Kornimate/medical-research-clean huggingface dataset:
correlation physiological cost index

Conditions: Cerebral Palsy

Summary: objective: to compare the efficacy of a gait training program using robotic assistance combined with virtual reality versus robotic assistance alone on energy expenditure in children with cerebral palsy. participants: children with cerebral palsy levels ii, iii, iv, and v according to the gross motor function classification system (gmfcs), from different paediatric physiotherapy centres and schools in valencia, spain. intervention: gait training using an inexpensive robotic gait training system (cl1walker) and participation in a virtual reality game, treasure hunt (abbreviated here as act, from the spanish a la caza del tesoro) in the experimental group (gtvr) and gait training using the same robotic gait training system without using virtual reality in the control group (gt). measurements: assessment using the physiological cost index (pci) one week prior to and after the intervention. the intraclass correlation (icc) replicability and the minimum detectable change (mdc) of the pci.

design: longitudinal, prospective, double blind study with two treatment groups and repeated measurements, controlled for the condition without virtual reality.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebral palsy * must be able to follow the instructions and participate in the game exclusion criteria: * orthopaedic surgery in lower limb * botulinum toxin in lower limb

Keywords: physiological cost index health-related quality of life gait deviation index gait analysis cerebral palsy
post market clinical follow-up study protocol for procotyl® c acetabular components

Conditions: Joint Disease

Summary: microport orthopedics (mpo) is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of its total hip arthroplasty (tha) components marketed in the european union (eu). these types of studies are required by regulatory authorities for all tha devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in europe. this study has been designed in accordance with the medial device directives (meddev) 2.12/2 rev 2.


Eligibility criteria:
inclusion criteria: to be included in the study, subjects must meet all of the following criteria: * has previously undergone primary total hip arthroscopy for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia; * inflammatory degenerative joint disease such as rheumatoid arthritis; * correction of functional deformity * subject was implanted with the specified combination of components, namely, any microport orthopedics or wright medical technology femoral stem and procotyl c acetabular components * subject is willing and able to complete required study visits or assessments previously implanted bilateral subjects can have both thas (total hip arthroscopy) enrolled in the study provided: 1. the specified combination of components were implanted in both, 2. all other aspects of the inclusion/exclusion criteria are satisfied, 3. enrollment does not exceed the subject count specified in the clinical trial agreement, and 4. the subject agrees to a second informed consent document specific to the second tha. prospective enrolment of a previously unimplanted hip is not permitted in this study. exclusion criteria: subjects will be excluded if they meet any of the following criteria: * subject was skeletally immature (less than 21 years of age) at time of implantation * subject has a non-microport or non-wright medical technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled total hip arthroscopy * subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol * subject is unwilling or unable to sign the informed consent document * subject has documented substance abuse issues * subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study * subject is currently incarcerated or has impending incarceration

Keywords: osteoarthritis avascular necrosis ankylosis protrusio acetabuli painful hip dysplasia rheumatoid arthritis correction of functional deformity
patient-specific techniques for hip replacement

Conditions: Hip Arthritis; Hip Arthropathy

Summary: background * in the 19th century, sir john charnley successfully introduced total joint replacements for hips. in order to prevent implant fixation failure and accelerated polyethylene wear, it was initially recommended that implants were systematically positioned in a "biomechanically-friendly" way, which disregarded most of the individual anatomy (medialized acetabular cup, systematized cup version and inclination, etc.) * while those initial surgical techniques made popular and clinically successful total joint replacements, many complications (aseptic loosening, pain, excessive wear) have remained and mainly the persistence of frequent instability after tha. in response to those complications, many improvements were developed in the area of joint replacement over the last few decades, with one the most recent dating from 2017 and being the development of a surgical technique rationale * the kinematic alignment (ka) technique for total hip arthroplasty (tha) aims at restoring the acetabular center of rotation and as much as possible the constitutional acetabular anteversion by using the transverse acetabular ligament (tal) as a reference landmark. also, the technique aims (1) at making personalized choice for the hip component design, (2) at defining the cup positioning, and (3) at sometimes considering additional spine surgery based on the assessment of the individual spine-hip relation. * ka techniques for hip replacements are relatively new, likely to become popular over time, and their true value remains to be determined.

* objective: evaluation of the kinematic alignment technique for hip prostheses in patient with hip osteoarthritis * hypothesis: the consideration of hip pathoanatomy and lumbo-pelvic kinematic disorder when planning a hip replacement is likely to decrease the risk of prosthetic dislocation and improve patient function and satisfaction

Eligibility criteria:
inclusion criteria: * osteoarthritic hip patients eligible for primary total hip arthroplasty (thr). * \> 18 years-old with no upper age limit * affiliated to a social security scheme exclusion criteria: * pregnant or lactating women or in age to procreate without contraceptive treatment * history of mental illness or neurological deficit or adults lacking capacity to consent for themselves * prisoners or young offenders * persons who might not adequately understand verbal explanations or written information given in french, or who have special communication needs * subjects having been or being frequently x-ray examination * heart failure with risk of exercise angina or comorbidity(ies) significantly affecting patient function * any participants who are involved in current research or have recently been involved in any research prior to recruitment.

Keywords: hip arthroplasty spine hip relation
positive psychology for physical activity promotion

Conditions: Obesity; Physical Activity

Summary: this study is for physically inactive adults. participants will be enrolled in the positive psychology and physical activity intervention designed to help them overcome barriers to physical activity, based on the principals of positive psychology. this will involve six weekly one-hour group-based sessions at a local ymca with a trained group leader. in addition to the in-person sessions, there will be text messages sent to participants about physical activity that include positive psychology content.

the investigators propose to conduct a pilot study to test feasibility and proof-of-concept for a positive psychology intervention program to promote exercise among low-active overweight and obese adults. the program will be (a) a 6-week, group-based intervention, (b) delivered at local ymcas, and (c) supplemented with text messaging. in an additive design, participants will be randomized in a 2:1 ratio to pppa (n = 40) versus a control intervention (n = 20) including only the standard pa promotion components of the pppa intervention (i.e., pa education, self-monitoring, and goal-setting), with equal frequency of staff contact and text message delivery. all participants will be followed for 3 months, and will receive a 3-month ymca membership to equate access to pa facilities. as a secondary aim the investigators will examine effect sizes for pppa versus the standard pa intervention on putative mediators that may underlie the efficacy of pppa in improving pa outcomes, including positive and negative affect, optimism, happiness, life satisfaction, social support for pa, and pa enjoyment. the proposed research will set the stage for an rct to test a novel pa promotion intervention that can be readily disseminated.

Eligibility criteria:
inclusion criteria: * sedentary or low-active, (defined as \< 60 min/week of structured physical activity) * able to receive and respond to a text message at the time of screening exclusion criteria: * history of coronary artery disease * history of stroke * history of uncontrolled hypertension * history of asthma * history of chronic obstructive pulmonary disease (copd) * history of diabetes * history of osteoarthritis or orthopedic problems that limit physical activity * bmi greater than 40

Keywords: positive psychology affect
a study to compare pk/pd characteristics and safety profiles between ad-212-a and ad-2121

Conditions: Gastro Esophageal Reflux

Summary: primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of ad-212-a in healthy subjects.

the purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of ad-212-a compared with ad-2121 in healthy subjects.

Eligibility criteria:
inclusion criteria: * body weight equal to or greater than 50kg and body mass index (bmi) between 18.5 kg/m2 and 27.0 kg/m2 at the time of screening visit * the age equal to or greater than 19 in healthy volunteers at the time of screening visit * negative result from serum helicobacter pylori antibody at the time of screening visit exclusion criteria: * patients with trouble performing gastric ph monitoring
bimatoprost versus travoprost at cairo university

Conditions: Glaucoma; Ocular Hypertension

Summary: bimatoprost has been shown to provide effective iop lowering in patients of all races. conversely, travoprost has been shown to be more effective in black patients than in caucasians in some studies. however, noecker et al 2004 compared bimatoprost with travoprost in african-americans with glaucoma or oht, and found that bimatoprost was more likely than travoprost to achieve target pressure at 3 months. these racial differences in efficacy of these medications warrant further investigations. the investigators study aim to compare the iop-lowering efficacies of bimatoprost and travoprost in an egyptian population with primary open-angle glaucoma (oag) or ocular hypertension (oht).


Eligibility criteria:
inclusion criteria: * glaucoma and ocular hypertension exclusion criteria: * any ocular disease or medication that may raise the intraocular pressure.

Keywords: glaucoma and ocular hypertension
evaluating the efficacy of lateral heel wedges of osteoarthritis of the knee

Conditions: Knee Osteoarthritis

Summary: this study is looking at the efficacy of a sloped insole in patients with knee osteoarthritis. regularly wearing a sloped insole over the course of one year will result in a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain, decreased use of over the counter analgesics, and a clinically important improvement in the womac pain and stiffness scale.


Eligibility criteria:
inclusion criteria: * adult patients 30 years or older with medial compartment knee osteoarthritis (unilateral) and grade 4 kellgren-lawrence39 radiographic changes presenting for treatment of knee pain. * range of motion knee-flexion beyond 100 degrees and not lacking more than 15 degrees of extension. * subtalar and forefoot motion permitting foot/ankle eversion with weight bearing. * sufficient shoe toe box height to allow space for the insole and therefore comfort and compliance. * passive laxity of medial capsule and collateral ligament by knee extension test. exclusion criteria: * all other forms of knee arthritis other than oa. * knee instability- medial pseudo-opening of greater than grade 1 or detectable anterior-posterior instability. * less than grade 4 kellgren-lawrence radiographic changes in the medial compartment of the knee39. * grade 2 or greater kellgren-lawrence radiographic39 involvement of the patellofemoral or lateral compartment. * inadequate knee range of motion * balance problems requiring the use of a walker or wheel chair - ambulation with aid * diabetics with peripheral neuropathy * knee surgery within the past year * intraarticular steroid injection or visco supplementation within 6 months * stiff subtalar or forefoot joints - clinical test * inadequate shoe toe box depth to accommodate the test or control inserts * charcot joint * fixed contracture of the medial capsule and/or collateral ligament- clinical test

Keywords: knee osteoarthritis
cervical ripening balloons for same-day cervical prep

Conditions: Dilation and Evacuation

Summary: the goal of this clinical trial is to learn if a cervical ripening balloon (foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (d\&e). the main questions it aims to answer are: * is cervical preparation with cervical ripening balloon for same-day outpatient d\&e non-inferior to cervical preparation with osmotic dilators? * how feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient d\&e? * how acceptable is cervical preparation with cervical ripening balloon for same-day outpatient d\&e? participants will: * have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) * complete two surveys, one about the cervical preparation and one about the d\&e procedure


Eligibility criteria:
inclusion criteria: * individuals who desire outpatient dilation and evacuation (d\&e) * at least 18 years of age * able and willing to consent * gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound * able to read and understand english or spanish * able to obtain reliable post-procedure transportation * able to observe fasting guidelines of 6 hours prior to the d\&e procedure exclusion criteria: * medical conditions that require procedural management in the operating room * preference for d\&e procedure in the operating room
live birth rate in patients with unexplained recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss; Preimplantation Genetic Screening

Summary: study aim: to study the pregnancy outcomes and offspring development of patient with unexplained recurrent pregnancy loss treated by pgs and spontaneous pregnancy, and to compare the health economic indicators and patient satisfaction of the two modes of pregnancy, so as to better guide the clinical treatment.

400 patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy are intended to be enrolled. they are going to divided into two groups: pgs(preimplantation genetic screening) group and sp(spontaneous pregnancy) group. the pregnancy outcomes and offspring development of those patients will be followed up by our investigators.

Eligibility criteria:
inclusion criteria: * patients with two times or more unexplained pregnancy loss(less than 24 weeks of gestational age, biochemical pregnancy excluded), who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy. exclusion criteria: * anatomic abnormality of the reproductive system; endocrine metabolic disease; autoimmune related disease; chromosomal abnormalities; hydrosalpinx; cervical insufficiency.

Keywords: unexplained recurrent pregnancy loss preimplantation genetic screening spontaneous pregnancy
optimize ide for the treatment of acs

Conditions: Acute Coronary Syndrome

Summary: indication for use: "the svelte des is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-st elevation mi due to discrete de novo native coronary artery lesions. the treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm


Eligibility criteria:
inclusion criteria: * subject is an eligible candidate for percutaneous coronary intervention (pci); * subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia; * subject is an acceptable candidate for coronary artery bypass grafting (cabg); * subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria. * target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (rvd) ≥ 2.25 mm and ≤ 4.00 mm; exclusion criteria: * the subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina; * the subject's target lesion(s) is located in the left main artery; * the subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (lad) coronary artery or left circumflex (lcx) coronary artery by visual estimate; * the subject's target lesion(s) is located within a saphenous vein graft or arterial graft; * the subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;
is routine use of histopathological examination necessary after cholecystectomy ?

Conditions: Cholelithiasis

Summary: cholecystectomy has been made with benign conditions usually. the aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.

cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. routinely cholecystectomy specimens sent for histopathologic examination. the histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. the histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. also there is additional cost for the patients. because of that the idea of selective histopathologic examination has been raised.

Eligibility criteria:
inclusion criteria: * subject has cholelithiasis exclusion criteria: * subject has acute cholecystitis * subject has perforated gallbladder * subject has malignancy * subject has polyps in the gallbladder * subject has increasing wall thickness of the gallbladder * subject has malignancy in the preoperative ultrasonography in the gallbladder * subject has pregnancy

Keywords: histopathology gallbladder specimen
impact of age-related macular degeneration on daily living activitie

Conditions: Age-Related Macular Degeneration

Summary: the complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of amd. however, functional assessment of amd is most often based solely on visual acuity, and classifications of amd are based solely on structural markers. there is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (coa)

prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study, including healthy volunteers and patients with age-related macular degeneration

Eligibility criteria:
inclusion criteria: * general criteria for healthy volunteers and amd patients: * male / female participant, * age ≥ 50 at inclusion, * able and willing to provide written informed consent and comply with the study protocol, visits and assessments, * quality of ao imaging as assessed by rtx1 camera, ● deemed adequate according to the study physician, * membership of a social security scheme or beneficiary of such a scheme. * specific criteria for the amd group: * geriatric depression scale (gds) questionnaire score ≤ 10 a cogevis questionnaire score ≥ 24/30 * visual acuity greater than 4/10ths * general criteria for healthy volunteers: * no detectable visual pathologies * best monocular visual acuity (corrected to 100% of the contrast) ≥ 8/10ths before age 70 and ≥ 6/10ths after. * mmse score ≥ 20 * specific criteria for the group of healthy volunteers with central microdrusens: * no detectable visual pathologies other than the presence of central microdrusens. * best monocular visual acuity (corrected to 100% contrast) ≥ 8/10th before age 70 and ≥ 6/10th after. * mmse score ≥ 20 exclusion criteria: * pregnant, parturient or breast-feeding women, * subjects taking medication likely to cause motor, visual, vestibular or cognitive disorders (psa, neuroleptics, etc.) or who could interfere with the study examinations cannot be included in this study, * environmental opacity or eye movement disorders (nystagmus) which, in the opinion of the investigator, interfere with the quality of retinal imaging data. * any concomitant intraocular condition in the study eye (e.g. glaucoma or cataract) that, in the opinion of the investigator, would require surgical intervention during the study to prevent or treat vision loss that may result from this condition or affect the interpretation of study results, * known systemic disease which, in the opinion of the investigator, would preclude active participation in the study, * participation in any other therapeutic study evaluating a drug, * cognitively impaired subjects, illiterate subjects and subjects who do not speak the national language. * subjects with dyslexic reading disorders, * subjects subject to a reinforced protection measure or legal safeguard (curatorship, guardianship).