Kornimate/medical-research-clean huggingface dataset:
possibilities and limitations of a new method for the measurement of spine dynamics during gait

Conditions: Scoliosis

Summary: the full body marker sets that are typically used in opto-electronic 3d gait analyses either disregard the spine entirely or regard it as a rigid structure. therefore, the purpose of this study is to identify the possibilities and limitations of an enhanced trunk marker set for the measurement of spine dynamics during gait in adolescents with and without structural spine deformities. it has been hypothesized that the enhance trunk marker set: 1. is a valid method for the measurement of spine deformations in the sagittal, frontal and indirectly transverse planes. 2. is an applicable and reliable method for the measurement of spine dynamics during gait in healthy adolescents and in patients with structural deformities such as seen in scoliosis. 3. is sensitive enough to distinguish the spinal movement pattern during gait measured in scoliosis patients from the one measured in healthy adolescents. to verify the hypotheses, the following measurements will be carried out: * biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients. * instrumented gait analysis with a standard full body marker set and the enhanced trunk marker set in scoliosis patients and healthy controls.


Eligibility criteria:
scoliosis patients: inclusion criteria: * adolescent idiopathic scoliosis * able to walk a distance of minimum 50 meters barefoot and without any assistive device exclusion criteria: * other types of scoliosis (e.g. of neurological origin) * previous treatment of scoliosis (conservative or surgery) * injuries of the locomotor system which led to persistent deformities healthy controls: exclusion criteria: * any pathologies or diseases affecting the locomotor system * injuries to the locomotor system which led to persistent deformities * obesity (\> 95th bmi-per-age percentile) * leg length discrepancy (more than 1% of body height)
the effects of a self-management intervention on low literacy patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: purpose: to determine the role health literacy plays in the care continuum for chronic obstructive pulmonary disease (copd) and the effect of a self-management intervention on inhaler technique use, time spent on self-management, and knowledge for copd patients with low literacy. participants: the investigators will recruit patients from the university of north carolina at chapel hill ambulatory care center (acc) who have a diagnosis of copd. procedures (methods): potential subjects with copd will be identified through pharmacy claims data, clinic billing data and the electronic medical record. eligibility will be prescreened by a research assistant (ra) using the electronic medical record prior to approaching potential subjects for consent. for the first part of the study, consenting subjects will complete a baseline health literacy assessment, a questionnaire, an inhaler technique assessment, and a diary of time spent in self-management activities. pulmonary function tests (pft) will be performed on all participants for whom pfts have not been conducted within the previous 12 months. the questionnaire will include measures of copd-related knowledge, self-management techniques, quality of care, access, quality of life, costs, healthcare utilization, exacerbations, and basic demographic information. the inhaler technique assessment will be administered by the research assistant using a pre-established protocol. the research assistant will abstract additional data from the medical record to assess the quality of care based on adherence to recommended copd care guidelines. for the second part of the study, participants will be randomized to control and intervention arms. the self-management intervention will be an interactive experience, delivered by a trained research assistant, targeting self-management skills (inhaler use, using an action plan, etc), smoking cessation, and exercise/pulmonary rehabilitation. those randomized to the control group will receive usual care. all participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique, copd-related knowledge, and time spent in self-management.


Eligibility criteria:
inclusion criteria: * are age 18 years or older and, * have been diagnosed with copd * are active patients in the general internal medicine or pulmonary clinics at the ambulatory care center * are being treated with inhaled medication for their copd exclusion criteria: * non-english speaking (intervention will be available in english only) * participants unable to complete the study (either with or without assistance) * patients who are currently experiencing an exacerbation

Keywords: health literacy self-management inhaler technique
an open-label extension of the study xen496 (ezogabine) in children with kcnq2-dee

Conditions: Epilepsy; Epilepsy in Children; Epilepsy; Seizure; Disease; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Summary: to assess the long-term safety and tolerability of xen496 in pediatric subjects with kcnq2 developmental and epileptic encephalopathy (kcnq2-dee) who had participated in the primary study (xpf-009-301).

this is an open-label, long-term extension study of xen496 for the treatment of seizures in subjects with kcnq2-dee, that will be open to eligible subjects who participated in the primary study, xpf-009-301. the primary objective is to assess the long-term safety of xen496. a double-blind transition/titration period will be used to maintain blinding to the treatment allocation in the primary study (xpf-009-301). after completion of the blinded transition/titration period, subjects will receive the open label study drug at their optimal dose for approximately 35 months.

Eligibility criteria:
inclusion criteria: * subject completed participation in the primary study, xpf-009-301. a subject who withdraws from the primary study due to meeting protocol-specified worsening criteria will be considered as having completed participation in the primary study. * the caregiver is willing and able to be compliant with diary completion, visit schedule, and study drug administration. * subject's caregiver achieved a minimum of 85% compliance with daily diary completion during both baseline and the double-blind period of the primary study. exclusion criteria: * any adverse event(s) or serious adverse event(s) during the primary study xpf-009-301, which in the opinion of the investigator and sponsor's medical monitor, would preclude the subject's entry into the ole study. * a clinically significant condition or illness, or symptoms other than those resulting from kcnq2-dee, present at screening/baseline that, in the opinion of the investigator, would pose a risk to the subject if s/he were to enter the study. * any conditions that were specified as exclusion criteria in the primary study, xpf-009-301. * it is anticipated that the subject will require treatment with at least 1 of the disallowed medications during the study. * any change in cardiac rhythm or atrioventricular conduction in the primary study that, in the investigator's opinion, is a significant risk to subject safety.

Keywords: xen496 ezogabine retigabine encephalopathy seizure kcnq2 epik
comparative study of zonisamide and carbamazepine as an initial monotherapy: efficacy and safety evaluation

Conditions: Epilepsy

Summary: the purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

to compare efficacy and safety between the zonisamide group and the carbamazepine group. the zonisamide group will be divided into 2 subgroups: slow-titration group and fast-titration group to find out optimum titration of zonisamide. this study will proceed through 25\~27 weeks.

Eligibility criteria:
inclusion criteria: 1. epilepsy patients over 15 years old. 2. occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months. 3. patients who have not taken antiepileptic drugs (aeds) in recent 3 months. 4. female who can be in the month of pregnancy should agree to prevent conception. 5. patients who agree with informed consent form. exclusion criteria: 1. patients who have myoclonic seizures and/or absence seizures. 2. patients who have progressive central nervous system (cns) disorder. 3. patients who have serious systemic disorder. 4. upward of doubled normal serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) level and/or tripled blood urea nitrogen (bun)/creatinine levels. 5. patients who have renal stones. 6. medical history of medicinal poisoning and/or alcoholism. 7. patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.
efficacy of chemotherapy combined with regional hypothermia in advanced malignant melanoma patients with progressive soft tissue metastases

Conditions: Advanced Metastastic Malignant Melanoma; Refractory to First-Line Chemotherapy Irresectable Progressive Soft Tissue Metastases

Summary: the incidence of malignant melanoma continues to rise throughout the world. approximately 12 in 100,000 germans are diagnosed with malignant melanoma per year. malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease. while treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (dtic) eventually combined with other chemotherapeutic agents e.g., cisplatin or bcnu. the duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established. to study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 * histologically proven malignant melanoma with advanced inoperable soft tissue metastases * progressive disease upon systemic first-line chemotherapy * 2 or more bidimensionally measurable soft tisue lesions * who performance status (ecog) of 2 or more * life expectancy of 8 weeks and more * prior informed consent exclusion criteria: * participation in other therapy studies * pregnancy or breast feeding * concomitant clinically significant infection * cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm) * lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)

Keywords: malignant melanoma hyperthermia chemotherapy
safety of early discharge following low risk myocardial infarction

Conditions: Myocardial Infarction

Summary: * objectives: the primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk st-elevation myocardial infarction (stemi), treated with primary percutaneous coronary intervention (ppci), compared to a conventional strategy. * methodology: unicentric, randomized, controlled, non-inferiority and open label clinical trial. the investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). inclusion criteria will be: low risk (zwolle risk score ≤3) stemi treated with ppci within 24 hours from symptoms onset. exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the gusto criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. sample size will be 1558 subjects (n=779 per group). the investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. the primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. the secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire sf-36. finally, the investigators will analyze the degree of compliance with the european society of cardiology guidelines on stemi and the rate of hospitalization-related complications. follow up will be at 30 days.


Eligibility criteria:
inclusion criteria: * low risk (zwolle risk score ≤3) stemi treated with ppci within 24 hours from symptoms onset * informed consent exclusion criteria: * arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block) * mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis) * severe or moderate bleeding (according to the gusto criteria) * complications related to vascular access of the procedure * acute kidney failure * infection * heart failure

Keywords: myocardial infarction primary percutaneous intervention prognosis early discharge
the effectiveness of a stress incontinence care protocol

Conditions: Stress Incontinence, Female; Nursing

Summary: this study seeks to contribute to nursing practices by developing and stress incontinence care protocol with the help of the star model and implementing this care protocol for the purpose of standardizing patient care outcomes.

to identify the effectiveness of a care protocol developed using the star model on outcomes in female patients with stress incontinence. information and evidence needs to be translated into nursing practice and applied to clinical decision-making in stress incontinence cases. evidence-based study models such as the star model provide guidance on using evidence to develop clinical guidelines and care protocols. the star model is designed to improve patient outcomes by creating a bridge between research and clinical practice. there is currently no published stress incontinence care protocol based on the star model. although there is one published study of a care protocol for urinary incontinence, this protocol was not drawn up on the basis of an evidence-based model. women that matched the sample criteria were recruited into the study. after their consent was obtained, the women were randomized into an intervention and a control group. the women in the intervention group were provided care according to stress incontinence care protocol. the control group received no intervention during the eight-week intervention period.

Eligibility criteria:
inclusion criteria: * the inclusion criteria were being female, ≥ 18 years, having an initial diagnosis of si, being literate, having no sensory disorder affecting communication, and agreeing to participate in the research exclusion criteria: * the exclusion criteria were pregnancy, presence of a urinary tract infection and previous treatment for si. the removal criteria were patient non-compliance with the protocol, failure in contacting the patient and the patient's wish to withdraw from the study.

Keywords: nursing evidence-based practice star model stress incontinence nursing care protocol female
the clinical application of clostridium butyricum miyairisan for motor and non-motor symptoms in parkinson's disease

Conditions: Clostridium Butyricum Miyairi; Parkinson Disease

Summary: this is an open-label, single-center, non-randomized study to assess the efficacy of clostridium butyricum miyairi on the motor and non-motor symptoms of parkinson's disease

the physician will explain the trial procedures in the outpatient, and then obtain the written informed consent to start the interview. and randomly divided into experimental and observation groups, and according to the timing of taking miyarisan, scale evaluation and sample collection.

Eligibility criteria:
inclusion criteria: * male or female over 20 years old, diagnosed with parkinson's disease. exclusion criteria: * people with parkinson's disease dementia, or lactose intolerance
long-term health outcomes of ae casualties

Conditions: Long Term Adverse Effects; Combat Disorders

Summary: this study involves individuals who are currently participating in the wounded warrior recovery project and underwent aeromedical evacuation (ae) due to injury during deployment in iraq or afghanistan. the goal of the study is to understand how best to engage wounded warriors in research activities studying long-term health. based on the results from this study, the investigators can plan a larger study with the goal to better understand the long-term health conditions of individuals who were injured in combat and improve patient care. as part of the study, participants will be asked to provide two sets of lab work over the course of a year. each set of lab work will include one blood draw, one urine sample, and height, weight, and blood pressure measurements. in order to track long-term health, information from participants' lab work will be linked with study-related health data, as well as surveys they have completed with the wounded warrior recovery project (wwrp).


Eligibility criteria:
inclusion criteria: 1. combat injury during or after october 2001 2. aged \> 18 years 3. listed in emed 4. underwent ae 5. enrolled in wounded warrior recovery project exclusion criteria: 1. non-battle injury 2. not listed in emed 3. combat injury before october 2001 4. did not undergo ae 5. not enrolled in wounded warrior recovery project

Keywords: aeromedical evacuation combat injury
autologous muscle fiber fragment injections

Conditions: Fecal Incontinence

Summary: to regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (mpcs)

the study hypothesizes that efficient re-assembly of injected fragments within host muscle tissue along the fiber direction of native muscle will be induced. it is anticipated that these fiber fragments would integrate into the host vascular and neural network.

Eligibility criteria:
inclusion criteria: * 18 years of age * participants must experience 4 or more fecal incontinence (fi) episodes per 2 week period * participants must score \>10 on cleveland clinic fecal incontinence severity scoring system (ccis) * participants must have had symptoms for at least 12 months * participants who have failed standard medical and surgical treatments for fi * participant will undergo anorectal manometry (arm) testing * participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees * women of childbearing potential must use acceptable contraceptives during this study exclusion criteria: * participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage * participants with pre-existing ano-rectal pain of any cause * participants with incontinence of flatus only * chronic watery diarrhea which is the primary cause for fecal incontinence * acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae) * presence of anorectal tumors * active proctitis or inflammatory bowel disease * previous injection of internal anal sphincter (ias) with bulking agents * participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment * participants with a defined bleeding disorder diagnosed and treated by a hematologist * other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids * participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction * women who are pregnant, breastfeeding, or have had a child within the last year * participants with a history of unstable cardiac function (new york heart association functional classification iii or iv) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (cr \>1.5 mg/dl or on dialysis) or uncontrolled diabetes (hemoglobin a1c \> 8 mg/dl) * participants with anemia (hemoglobin \ 2 times normal) or increased bilirubin \>1.5mg/dl * participants with hepatitis b or c, or human immunodeficiency virus (hiv)-1 or 2 * rectal prolapse * vaginal prolapse beyond the hymen * unable to understand informed consent information even with provision of a medical translator

Keywords: low anal pressures passive incontinence bowel movements sphincter muscle
source 3: observational study to evaluate safety and performance of sapien 3 thv system in real life practice

Conditions: Aortic Stenosis

Summary: this is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites. 300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. echocardiogram and angiogram will be taken routinely.

the purpose of this registry is to provide clinical outcome and safety information on patients that will be treated with the edwards sapien 3 transcatheter heart valve and delivery devices for severe, symptomatic calcific aortic stenosis. in addition, the information collected will serve post market safety and surveillance regulatory obligations. consecutive patient data will be collected at baseline, procedure, discharge, after discharge (at approx. 30 days post-index procedure), 12 months post-index procedure and annually thereafter up to 5 years post-implant according to usual practice at site.

Eligibility criteria:
inclusion criteria: * patient suffering from severe, symptomatic, calcific aortic stenosis * sts score ≥ 8 * logistic euroscore ≥15 exclusion criteria: * congenital unicuspid or congenital bicuspid aortic valve * evidence of intracardiac mass, thrombus or vegetation * active infection or endocarditis

Keywords: sapien 3 thv tavi transfemoral transaortic transapical aortic valve