Kornimate/medical-research-clean huggingface dataset:
robotic knee orthosis-assisted walking in cp

Conditions: Crouch Gait; Cerebral Palsy (CP)

Summary: robotic exoskeletons are becoming increasingly accepted to provide upright mobility in individuals with neurological disorders. these devices can assist in overcoming gravitational forces and reduce energy consumption. agilik is one such device intended for children with neurological disorders. however, agilik is relatively new, and its efficacy in children with cp is unknown. therefore, this study aims to assess the effectiveness of agilik as an assistive device for children with cp and crouch gait. in this pilot study, ten children with cp, gmfcs level ii, and crouch gait will walk with agilik under the supervision of a physical therapist. assessments of walking with afo and agilik will evaluate the efficacy of the device. the pilot study will assess if agilik decreases crouch and improves gait characteristics in children with cp.

robotic knee orthosis (rko) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the efficacy of this technology in children with cp is unknown. this study aims to assess the effectiveness of agilik as an assistive device for children with cp. ten children with cp, ages 8 to 17 years, and at gmfcs level ii, will be recruited for this pilot study. each child will participate in a total of four visits over four weeks duration. the first three visits will also include rko device fitting and tuning, followed by rko-assisted walking practice to help with device acclamation. the walking practice will last up to 30 minutes. a two-minute walk test (2mwt) will be conducted at the first visit, which will serve as a reference to assess any shift in endurance from device-tuning/practice visits. the fourth and final visit will include 2mwt and 3d motion capture of shod and rko-assisted conditions and may take up to 3 to 4 hours.

Eligibility criteria:
inclusion criteria: * diagnosed with cerebral palsy at gmfcs level ii * exhibits crouch gait * between 8 to 17 years of age * hip flexion contracture less than 5 degrees * knee flexion contracture less than 20 degrees when measured in prone with hips extended * thigh-foot angle is between 10 degrees (internal) to 25 degrees (external) in prone * can walk a minimum distance of 10 meters without stopping exclusion criteria: * plantarflexion contracture, when measured in neutral foot alignment * no other neurological, musculoskeletal, or cardiorespiratory health conditions or injuries * the presence of any cognitive impairment that could limit the ability to understand, follow simple directions, and inform when in pain * inability to participate in the study because of recent orthopedic surgery (within twelve months) or botox intervention (within six months)

Keywords: robotic knee orthosis crouch gait flexed-knee gait cerebral palsy
effect of zinc and probiotics supplementation on laryngeal cancer patients undergoing laryngectomy surgery to improve prognosis and better wound healing

Conditions: Laryngectomy

Summary: using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.

zinc supplementation decrease plasma levels of oxidative stress markers, inflammatory cytokines and il6. low serum zinc level was believed to influence the survival of laryngeal cancer patients and hence,using zinc supplementation would improve survival.zinc help in increasing wound healing as involve in membrane repair, decreasing oxidative stress , coagulation , suppressing inflammation and modulating .probiotics stimulates epithelial cells to release interleukin 6 (il-6) and stimulates dendritic cells and macrophages that help in releasing tnf-α and ifn-γ , development iga b lymphocytes that cause increase production of igm, igg and ige antibodies.using probiotics preoperative or post-operative offer good chance for decreasing morbidity , infection rates , abuse of antibiotics and complications. zinc and probiotic suppose to provide better wound healing low incidence of infections and fistula after total and partial laryngectomy

Eligibility criteria:
inclusion criteria: * all patients presenting to ent department will be subjected eligible adults patients newly diagnosed at outpatient clinic with laryngeal cancer at any stage and will undergo total/partial laryngectomy surgery. patients with level of hemoglobin \&gt;9 mg/dl and serum albumin 3g/dl according to (crosetti et al. 2021). staging of laryngeal cancer according to the american joint committee on cancer (ajcc) 8th edition by tnm system. exclusion criteria: - 1. impaired renal function sr.cr≤2.5 (zinc clearance). 2.previous history of cancer diseases in other sites( previous chemotherapy or radiation). 3.hypersensitivity to probiotics and zinc.

Keywords: laryngeal cancer , zinc , probiotics, total laryngectomy
randomized study evaluating ixabepilone plus capecitabine or docetaxel plus capecitabine in metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. the safety of this combination therapy will also be evaluated.


Eligibility criteria:
inclusion criteria: * participants with metastatic breast cancer * measurable disease * up to 1 chemotherapy regimen is acceptable. participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. there is no timeframe for prior paclitaxel in the metastatic setting. * human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib * eastern cooperative oncology group performance status of 0-1 * age younger than 18 years * women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products exclusion criteria: * more than 1 chemotherapy regimen for the treatment of metastatic breast cancer * prior treatment with any epothilone, capecitabine, or docetaxel * prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). if prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. there must be at least 1 week between focal/palliative radiation and administration of study medication. * any current or previous history of brain and/or leptomeningeal metastases * neuropathy greater than grade 2 * any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix * uncontrolled diabetes mellitus * chronic hepatitis * hiv-positive status * administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. hormonal anticancer agents must be discontinued at least 14 days prior to study medication. hormonal replacement therapy is acceptable * biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry
synovial aspiration and serological testing in two-stage revision arthroplasty of prosthetic joint infection

Conditions: Diagnosis Prosthetic Joint Infection

Summary: the two-stage protocol is gold standard in terms of infection control treating prosthetic joint infections of total hip and total knee arthroplasty. the antibiotic pause for diagnostic reasons before reconstruction (stage two) is discussed concerning persistence of infection and development of resistant bacterial strains. serological markers and synovial analysis are common use to exclude persistence of infection. the investigators therefore asked 1) is the serological testing of c-reactive protein and leukocytes a valuable tool to predict a persistence of infection and 2) what is the role of synovial aspiration of pmma spacers on hip and knee joints.


Eligibility criteria:
inclusion criteria: * patients with periprostheitc joint infection exclusion criteria: * reinfection in history
denosumab for the treatment of fibrous dysplasia/mccune-albright syndrome in adults (defid)

Conditions: Fibrous Dysplasia; McCune Albright Syndrome

Summary: fibrous dysplasia/mccune-albright syndrome (fd/mas) is a rare disease, consisting of the replacement of normal bone tissue with fibrous tissue. fd lesions may be isolated in one or more bones or may be associated with endocrinopathies in mccune-albright syndrome. bone lesions constitute of weak bone tissue, leading to higher risk of fractures, pain and decreased quality of life. there is no cure for fd lesions and current therapies failed to soothe patients' complaints or to display any effect on progression of the lesions on imaging. however, the rankl-inhibitor denosumab demonstrated encouraging results in mouse models and in off-label clinical use, leading to clinical, biochemical and radiographical improvements. study's aim is to investigate whether 3-monthly denosumab will improve the clinical, radiological and biochemical manifestations of fd bone lesions.

eligible patients will be randomized to treatment with either subcutaneous dmab 120mg or placebo at baseline and 3 months in a blinded fashion. at 6 months, after 2 injections, patients with pain score \<4 will exit the study to discontinue study medication and proceed in usual care, while patients with pain score ≥4 or lesional growth will be offered dmab 120 mg at 6 and 9 months in an open-label design.

Eligibility criteria:
inclusion criteria: * symptomatic patients with established diagnosis of fd/mas and closed growth plates(\>18 years) * pain in the region of an fd localization, not responding to adequate pain treatment and without mechanical component e.g. impending fracture * pain score from fd lesion for maximum or average pain on vas ≥ 4 * increased lesional activity defined as increased bone turnover markers (alp, p1np or ctx) or increased activity on na\[18f\]-pet/ct or bone scintigraphy in at least one lesion * normal levels of calcium, parathyroid hormone and vitamin d (supplementation is allowed) * treated hypophosphatemia (defined as \>0.7 at two separate measures) * good dental health (last check within the last 12 months) exclusion criteria: * active pregnancy wish, pregnancy or nursing * pain not related to fd * uncontrolled endocrine disease * untreated vitamin d deficiency, hypocalcemia or hypophosphatemia * previous use of bisphosphonates or dmab \< 6 months before inclusion ('6 months wash out') * previously reported severe side effects on dmab * inability to fulfil study requirements * poor untreated dental health without intention to get treatment * treatment with other bone influencing drugs, such as high doses corticosteroids
centers for education on research and therapeutics - heart failure: targeted intervention study

Conditions: Heart Failure

Summary: the objective of this study is to evaluate whether a quarterly feedback, education and performance improvement site-based intervention has a greater impact on quality performance and adherence to evidenced-based guidelines than existing on-demand feedback. this study will use a randomized design to compare changes in quality performance and adherence to selected measures among hospitals using existing on-demand reports and general quality improvement (qi) efforts versus those receiving intensive, targeted qi feedback via reports, teleconferences, webinars, and specialized tool kits.


Eligibility criteria:
inclusion criteria: * all sites participating in get with the guidelines heart failure. exclusion criteria: * sites in get with the guidelines heart failure which opt out of participation.

Keywords: quality improvement
mirror-box training in adults with chronic hemiparesis secondary to stroke

Conditions: Stroke

Summary: the purpose of this project is to assess the effects of four weeks of mirror-box training on weakness of one arm secondary to stroke. primary measures are function and strength. secondary measures will evaluate muscle tone, flexibility, and the subject's perception of their everyday function and improvement. research hypothesis: for chronic upper limb hemiparesis secondary to stroke, four weeks of mirror-box training with movement of the unaffected limb only results in a mean increase of 10 points on the fugl-meyer test of motor recovery (upper extremity).

due to the relatively new nature of mirror training, there are few randomized controlled studies. this pilot case series will serve as our initial step in trying to identify the frequency, duration, and treatment exercises needed in this population. additionally, this pilot will allow us to ensure our outcome measures are appropriate to detect meaningful treatment changes. after obtaining informed consent, patients will undergo two separate baseline assessments of strength, function, and tone 4 weeks apart. training sessions will consist of supervised activities using the unaffected arm while observing its mirror reflection; the affected arm will remain still. sessions will be one hour a day, five days a week, for four weeks. patients will be tested for strength, function and tone in the affected arm at completion of the four week treatment period by the same occupational therapist that performed the pretests.

Eligibility criteria:
inclusion criteria: * first unilateral ischemic stroke resulting in hemiparesis at least 6 months prior to enrollment. * age at time of enrollment: 30-80 years. * voluntary informed consent of patient. * patient willing to comply with protocol and is available for all scheduled visits. * residual upper extremity hemiparesis. * no changes in medications planned during 8-week participation. * no other motor rehabilitative therapy during 8-week participation, including e-stim and acupuncture. * at least 20 degrees of active wrist extension and 10 degrees of active finger extension against gravity in the affected upper limb, as measured by goniometry. exclusion criteria: * serious cognitive deficits, as evidenced by score of \<20 on modified mini-mental status exam * hemorrhagic or bilateral strokes * excessive spasticity at the elbow, wrist, or hand, defined as a modified ashworth scale score of \>2 * history of botulinum toxin injection in affected upper extremity in the past 4 months * lacking \>40 degrees of passive elbow extension * less than 45 degrees of passive shoulder flexion * global or receptive aphasia present on physical exam * hemispatial neglect present on physical exam * patient participating in constraint-induced therapy during study time period * severe visual deficits or visual field deficits as determined by ability to ascertain number of fingers held up on visual field testing * deformity/amputation of unaffected upper limb

Keywords: mirror training stroke hemiparesis rehabilitation
fluoropyrimidine tailored-dose based on uracil concentration in patients treated for digestive carcinomas: evaluation of clinical practice

Conditions: Digestive Carcinoma

Summary: digestive carcinomas chemotherapies regimen are mostly based on fluoropyrimidine drugs (5-fluorouracil (5-fu) or capecitabine). 5-fu is mainly catabolised by dihydropyrimidine dehydrogenase (dpd) and partial or complete dpd deficiency can cause severe adverse reactions. different strategies have been proposed to predict dpd deficiency; the two main approaches are phenotyping the enzyme activity (directly or indirectly), or genotyping the four main polymorphisms associated with 5-fu-toxicity. in february 2018, the french medicines agency (agence nationale de sécurité du médicament et des produits de santé, ansm) recommended dpd genotyping for all patients receiving fluoropyrimidine-based treatment to improve its safety as compared to the european medicines agency (ema)13 and others pharmacogenetics working group. in december 2018, a new guideline from the french cancer institute (institut national du cancer, inca) and the french health authority (haute autorité de santé, has) recommended the measurement of the uracil blood level before genotyping dpd and dose adaptation if this level is greater than 16 ng/ml. the aim herein is to assess how this recommendation has been implemented in clinical routine. 5-fu displays a dose-response relationship regarding both its efficacy and its toxicity, did tailored-dose impair the treatment efficacy as it decreased the risk of toxicity? to address that matter we conducted a retrospective study to evaluate how fluoropyrimidine dosage is adapted to uracil concentration with an emphasis on how patients outcome were affected. we compared time to failure and overall survival between patients with an uracil concentration \ or = 16 ng/ml.


Eligibility criteria:
inclusion criteria: * digestive cancer * an uracil dosage performed between february 2018 to january 2020 * received at least one cycle of fluoropyrimidine-based chemotherapy in one of the three oncology departments (hopital edouard heriot \[lyon\], centre hospitalier de lyon sud \[lyon\], hopital de la croix rousse \[lyon\]). exclusion criteria: * age limit less than 18 years * not treated with fluoropyrimidine based chemotherapy * missing data for uracil concentration or chemotherapy dosage

Keywords: uracil dpyd toxicity clinical practice overall survival
virtual reality in lower limb adult burn

Conditions: Burns

Summary: to investigate the potential effects of wii fit rehabilitation programs on functional capacity, mobility, balance and muscle strength in lower limb burn patients after hospital discharge.

the use of virtual reality technology in burn conditions improved joint flexibility and reduced pain associated with physical therapy, dressing changes, and wound debridement. however, the primary concern of burn rehabilitation is not only survival but also maximizing functional outcome and decreasing the time for return to work.

Eligibility criteria:
inclusion criteria: * adult with a deep partial thickness or a full thickness burn in the lower extremities. * induced by either a scaled or a flame thermal burn. * total body surface area (tbsa) more than 40%. * age ranged from 18 to 40 years. * recent hospital discharge. exclusion criteria: * infection. * diabetes. * inhalation injury. * fracture. * degenerative joint diseases of the lower extremities. * peripheral nerve diseases. * pre-established psychologically and physically disorders.

Keywords: burns lower limb burns virtual reality
study of roxadustat in the treatment of acute myocardial infarction

Conditions: ST Elevation Myocardial Infarction

Summary: depite successful primary percutaneous coronary intervention (pci) and standardized medical treatment, prognosis of acute st-elevation myocardial infarction patents are still a poor, with high morality and various complications such as heart failure. roxadustat is a new drug targeting hypoxia-inducible factor prolyl hydroxylase (hif-ph) inhibition and has shown promising effect in reducing infarct size in pre-clinical studies. this study aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute st-elevation myocardial infarction.

this study is an open-label, paralleled, randomized controlled trial. it aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute st-elevation myocardial infarction.

Eligibility criteria:
inclusion criteria: * acute stemi (st segment elevation myocardial infarction) diagnosed by st elevation * coronary angiography within 12 hours of symptom onset, with timi flow grade 0 - 1 of culprit vessel * primary pci with timi flow grade 2 - 3 after successful intervention * capable and willing to provide informed consent and capable of completing study visits exclusion criteria: * previous acute myocardial infarction history * cardiogenic shock at admission * previously treated by roxadustat * contraindications of roxadustat treatment * contraindication of cardiac mri (e.g. egfr \< 30 ml/min, pacemaker, metal prosthesis, etc.)

Keywords: st elevation myocardial infarction roxadustat infarct size cardiac mri
crt shuntcheck "fit & function" study

Conditions: Hydrocephalus

Summary: an exploratory "fit \& function" study of continuous real time (crt) shuntcheck, a non-invasive method for monitoring changes in cerebrospinal fluid (csf) shunt flow in hydrocephalus patients. the device will be tested on 10 pediatric patients (at johns hopkins hospital) and 10 adult patients (at lifebridge health) and results will be used to optimize device design.

an exploratory "fit \& function" study of continuous real time (crt) shuntcheck, a non-invasive method for monitoring changes in csf shunt flow in hydrocephalus patients. this study will gather information to refine the design of the crt shuntcheck sensor. our aim i product work will yield a clinic-ready prototype which adheres well to human skin, conforms to the curve surface of the clavicle and provides a safe level of skin cooling over an extended period of time. many of the clinical uses of crt will involve patient movement - standing up to investigate suspected overdrainage, or the simple fidgeting of children undergoing monitoring. the aim ii fit and function testing will most importantly identify movement-related product performance issues. if we can identify the causes of "signal noise", we can modify our sensor design to make it less susceptible to "motion artifacts". additionally testing will identify age/size specific issues - is the sensor small enough for use on younger children, does the looser skin of older adults generate move motion artifacts in the signal. these studies will include 10 pediatric and 10 adult asymptomatic patients who are willing to undergo crt shuntcheck testing over a one hour period. test results will not be used to guide patient care and testing will not interfere with or delay any other patient testing or care.

Eligibility criteria:
inclusion criteria: 1. for the pediatric subjects, males or females, older than three and less than 20 years of age. 2. for the adult subjects, males or females, older than 35 years of age 3. parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. if the subjects are incapable of giving assent, then only parent/guardian consent is required. 4. possess an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle. exclusion criteria: 1. inability or unwillingness of the parent/guardian or alert subject to give informed consent/assent (when appropriate) as required by the institutional review board. 2. study testing would interfere with emergent subject care or if the subject is scheduled to go the or in short order. 3. presence of an interfering open wound or edema over the shunt.

Keywords: hydrocephalus csf shunt