echocardiography in patients with acute ischemic stroke.

primary safety objective: contrast medium-enhanced cardiac magnetic resonance imaging is safe in patients with acute ischemic stroke. primary outcome: the diagnostic value of contrast medium-enhanced cardiac magnetic resonance imaging is comparable to transesophageal echocardiography in patients with acute ischemic stroke.

Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke detected by brain magnetic resonance imaging. exclusion criteria: * known atrial fibrillation or cardiac source of embolism * severe aphasia * acute infection or chronic inflammation * severe arteriosclerosis or stenosis of brain-supplying arteries * contraindications for magnetic resonance imaging or transesophageal echocardiography.

Keywords: mri
a study of nivolumab plus bempegaldesleukin (bempeg/nktr-214) vs nivolumab alone vs standard of care in participants with bladder cancer that may have invaded the muscle wall of the bladder and who cannot get cisplatin, a type of medicine given to treat bladder cancer

Conditions: Bladder Cancer; Bladder Tumor; Muscle-Invasive Bladder Cancer

Summary: the purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.


Eligibility criteria:
inclusion criteria: * urothelial carcinoma (uc) of the bladder, clinical stage t2-t4an0, m0 or t1-t4an1, m0, diagnosed at transurethral resection of bladder tumor (turbt) * must be deemed eligible for radical cystectomy (rc) by urologist, and must agree to undergo rc. for arms a and b, participants must agree to undergo rc after completion of neoadjuvant therapy. * eastern cooperative oncology group (ecog) performance status 0 or 1 * cisplatin-ineligible participants will be defined by any one of the following criteria: i) impaired renal function (glomerular filtration rate \[gfr\] ≥ 30 but \< 60 ml/min) ii) gfr should be assessed by direct measurement (ie, creatinine clearance) or, if not available, by calculation from serum/plasma creatinine (cockcroft-gault formula) iii) common terminology criteria for adverse events (ctcae) version 5, ≥ grade 2 hearing loss (assessed per local soc). iv) ctcae version 5, ≥ grade 2 peripheral neuropathy. * documented left ventricular ejection fraction (lvef) more than 45% exclusion criteria: * clinical evidence of ≥ n2 or metastatic bladder cancer * prior systemic therapy, radiation therapy, or surgery for bladder cancer other than turbt or biopsies is not permitted. prior bacillus calmette-guerin (bcg) or other intravesicular treatment of non-muscle invasive bladder cancer (nmibc) is permitted if completed at least 6 weeks prior to initiating study treatment. * evidence of urothelial carcinoma (uc) in upper urinary tracts (ureters or renal pelvis) or history of previous mibc * history of pulmonary embolism (pe), deep vein thrombosis (dvt), or prior clinically significant venous or non-cva(cerebrovascular accident)/tia (transient ischemic attack) arterial thromboembolic event * known cardiovascular history, including unstable or deteriorating cardiac disease within the previous 12 months (including unstable angina or myocardial infarction, congestive heart failure or uncontrolled clinically significant arrhythmias) other protocol-defined inclusion/exclusion criteria apply

Keywords: immunotherapy nktr-214 nivolumab bempeg
pain with differing insufflation pressures during laparoscopic hysterectomy

Conditions: Post Operative Pain

Summary: the purpose of this study is to determine the effect of decreased insufflation pressure on postoperative pain, analgesic use, and surgical safety and feasibility for laparoscopic hysterectomy.

this is a prospective, single-blinded, randomized clinical trial in which participants undergoing laparoscopic hysterectomy will be randomized in a 1:1 ratio to undergo surgery with peritoneal insufflation pressure set to 15 mmhg (standard) or 12 mmhg (comparison). randomization was performed using computer-generated permuted blocks of four participants. all participants on the first postoperative day will be asked to rate their pain with a visual analog scale (vas). at a postoperative visit 2 weeks after surgery, all participants will be asked to complete the vas again. the highest preoperative pain (up to 2 hours before surgery) and immediate postoperative pain, using the vas, in the post anesthesia care unit (pacu) will be recorded. all participants will be planned for discharge from pacu. age, body mass index, gynecologic diagnosis, medical history, and preoperative analgesia or opioid use will be extracted from the medical records by trained research staff and entered into a secure electronic database. preoperative analgesia and opioid saw will be verified with active prescription records at the time of surgery. after surgery, analgesic doses, operative time, additional procedures performed, conversion to laparotomy or increased insufflation pressure, estimated blood loss, and length of stay will be recorded.

Eligibility criteria:
inclusion criteria: * women aged 18 to 80 * bmi 55.0 or less * laparoscopic hysterectomy surgery planned exclusion criteria: * women younger than 18 or older than 80 years of age * bmi over 55.0 * laparoscopic hysterectomy surgery not planned
shear wave elastography in differentiating acute or chronic kidney disease

Conditions: Elastography; Chronic Kidney Diseases

Summary: chronic kidney disease is a common global public health issue and its prevalence increased year by year. early diagnosis and intervention can prevent further complications and comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve the patients' life quality. to differentiate acute from chronic kidney disease was crucial especially in the setting of crowded and high-risk emergency department. to diagnose acute or chronic kidney disease, physicians usually use blood sample test combined with image studies such as conventional sonography, ct and mri. however, there was lots of limited factors. the patients may have no previous visit records, poor renal function to receive contrast medium, or critical clinical condition to undergo time-wasting exam. although the conventional renal sonography is accessible and inexpensive, the judgement is subjective and provide little clinical information. recent researches of shear wave elastography in evaluating renal parenchymal stiffness showed some correlation with nephropathy. in our study, aiming to facilitating clinical implication, the investigators will use swear-wave elastography combined with conventional renal sonography to benefit patients in diagnosis of acute or chronic kidney disease.

this is a case-control study. the investigators obtained data from participants who were older than 20 years old and received renal sonography examination in the emergency department of national taiwan university hospital. the investigators examined the participants' kidneys by recording the kidney size, cortical thickness, possible lesions and elasticity by shear-wave elastography. these data combined with the participants' medical history and renal function revealed by blood examination will be analyzed. this study was designed to determine the correlation between renal cortical elasticity and chronic kidney disease.

Eligibility criteria:
inclusion criteria: * the patients older than 20 years old who needed to receive renal sonography in emergency department of national taiwan university hospital. exclusion criteria: * the patients who didn't obtain agreement. * the patients who can't cooperate or follow the directions
immediate implant with provisionalization

Conditions: Maintain the Esthetic

Summary: prospective observational clinical study conducted to evaluate the success of graftless immediate implantation with provisionalizaion

in this study 35 graftless immediately placed implant in smile line loaded by provisional office made restoration, the primary and secondary stability measured and compared in addition to evaluation of pink esthetic score

Eligibility criteria:
inclusion criteria: 1. medical and psychological fitness for minor oral surgery. 2. age 20-60 years. 3. medium to thick gingival biotype. 4. buccal plate thickness more than (1mm). exclusion criteria: 1. smoking habit. 2. diabetes mellitus. 3. a systemic disorder that is contraindicated for the minor surgical procedure. 4. pregnancy or lactation. 5. any irradiation in head and neck area. 6. need for bone augmentation procedure. 7. clinical signs of bruxism or other severe functional disorders. 8. patient with periodontal disease.
surgery in addition to the medical treatment of lymphedema

Conditions: Optimal Treatment of Lymphedema

Summary: lymphedema is a chronic pathology with a real impact on the quality of life of patients. despite optimal medical management of patients, some patients still have no pitting edema on which the medical treatment has no effect. it is adipose tissue secondary to the evolution of lymphedema. it is often painful and important in terms of volume with the resulting functional consequences. the investigators propose to these patients a surgical management complementary to the optimal medical treatment by microlipoaspiration associated or not with a dermolipectomy. this surgical management began in 2014 in our service. the investigators want to evaluate the impact on quality of life of patients in this surgical management in addition to medical care.

detailed description: this is a monocentric, observational cohort study. main judgment criteria: evolution of the quality of life score of the lymqol self-questionnaire between preoperative and postoperative (at 3.6 and 12 months) the investigators used a french translation of keeley's lymqol (quality of life measure for limb lymphoedema) self-administered questionnaire in 2010 (2) to assess the quality of life of patients. this is a lymphedema specific questionnaire for which there is one version for the upper limb and one for the lower limb. limb function, lymphedema symptoms, body image and mood are assessed independently. it allows to obtain a score between 1 and 4 which corresponds to the discomfort felt. the higher the score, the better the quality of life. it also includes, in the last question, a numerical scale allowing the patient to note her quality of life between 0 and 10. since 2016, patients have systematically completed quality of life questionnaires. perimeter measurements are also done systematically at each visit, these data are available in the patient's computerized medical records (dx care). secondary judgment criterion: difference in the volume of the limb operated between preoperative and postoperative (3, 6 and 12 months) the volume is calculated on the basis of stepped circumferential measurements (every 10 cm starting from the patella for the lower limb and every 5 cm starting from the bend of the elbow for the upper limb). these measures are taken at each consultation by our physiotherapists, specialized nurses or vascular doctors. it is therefore a question of retrospectively analyzing the data collected. the data will then be anonymised by a two-letter code and a number and will be entered on a excel file available on a secure directory of the chu for analysis. a dedicated support protocol is already implemented in the cf appendix service. there are no special modalities for patients not included in the study.

Eligibility criteria:
inclusion criteria: * no pitting edema * good therapeutic compliance * weight stability exclusion criteria: - under 18 years old

Keywords: no pitting edema after medical and surgical evaluation microlipoaspiration surgery lymphedema
external validation of prediction algorithm using non-invasive monitoring device for intraoperative hypotension

Conditions: Hypotension During Surgery

Summary: the goal of this prospective observational study is to externally validate the prediction algorithm using non-invasive monitoring device for intraoperative hypotension. the main question it aims to answer is: does the prediction algorithm predict intraoperative hypotension effectively?

the hypotension that occurs during surgery is associated with the poor prognosis of patients after surgery. previous studies have reported that even a short period of time of hypotension increases the risk of postoperative complications such as kidney injury. if anesthesiologists can predict intraoperative hypotension in advance, they can prevent or minimize the damage. recently, there are many reports on medical artificial intelligence models that predict the intraoperative hypotension. among them, the hypotension prediction index (hpi) model has already been commercialized and used in clinical practice. however, hpi has limitations in that it is necessary to perform invasive techniques (arterial cannulation) or to use dedicated equipment at high cost. however, since many of the general anesthesia are performed without invasive monitoring devices, the use of hpi medical devices is subject to considerable restrictions. the investigators have reported the prediction algorithm for intraoperative hypotension using five non-invasive monitoring devices commonly used in general anesthesia: 1) blood pressure (nbp, number), 2) electrocardiogram (ecg, waveform), 3) end-oxygen saturation waveform (ppg, waveform), 4) end-stage carbon dioxide waveform (etco2, waveform), and 5) an anesthesia depth (bis, number) by conducting a retrospective external validation process using public clinical data from other institutions (tertiary hospital in korea), the final model was able to have good predictability with an area under the receiver-operating characteristic curve (auroc) value of 0.917. however, investigators did not externally validate that algorithm through a prospective designed study. this study intends to externally validate the "hypertension prediction model during surgery using non-invasive monitoring device", which has already reported it is expected that the usefulness and limitations of the prediction model can be evaluated again, and the model can be advanced based on the results.

Eligibility criteria:
inclusion criteria: * adults patients aged 19 or more * elective surgery under general anesthesia * american society of anesthesiologists physical status i - iii exclusion criteria: * vasopressor/inotrope usage before surgery * patients who needs invasive arterial cannulation * emergency surgery * pregnant or lactating women

Keywords: intraoperative hypotension prediction algorithm