Kornimate/medical-research-clean huggingface dataset:
exactech humeral reconstruction prosthesis of shoulder arthroplasty pmcf (hrp)

Conditions: Osteoarthritis Shoulder; Rheumatoid Arthritis; Oncology

Summary: the objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the equinoxe humeral reconstruction prosthesis in shoulder arthroplasty over time. this study will follow subjects for a period of up to 10 years post-surgery.


Eligibility criteria:
inclusion criteria: * patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty) * patient is at least 21 years of age * patient is expected to survive at least 2 years beyond surgery * patient is willing to participate by complying with pre- and postoperative visit requirements * patient is willing and able to read and sign a study informed consent form exclusion criteria: * osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved * inadequate or malformed bone that precludes adequate support or fixation of the prosthesis * neuromuscular disorders that do not allow control of the joint * signigicant injury to the brachial plexus * non-functional deltoid muscles * patient's age, weight, or activity level would cause the surgeon to expect early failure of the system * the patient is unwilling or unable to comply with the post-operative care instructions * alcohol, drug, or other subtance abuse * any disease state that could adversely affect the function or longevity of the implant * patient is pregnant * patient is a prisoner * patient has a physical or mental condition that would invalidate the results
effects of acute hypobaric hypoxia exposure on neurocognitive performance of pre-hospital emergency service providers

Conditions: Hypobaric Hypoxia; Cognitive Deterioration; Emergency Medicine; Resuscitation; Stress Physiology

Summary: the study aims to evaluate the effects of acute hypobaric hypoxia on cognitive performance (h0: cognitive performance at 200 meters above sea level (asl) = cognitive performance at 3000 meters above sea level = cognitive performance at 5000 meters above sea level). before participating in the study, each participant will respond to a questionnaire related to high altitude exposure (prior 3 months), as well as inclusion/exclusion criteria evaluation. on day 0, after the interview and signed informed consent, the participant will undergo a medical examination that will include a general objective examination. participants will participate in a training on the emergency and safety procedures of the hypobaric hypoxia facility, as well as a refresh on cardiopulmonary resuscitation procedure. during the following two days (day 1 and 2) the study protocol will be executed (one test per day). the study protocol envisages: * a basal cognitive test battery * blind ascent in the hypobaric chamber to simulated altitude * cognitive test battery * 5 minutes of recorded chest compressions on dummies * cognitive test battery * blind descent in the hypobaric chamber. during the stay in the hypobaric hypoxic facility, each participant will be monitored in real time with the equivital© medical monitoring device. before and after the stay in the hypobaric hypoxic facility, a saliva sample will be collected, and psychological tests administered.


Eligibility criteria:
inclusion criteria: * healthy volunteers * age 18-60 yr-old * asa class i * signed informed consent exclusion criteria: * age \ 60 yr-old * asa class \> i * informed consent not signed
conjugated linoleic acid in obese women

Conditions: Lipid Metabolism Disorders; Obesity

Summary: in this trial, the investigators analyzed the effects of eight weeks of cla supplementation associated with aerobic exercise on body fat and lipid profile in obese women.

the aim of this investigation was to analyze the effects of eight weeks of cla supplementation associated with aerobic exercise on body fat and lipid profile in obese women. the investigators performed a randomized, double-blinded and placebo-controlled trial with 28 obese women who received 3.2 g/d of cla or 4 g/d of olive oil (placebo group) while performing an 8-week protocol of aerobic exercise. dietary intake (food record), body fat (dxa) and biochemical analysis (blood sample) were assessed before and after the intervention period.

Eligibility criteria:
inclusion criteria: * had no signs or symptoms of disease * no orthopedic injuries * must be inactive or moderately active (defined as performing any type of physical exercise less than twice a week) * must be non-smokers * must be free from the use of ergogenic aids * had no metabolic disorders or chronic degenerative diseases * not use drug therapy for body mass loss. exclusion criteria: * had frequency to training sessions below 85% of the total sessions
study of efficacy and safety of brodalumab in subjects with psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. the key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. the safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.


Eligibility criteria:
inclusion criteria: subjects has a diagnosis of psoriatic arthritis (by the classification of psoriatic arthritis criteria (caspar), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). subjects must have at least 1 psoriatic skin lesion. exclusion criteria: • -subject has known history of active tuberculosis. * subject has a planned surgical intervention between baseline and the week 52 evaluation. * subject has an active infection or history of infections. * subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled. * subject has any concurrent medical condition or electrocardiogram (ecg) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject. subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs) • subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety

Keywords: psoriatic arthritis brodalumab amg 827
evaluation of the diagnostic contribution of high-throughput exome sequencing for patients with convulsive encephalopathy of unknown etiology: pilot study to improve genetic counselling

Conditions: Epileptic Encephalopathy of Unindentified Genetic Origin

Summary: congenital epileptic encephalopathies (ee) are predominantly genetic in origin. their diagnosis is hampered by the large number of genes involved and their low recurrence. genetic study in routine diagnosis is limited by the existing techniques and the development costs. the routine diagnostic implementation of high throughput sequencing pushes these limits. high throughput exome sequencing (es) showed superior diagnostic performance in all diagnostic settings studied. this pilot study is dedicated to evaluating the diagnostic performance of high throughput es in ee, with an implementation and analysis strategy allowing for a direct transfer to routine diagnostics. this novel approach should improve the diagnostic rate while reducing the diagnostic cost per patient.


Eligibility criteria:
inclusion criteria: * diagnosis of epileptic encephalopathy, defined by the clinical association of epilepsy and a significant delay in acquisition * family case with recurrence in siblings, suggesting autosomal recessive transmission or x-linked inheritance (with or without parental consanguinity), or sporadic case resulting from inbreeding. * lack of etiologic orientation based on clinical examination. * normal routine diagnostic genetic examinations including a metabolic check-up, array cgh analysis. * brain imaging which does not suggest an acquired cause. exclusion criteria: * unavailable parental samples * diagnostic orientation from one of the tests mentioned above * brain imaging suggesting anoxia sequelae
a prospective, randomized, comparative study to assess the prevention of surgical site infection (ssi's) in revision total joint arthroplasty patients treated with single-use negative pressure wound therapy (pico) or standard care dressings (aquacel ag surgical dressing).

Conditions: Surgical Incision

Summary: the primary aim of this study is to determine if the ssi rate following revision total hip and knee arthroplasty is reduced in patients treated with the pico device compared to patients with traditional postoperative dressings. our secondary goals include; comparing the amount of wound drainage, rate of resolution of wound drainage, length of hospital stay, functional outcomes, and economic implications of wound drainage and ssi after revision arthroplasty comparing pico and traditional dressings.


Eligibility criteria:
inclusion criteria: 1. patient ≥18 years old 2. male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females 3. subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty 4. subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the investigator, sub-investigator or other designated study staff member has explained the study procedures, risks, and contact information 5. subjects deemed able to understand and comply with study visit schedule and procedures exclusion criteria: 1. wounds that require daily inspection 2. active bleeding within the surgical site 3. pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception 4. subjects on warfarin therapy. resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic inr levels 5. skin integrity issues that preclude the use of negative pressure wound therapy (npwt) 6. subjects undergoing primary total joint procedures 7. subjects with a known history of poor compliance with medical treatment 8. subjects who have participated in this trial previously and who were withdrawn 9 . subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
weight in lower limbs improves gait ataxia of in machado-joseph disease patients

Conditions: Machado-Joseph Disease

Summary: few studies evaluated the efficacy of adding weights on the lower limbs in patients with ataxic disorders. there is no current evidence on which would be the most appropriate weight for use in this context. to assess progress and benefits of using this load, gait of symptomatic carriers of spinocerebellar ataxia type 3/machado joseph disease the objective of the study is to evaluate the gait with and without different load weights on lower limbs. outcomes were the scale for the assessment and ataxia rating of (sara), kinematic gait assessment by the accelerometer and gyroscope and the patient global impression (pgi) about which weight they prefer for walking.


Eligibility criteria:
inclusion criteria: * patients should have between 18 and 65 years of age and independent gait exclusion criteria: * were the need of assistive devices for walking ≤ 10m (such as crutches, wheelchairs and orthotics) * item gait of scale for the assessment and rating of ataxia (sara)19≥, presence of other neurological disease that affect motor system * orthopedic impairments of lower limbs (fractures or surgeries in the past 6 months) * difference between the lower limbs greater than 3.0 cm

Keywords: sca 3 ataxic gait
intensive therapies in children with hemiplegia

Conditions: Infantile Hemiplegia

Summary: this is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.

the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.

Eligibility criteria:
inclusion criteria: * children diagnosed with unilateral infantile cerebral palsy, congenital infantile hemiparesis. * ages between 5 to 10 years. * levels of i-iii within the , manual ability classification system, macs. * levels of i-iii within the gross motor function classification system, gmfcs exclusion criteria: - diseases not associated with infantile hemiparesis. * low cognitive level to understand the execution of activities. * surgeries of the upper extremity during the 6 months prior to the intervention. * structured contractures in the affected upper extremity that cause functional impotence. * botulinum toxin two months prior to the intervention and application of it during the treatment. * epilepsy not controlled pharmacologically

Keywords: infantile hemiplegia upper extremity physical therapy
music breathing therapy for children with attention-deficit hyperactivity disorder and their caregivers

Conditions: Resilience

Summary: this pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress.

attention-deficit hyperactivity disorder (adhd) is a prevalent neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impact various aspects of both the child's and the caregiver's functioning. evidence shows that cultivating resilience helps children with adhd manage emotional dysregulation and improve caregivers' psychological well-being. music breathing therapy - an adaptation of the bonny method of guided imagery and music (gim) - has shown beneficial effects in enhancing resilience and alleviating psychological distress among different populations. however, it remains unclear whether it is a feasible and effective intervention to enhance the resilience of chinese school-aged children with adhd and their caregivers. aims: * to determine the feasibility (in terms of rates of recruitment, retention, and attendance), and acceptability of the intervention * to examine the effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress. hypotheses: it is hypothesized that compared with dyads in the control group, those who receive the dyadic video-assisted gamified music breathing therapy will report the following outcomes: higher levels of dyads' resilience, reduced children's emotional and behavioral symptoms, lower levels of parents' parenting stress and psychological distress at immediately post-intervention (i.e., the 6-week follow-up).

Eligibility criteria:
inclusion criteria: children * have a clinically documented diagnosis/suspected adhd diagnosis according to dsm-5 criteria * aged 7 to 12 years (school age) * can read and communicate in chinese parents * aged 21 years or above * are the primary caregivers and living together with the child * can read and communicate in chinese exclusion criteria: children * have other disabling diseases (physical disability, mental disability, autism) that might limit their full participation in the study. * have been engaged in any music intervention in the past 6 months parents * are caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness * has a diagnosed mental illness, cognitive impairment, or learning problem, and/or is taking regular psychotropic medications that might limit their full participation in the study * have been engaged in any music intervention in the past 6 months
study of vintafolide (mk-8109, ec145) for the treatment of recurrent or refractory solid tumors (mk-8109-006, ec-fv-01)

Conditions: Cancer

Summary: this is a phase i clinical trial evaluating the safety and tolerability of escalating doses of vintafolide (ec145) in participants with relapsed or refractory advanced tumors. the primary objective of this study is to determine the safety and maximum tolerated dose of vintafolide given by intravenous bolus or infusion. the efficacy of the treatment will also be measured.

this is a dose escalation study of vintafolide administered by intravenous (iv) bolus or infusion during weeks 1 and 3 of a 4-week cycle to participants with solid tumors refractory to current therapies. vintafolide is a drug that is specifically designed to enter cells via a folate vitamin receptor. experimental evidence shows that the target receptor is over-expressed in many human cancers. there are no previous human studies of vintafolide treatment; however, lab research (research in test tubes and/or animals) using vintafolide has shown activity against tumors in animals. this activity in animal models suggests that vintafolide may be useful as chemotherapy against human cancers.

Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of neoplasm * no effective standard therapeutic options * eastern cooperative oncology group (ecog) performance status of 0-2 * \>=4 weeks post therapeutic radiation of chemotherapy \>=6 weeks for nitrosoureas and mitomycin c) and recovery from associated toxicities * negative serum pregnancy test for women of child-bearing potential and willingness to practice contraceptive methods * adequate bone marrow reserve, renal, and hepatic function exclusion criteria: * concurrent hematological malignancies * women who are pregnant or lactating * evidence of symptomatic brain metastases * receiving concomitant anticancer therapy (excluding supportive care) * requires palliative radiotherapy at time of study entry

Keywords: cancer phase i ec145 recurrent refractory solid tumors experimental
predictive biomarkers in stage ii/iii gastric cancer for adjuvant chemotherapy

Conditions: Gastric Cancer

Summary: adjuvant chemotherapy followed by curative gastrectomy for stage ii/iii gastric cancer has improved disease free time and survival. however, there are still considerable number of patients experience relapse even after adjuvant chemotherapy. in an attempt to select patients who really benefit the postoperative adjuvant chemotherapy, we have identified potential biomarkers (nf-kappab/jnk) from cell line panel screening followed by immunohistochemical validation. in the present study, we further validate the significance of the biomarkers in a larger set of clinical samples to see if chemotherapeutic response can be determined immediately after surgery.


Eligibility criteria:
inclusion criteria: * pathologically confirmed gastric cancer. * operated before november 2009. * stage ib/ii(except for t1, t3n0)/iii. * received postoperative (r0) adjuvant chemotherapy (s-1). * not received postoperative (r0) adjuvant chemotherapy (surgery alone). * signed informed consent to provide paraffin embedded tissue of removed specimens. exclusion criteria: * with advanced neoplastic lesions other than gastric cancer. * paraffin embedded tissue is not available. * unknown s-1 treatment condition.

Keywords: gastric caner, adjuvant chemotherapy
task oriented training and evaluation at home (tote home)

Conditions: Stroke

Summary: objective: to determine the effectiveness of an upper extremity, task oriented training program delivered at home (tote home) for people who are in the subacute recovery phase of a stroke. method: a single-subject ab series design with a follow-up to assess the effectiveness of tote home which includes a maximum of 30, one hour sessions of training conducted in participants' homes. repeated target measures of accelerometry and level of confidence to be analyzed throughout the study. change scores from standardized assessments to be evaluated at baseline, post-intervention, and follow-up time periods.

hemiparesis following a stroke frequently leads to "learned non-use" of the weaker arm and hand. task oriented training has been suggested as a contemporary neurorehabilitation technique. a single-subject ab series design with a follow-up was conducted to assess the effectiveness of a task oriented training program administered in participants' homes. this intervention, task oriented training at home (tote home), incorporated current experience-dependent plasticity aspects modeled after the acquired skill acquisition program (asap) protocol parameters and principles of task oriented training as suggested by lang and birkenmeier in 2014. repeated measures of accelerometry and level of confidence on a priority task were analyzed with visual analysis of changes in level, trend, and slope. change scores from standardized assessments for the upper extremity, motor activity log, stroke impact scale question of recovery, functional test for the hemiparetic upper extremity, and canadian occupational performance measure were evaluated on data collected at baseline, post-intervention, and follow-up time periods.

Eligibility criteria:
inclusion criteria: * upper extremity hemiparesis due to a stroke but met minimal movement criteria in the affected arm and hand (at least 10 degrees of active movement at the wrist, elbow, and shoulder movement, along with 10 degrees of active movement in the thumb and two other fingers) * minimal cognitive deficits as demonstrated by a 24 or higher on the mini-mental status exam * able to identify at least five specific tasks participants wish to achieve with their affected upper extremity. this was assessed with the canadian occupational performance measure (copm) * at least 21 years of age * able to communicate in english * 3-12 months after their stroke which would classify them in the subacute level of recovery * all formal occupational therapy was completed. exclusion criteria: * upper extremity pain that interfered with activities of daily living * requiring maximal assistance for mobility * arm or hand injury (unrelated to the stroke) * upper extremity amputations * inability to participate due to any illness, social or geographical reason, and any other diagnosis or limiting conditions that would affect participation