Kornimate/medical-research-clean huggingface dataset:
early mobilization of operatively stabilized distal radius fractures - a randomized controlled trail

Conditions: Closed Fracture of Lower End of Radius and Ulna

Summary: the purpose of this study is to evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast

all patients with a distal radius fracture treated by surgery (palmar angle stable plate) will be included in this study and randomised into two groups according the consort guidelines of prospective randomised trails. one group ("early mobilisation") receive a removable plastic cast for one week and are allowed to move the wrist directly postoperative. the other group ("control group") received a non removable cast for 5 weeks. both groups underwent physiotherapy two times a week. the control group was only allowed to move the closed-by joints. in the 6., 9., 12. postoperative week, a half and one year after the operation the patients underwent range of motion (rom), grip strength measurement and pain according to the visual analogue scale (vas). hand function will be analysed according the prwe (patient-rated wrist evaluation) score, dash (disabilities of the arm, shoulder and hand) score and mayo wrist score. * inclusion criteria: * age ≥ 18 and ≤ 75 years * a2 - c3 distal radius fracture * no acute or older injury that influences hand function * operative stabilized by palmar angle stable plate * exclusion criteria: * age ≥ 76 years * age \< 18 years * c3.3 radius fracture * acute or preexisting injures that influences hand function * pregnancy * neurologic disorders * incapacitated people

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 75 years * a2 - c3 distal radius fracture * no acute or older injury that influences hand function * operative stabilized by palmar angle stable plate exclusion criteria: * age ≥ 76 years * age \< 18 years * c3.3 radius fracture * acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people

Keywords: distal radius fractures early mobilization postoperative treatment outcome
expectation and response to levodopa and acupuncture in parkinson's disease

Conditions: Parkinson's Disease

Summary: to investigate how levodopa and acupuncture affect fatigue and muscle function in people who suffer from parkinson's disease. subjects may choose to participate in levodopa or acupuncture part, or both. study procedures include an exercise protocol, transcranial magnetic stimulation (a non-invasive type of brain stimulation that cause small muscle twitch), a blood draw, and personality surveys.

subjects will answer surveys, have their blood drawn, undergo tms and perform an exercise. the tms/exercise task will measure fatigue and muscle response. the surveys will describe personality and measure fatigue. the ctrc will do genotype studies on the blood to look for genetic differences. each subject is eligible to receive both study treatment types (levodopa and acupuncture). depending upon the study treatment type they choose, each subject will be randomly assigned to one of six possible subject groups: ia. full expectancy; levodopa: subjects will be told that they are taking levodopa. ib. half expectancy; levodopa: subjects will be told that they have 50% chance of receiving levodopa or placebo. ic. no expectancy; levodopa: subjects will be told that they are receiving placebo levodopa. iia. full expectancy; acupuncture: subjects will be told that they are receiving real acupuncture. iib. half expectancy; acupuncture: subjects will be told that they have 50% chance of receiving real or sham-acupuncture. iic. no expectancy; acupuncture: subjects will be told that they are receiving sham-acupuncture. subjects will attend four visits for the levodopa part and/or three visits in the acupuncture part. on the first visit, subjects will answer questionnaires and have samples of their blood collected. on the other visits, subjects will undergo tms while they perform a repetitive exercise task. subjects will then either wait for 30 minutes or receive the investigative intervention that they have been randomly assigned for that particular visit, and then repeat the tms/exercise task.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of parkinson's disease * able to withdraw parkinson's disease medication for 12 hours prior to a study visit * must be currently using levodopa to qualify for the levodopa part of the study exclusion criteria: * history of seizures * presence of any metal in the body, including dbs stimulators, pacemakers, metal plates or pins * severe cognitive deficits or psychosis * evidence of any clinically unstable disease, such as cancer, hiv/aids; unstable heart condition or other conditions that might require hospitalization * evidence of another neurological disease, such as multiple sclerosis, amyotrophic lateral sclerosis, or huntington's disease

Keywords: fatigue; tms; mep
the i-kan study: internet insulin education for kansans

Conditions: Type 2 Diabetes

Summary: the primary purpose of the study is demonstration that teaching insulin management in small groups of type 2 diabetes patients in 4 weekly "live" internet sessions is safe and provides an important resource for rural diabetes care providers who may otherwise, because of lack of time or staff, not be able to put patients on insulin who need it.

the proposed project will test in a limited number of rural and semi-rural sites in the state of kansas an innovative model of synchronous ("live") internet initiation and intensification of once daily basal insulin glargine or detemir in type 2 diabetic patients that can be deployed statewide in a subsequent larger study (r18). the study's specific aims are to 1) develop a synchronous ("live") interactive internet-administered course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve a hba1c \< 7.0% using a treat-to-target algorithm; and 2) to assess for the internet patients selected clinical and psychometric outcomes. these will include hba1c, frequency and severity of hypoglycemia, psychological resistance to insulin treatment, diabetes quality of life, and treatment satisfaction. the study builds upon the findings of the treat-to-target and initiate trials, as well as on successful internet interventions for weight management, and both lays the conceptual foundation and gathers the expertise to successfully apply for the r18, which will have as primary aims addressing of delays to insulin therapy documented in the dawn study and cost effectiveness analysis of the internet intervention. the study hopes to show that internet teaching of basal insulin therapy is comparable to traditional insulin management with respect to safety and effectiveness as measured against expected (published) results for frequency of hypoglycemia and percent of patients reaching target. psychometric outcomes are exploratory - and hypothesis generating with respect to the subsequent r18 application.

Eligibility criteria:
inclusion criteria: * t2dm, meets provider criteria for insulin initiation; starting or having started insulin treatment no longer than six months prior to enrollment or has not yet committed to starting insulin but has agreed to participate in the education * broadband internet and experience with logging into a password-protected site (e.g., ecommerce or social networking); * ability to purchase or otherwise acquire glargine/detemir insulin and testing supplies. exclusion criteria: * use of oral glucocorticoids or second generation anti-psychotics; * previous use of self-administered insulin more than six months prior to enrollment; * gestational diabetes or other endocrine conditions causing hyperglycemia; treatment for a malignant condition other than basal cell carcinoma in situ within prior two years; * renal insufficiency (ast/alt \>2 or concurrent liver disease except nash); * pregnant or planning to become pregnant within 6 months; * hba1c \ 250 mg/dl.
activated protein c and microcirculation

Conditions: Severe Sepsis; Septic Shock

Summary: objective: to test the hypothesis that recombinant activated protein c (apc) therapy improves the microcirculation of severe septic patients. design: prospective, open study. setting: university 12-beds intensive care unit. patients: septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis were included in a one year period. interventions: patients who had no contraindication to apc administration received apc at a dose of 24 mcg/kg/h for 96 hours. patients with contraindications to apc infusion were considered as controls.


Eligibility criteria:
inclusion criteria: * septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis exclusion criteria: * hematologic or advanced malignancies * liver cirrhosis * severely impaired consciousness (glasgow coma scale score \<7 of 15) * therapeutic limitations (do-not-resuscitate orders)
the efficacy of simulation manikins in the military medics training

Conditions: War-Related Injuries

Summary: the aim of the study is to verify the applicability of simulation manikin in combat training of military medics. the research will be conducted on healthy volunteers - medics of the czech armed forces, as a part of the compulsory medical courses required for foreign military missions as a "combat life saver". comparison of the performance of two groups of course participants who were trained using the standard approach versus experiential learning using simulation manikins.

with the development of modern hi-tech manikins and their growing popularity in the training of "civilian" medics, the possibilities of their application in the training of military medics are emerging. the aim of the study is to verify the applicability of simulation manikin in combat training of military medics. the research will be conducted on healthy volunteers - medics of the czech armed forces, as a part of the compulsory medical courses required for foreign military missions as a "combat life saver". comparison of the performance of two groups of course participants who were trained using the standard approach versus experiential learning using simulation manikins. in addition to monitoring the particular professional performance of the trainees, changes in basic physiological functions, including the endocrinological response to stress conditions, will be evaluated.

Eligibility criteria:
inclusion criteria: * active soldier during the tactical combat casualty care course exclusion criteria: * not willing to participate

Keywords: combat life saver simulation medicine stress response
study to assess the safety and efficacy of selk2 to prevent blood clots in patients undergoing total knee replacement

Conditions: Venous Thromboembolism

Summary: the main purpose of this study is to determine if an investigational medication called selk2 works in preventing a condition called "venous thromboembolism" (vte) in patients having a total knee replacement. selk2 has been designed to attach to a protein found on blood cells and blood vessels. by attaching to this protein, selk2 is designed to decrease the inflammatory process in the blood vessel wall that leads to the formation of blood clots in the vessel (called thrombosis). by decreasing the inflammatory process, selk2 may reduce the risk of vte following joint replacement surgery. in addition, because selk2 is not a blood thinner, it is expected that the risk for bleeding will also be reduced.


Eligibility criteria:
key inclusion criteria: * males or females, 18-80 years of age (inclusive) * planned to undergo elective, primary total unilateral total knee arthroplasty under general anesthesia key exclusion criteria: * previous deep vein thrombosis (dvt) of the leg or pulmonary embolism (pe) within the past year * any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent pulmonary embolism) that may lead to the required concomitant use of anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban, clopidogrel) that may affect study outcome or any other drug influencing coagulation (except low dose aspirin (100 mg or less)) * anticipated use of intermittent pneumatic compression devices and/or electrical/mechanical muscle stimulators post total knee arthroplasty procedure

Keywords: venous thromboembolism adhesion molecule p-selectin glycoprotein ligand 1 p-selectin venous thrombosis
autologous bone marrow mesenchymal stem cell transplantation for chronic ischemic stroke

Conditions: Stroke

Summary: stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.stem cell transplantation provides a promising approach for rehabilitation. the main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.

stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.it will brought heavy burden to patients themselves,their family and society.drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.however,in the chronic ischemic stroke,there was few methods to improve the functions.in recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. in this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. the neurological outcome will be determined after transplantation.

Eligibility criteria:
inclusion criteria: * aged 18-80 chronic ischemia stroke or patients * with stroke history of more than 6 months, less than 60 months * nihss (nih stroke scale) score of 7 or more points * internal carotid artery territory infarction measured by mri * can be hospitalized and signed informed consent * with fewer effect by traditional post-stroke treatments or rehabilitations exclusion criteria: * lacunar infarction * recurrent thrombotic diseases less than 6 months * hemorrhage stroke,brain tumor or mri show the occlusion is not in the middle cerebral artery territory * pregnant women * can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, aids, combine other tumor or special condition * penicillin anaphylaxis or some other drugs allergy * autoimmune disease * inaccessibility for follow up

Keywords: stroke bone marrow mesenchymal stem cell transplantation
patient characteristics, treatment patterns, and healthcare resource utilization of metastatic melanoma patients

Conditions: Metastatic Melanoma

Summary: this was a retrospective, non-interventional, registry study based on secondary electronic medical record (emr) data collected in helsinki and uusimaa hospital district (hus data lake), hospital district of southwest finland (vsshp data lake) and pirkanmaa hospital district (pshp data lake) as a part of their routine clinical practice. social insurance institution of finland (sii; reimbursed drug purchases) was utilized in this study to complement the medication data. the metastatic melanoma patients were stratified by first-line treatment and by hospital district.


Eligibility criteria:
inclusion criteria * patients diagnosed with metastatic melanoma (c43) during 01 january 2014 and 31 december 2021. * adult (18 years or older) at the time of diagnosis of metastatic melanoma. * resident in the corresponding hospital district(s) at the time of diagnosis of metastatic melanoma. exclusion criteria * metastasis recorded prior to 01 january 2014 (i.e. prevalent case). * record of any other cancer (the international classification of diseases, 10th revision \[icd-10\] diagnosis code starting with c, excluding c43, c77, c78, and c79) as last cancer diagnosis before metastasis. * participated in cobra (vemurafenib, temozolomide, lomustine, vincristine) trial.
clinical performance of a vaginal pessary (phyph) in vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiasis

Summary: this is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of gedea pessary in 24 adult women with vvc. on day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. patients will be examined after 7 days with respect to vvc signs and symptoms and if not cured, will receive prolonged treatment for one additional week. patients will be followed-up by telephone up to 29 days after last treatment. vaginal samples will be used for confirming diagnosis and microbiome analyzes. patient questionnaires will be used for assessing vvc symptoms, usability, and adverse events (aes).


Eligibility criteria:
inclusion criteria: * adult, post-menarchal, pre-menopausal women aged 18 years or older * diagnosis of vvc, defined as having a white or creamy vaginal discharge plus the following findings: 1. at least 2 of the following signs and symptoms of vvc that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation. 2. potassium hydroxide (koh) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts. * having decisional capacity and providing written informed consent * negative urine pregnancy test at screening * refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period * refrain from sexual intercourse or use a condom until day 7 * signed informed consent and willing and able to comply with all study requirements exclusion criteria: * patients with known or apparent signs of other infectious causes of vvc (bv, trichomonas vaginalis, neisseria gonorrhoeae, chlamydia trachomatis, herpes simplex, or human papillomavirus) at screening * patients who are pregnant or breastfeeding * patients who were treated for vvc within the past 14 days * patients who are currently receiving antifungal therapy unrelated to vvc or has taken antifungal therapy within the past 14 days * patients who have used ph-modifying vaginal products within the last 14 days * patients who have received an investigational drug in a clinical investigation within 30 days prior to screening * known/previous allergy or hypersensitivity to any product constituent or fluconazole * any medical condition that in the investigator's judgments would make the patient unsuitable for inclusion

Keywords: vaginal yeast infection candidiasis, vulvovaginal genital diseases, female vaginitis vulvovaginitis vaginal diseases
the application of a mental practice protocol in the acute inpatient rehabilitation setting

Conditions: Stroke; Upper Extremity Paresis

Summary: the purpose of this randomized controlled trial is to compare the effect of audio-guided mental practice (mp) and video-guided mp on the impairment and functional abilities of upper extremity (ue) hemiparesis following a stroke. participants are recruited from adventist healthcare rehabilitation hospital. all participants must be less than one-month post-stroke with moderate ue hemiparesis. eligible participants are randomly assigned to an experimental group, (mp or repetitive-task practice (rtp)), or the control group. the mp groups will perform either audio-guided mp or video-guided mp, five days a week, with 20 repetitions of the following tasks: wiping a table, picking up a cup, brushing hair, and turning the pages of a book. the rtp group physically performed the same tasks. the control group received traditional stroke rehabilitation. the investigators hypothesize that video mp will have greater improvements in ue impairments and functional abilities than audio mp, rtp, and/or traditional therapy.


Eligibility criteria:
inclusion criteria: * primary diagnosis of stroke * less than one-month post-stroke * hemiparesis of one upper extremity * moderate upper extremity impairment exclusion criteria: * history of prior stroke * comorbidities (severe neurological, orthopedic, rheumatoid, or cardiac impairments) * severe spasticity * severe cognitive impairments * inability to perform mental imagery * severe aphasia based on speech therapist evaluation * low english proficiency * severe pain

Keywords: mental practice stroke upper extremity hemiparesis rehabilitation interventions
prevalence and healthcare consumption of asd patients using french medico-administrative data

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is one of the neurodevelopmental disorders described in the dsm5 (american psychiatric association, 2013). this heterogeneous syndrome appears in childhood and persists throughout life with different developments from one individual to another. it is clinically characterized by the combination of deficits in social communication with restricted and repetitive behaviors. the prevalence of asd has seen a significant increase over the last 10 years, with estimates varying greatly from one country to another, ranging from 4.2/1,000 in france to 31/1,000 in iceland. in france, prevalence has been estimated by two child disability registers set up in the departments of haute-garonne (rhe31), isère, savoie, and haute-savoie (rheop), but there is no epidemiological surveillance system to estimate the national prevalence of asd in the general population. however, the production of reliable epidemiological data at the national and territorial levels is essential for addressing the needs of individuals with asd and for evaluating public policies. the main objective of our project is to estimate the annual prevalence of asd in children, adolescents, and young adults at the national and regional levels using medico-administrative databases (snds), to study its evolution over the period 2010-2019 and its geographical distribution in relation to socio-demographic indicators and healthcare accessibility. our secondary objectives are to validate an algorithm for detecting asd in the national health data system (snds) and to estimate the direct medical costs associated with asd management. the snds databases contain all medical care and treatments reimbursed for health insurance beneficiaries provided in the private or public sector. a case detection algorithm will be tested and validated on validation samples. then, the prevalence of asd will be estimated, taking into account geographical, socio-economic, and healthcare accessibility indicators, in order to study the factors associated with the significant disparity in rates observed in france and abroad. an estimate of direct medical costs will be made from the health insurance perspective. our project therefore proposes the development of reliable indicators on the management of asd in france with the aim of providing useful indicators and tools for guiding health and disability policies in france, promoting the development of appropriate interventions, and thus contributing to the improvement of the care and support of individuals with asd as well as reducing inequalities in access to healthcare for these vulnerable populations.


Eligibility criteria:
inclusion criteria: * children aged 16 years or younger * for case : with an icd-10 code for asd (f84\*) * for control : without an icd-10 code for asd (f84\*)

Keywords: administrative claims population surveillance