Kornimate/medical-research-clean huggingface dataset:
observational study of digital biomarkers of myotonia and gait in adults and children with myotonic dystrophy

Conditions: Myotonic Dystrophy 1

Summary: the goal of this observational study is to assess movement in individuals with myotonic dystrophy type 1 (dm1) and type 2 (dm2) using digital biomarker tools. the long-term aim of this study is to incorporate these outcomes into clinical trials of dm1 and dm2 therapies. participants will complete a series of assessments that allow for researchers to measure hand myotonia and walking quality, including a video hand opening test (vhot), grip strength, 10 meter walk/run test, 6 minute walk test, timed up and go (tug), motor function measures-32 (mfm-32) test, and more. these assessments may be recorded to detect and map participants motion and walking patterns. several patient reported outcome (pros) questionnaires will also be recorded. participants may also be asked to monitor exercise and sleep activity at home using an actigraph wearable device. this study is divided into 2 parts: part a consists of a single visit. part b consists of a 1-year longitudinal study with 3 clinical follow-up visits.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * age 12-90 years old at the time of informed consent * genetic confirmation of dm1 or dm2 * ability to comply with study assessments * clinically apparent myotonia equivalent to hand opening time of at least 2 seconds, in the opinion of the investigator * ambulatory (orthoses allowed, canes and walkers not allowed) and able to walk at least 25 meters at screening exclusion criteria: * ongoing medical condition (e.g. wasting or cachexia, severe anemia) that would, in the opinion of the investigator, interfere with the conduct or assessments of the study * significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression ≤ 90 days of screening, which in the opinion of the investigator may interfere with the study procedures * treatment with an investigational drug, biologic agent, or device within one month of screening, or 5 half-lives of investigational agent, whichever is longer * inability to comply with study requirements * other unspecified reasons that, in the opinion of the investigator or the sponsor, make the participant unsuitable for enrolment

Keywords: myotonic dystrophy 1 dm1 digital biomarkers hand myotonia gait observational study actigraph syde
noninvasive transcranial direct current stimulation to improve executive functions in stroke patients. modul-exe clinical trial.

Conditions: Transcranial Direct Current Stimulation

Summary: this study will examine the possible effects of tdcs (transcranial direct current stimulation) treatment to the left dlpfc on executive functions in patients with an acute stroke affecting the frontal lobe or the basal ganglia. the study will include 40 acute stroke subjects. participants will undergo a global cognitive assessment with the moca test and a specific assessment of executive functions with the abbreviated wisconsin test, the five digit test and the digit span evaluation (a subtest from the wechsler intelligence scale for adults-iv). participants will then undergo real or sham stimulation with anodal tdcs combined with cognitive training of the main executive functions: working memory, inhibitory control and cognitive flexibility. after a 10-session intervention, a the baseline cognitive assessment will be repeated and subsequently, a follow-up of up to 12 months will be carried out.


Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis, by means of cranial mri or ct scan, of ischemic/hemorrhagic stroke, involving the frontal cortex or its subcortical connections (basal ganglia), in one or both hemispheres. * the stroke occurred during the 3 months prior to inclusion in the study. * cognitive impairment with a dis-executive profile demonstrated by a score \> 26 in the spanish version of the moca test, adjusted for the number of years of formal education. * patients with functional independence prior to the stroke, defined as a modified rankin scale score \< 3 points. * the patient gives informed consent. exclusion criteria: * presence of other pathologies that may be a potential cause of disability or cognitive impairment. * moderate or severe aphasia that hinders communication. * severe sensory and/or motor impairments that prevent the completion of the evaluation and/or intervention processes. * presence of extensive vascular leukopathia (leukoaraiosis grade 3, 4). * history of epilepsy or seizures. * presence of severe systemic pathology, including cardiac, hepatic or renal failure, active neoplasia. * failure to meet any of the inclusion criteria recorded in the screening for electrical stimulation of the university of göttingen. * presence of: 1. pacemaker. 2. electrical and/or metallic implants. 3. pregnancy. 4. anticonvulsant medication. 5. tattoos in the area of electrode placement.
impact in life quality of a educational program for prevention of occupational musculoskeletal disorders in workers

Conditions: Occupational Musculoskeletal Disorders; Healthy

Summary: the study consists of evaluating the efficacy of an educational program for prevention of occupational musculoskeletal problems in workers. it is a randomized clinical trial with parallel groups and blinded evaluator, with a control group not submitted to the educational program, but that received a program for general orientation in health. the primary outcome was the change of the quality of life measured by means of medical outcomes study 36-term short health survey (sf-36), that it is a generic instrument of evaluation of the quality of life, translated and validated in portuguese of brazil.


Eligibility criteria:
inclusion criteria: * all workers from a specific company, including administrative and production sections. exclusion criteria: * workers absent from the workplace during all the study period.

Keywords: repetitive strain injury quality of life functional capacity workers
swallowing difficulties with medication intake and coping strategies in patients with systemic sclerosis

Conditions: Systemic Sclerosis; Deglutition Disorders; Adherence to Medication Regime; Coping Behaviour; Scleroderma, Systemic

Summary: the purpose of this study is the validation of a newly developed self-report questionnaire which aims at determining the prevalence, location and intensity of swallowing difficulties with drug intake, and describing the impact on medication regimen focusing on coping strategies (swameco).

the study aims at investigating a cohort of patients with diagnosed systemic sclerosis using the newly developed self-report swameco-questionnaire. the self-report questionnaire is sub-divided into four sections: detection of swallowing difficulties, coping strategies, risk factors to develop swallowing difficulties and adherence to medication. this study involves patients with systemic sclerosis. systemic sclerosis often is accompanied by swallowing disorders which may lead to issues in handling medication regimen with risks for patient safety.

Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis for systemic sclerosis * treated in the reha rheinfelden * signed informed consent * german language skills exclusion criteria: -

Keywords: self-reported questionnaire swallowing disorders systemic sclerosis drug therapy adherence to medication regime coping strategy pharmaceutical care patient safety patient oriented care
efficacy and safety of shr-1209 combined with lipid-lowering agents in patients with hypercholesterolemia

Conditions: Non-familial Hypercholesterolemia; Mixed Hyperlipidemia

Summary: to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of shr-1209 subcutaneous administration in patients with non-familial hypercholesterolemia and mixed hyperlipidemia after lipid-lowering therapy


Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤80 on the date of signing the informed consent, male or female; 2. the report of ldl-c should be higher than the ideal lipid-lowering target according to ascvd history; 3. fasting triglycerides less than equal to 5.6 mmol/l； 4. understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent. exclusion criteria: 1. have the following diseases or treatment history : (1) have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of familial hypercholesterolemia according to simon broome criteria;(3) cardiac function as defined by the new york heart association (nyha) grade iii-iv at screening or randomization or latest detected lvef\<30%;(4) cvd events within 3 months; (5) uncontrolled hypertension; (6) prior exposure to recaticimab or other pcsk9 inhibitors; (7) inadequate organ functions. 2. any of the laboratory indicators met the following criteria at screening or at randomization :(1) alanine aminotransferase (alt) or aspartate aminotransferase (ast) exceeding 3 times the upper limit of normal (uln), or total bilirubin exceeding 2 times the upper limit of normal (uln);(2) creatine kinase (ck) exceeds 3 times the upper limit of normal value (uln); 3. general conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) fertile female subjects who did not use contraception within 4 weeks before screening; or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) women who are pregnant or lactating. 4. the investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.
ultrasonographic evaluation of the effectiveness of different techniques

Conditions: Ultrasound Evaluation of the Effect of Manual Lymph Drainage; Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) occurs as a result of compression of the median nerve under the transverse ligament along the carpal tunnel. the main cause of median nerve compression and carpal tunnel syndrome is increased volume in the carpal tunnel. the pressure that edema puts on the nerve must be controlled in the early period. edema that persists beyond the inflammatory process can contribute to the fibrotic stage, delay healing, and even cause complications such as pain and stiffness. manual lymphatic drainage (mld) is a specialized technique that involves gentle massage techniques and follows lymphatic pathways from proximal to distal and then from distal to proximal. on the basis of this concept; increasing circulation by stimulating the lymph system, removing biochemical residues, reducing edema and pain, and regulating sympathetic and parasympathetic system responses. it is known that mld rapidly regulates lymphatic circulation by creating a change in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may form after a traumatic situation, reducing edema that predisposes to pain, and increasing mobility. nerve gliding exercises are another method used in treatment. by providing a sliding movement of the tendons and median nerve in the distal-proximal direction, mobilization of the surrounding soft tissues is achieved and dynamic ischemia is terminated. the aim of this study is to determine the effectiveness of manual lymphatic drainage and nerve mobilization on clinical and ultrasonographic findings in carpal tunnel syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate carpal tunnel syndrome on electrodiagnostic examination * being between 20-55 years old * volunteering to participate in the treatment to be given exclusion criteria: * have a systemic inflammatory disease * having any disease that may cause polyneuropathy, such as diabetes mellitus * cognitive impairment * receiving psychotherapy * having a pacemaker * illiterate * having a disease affecting the central nervous system * having a hearing problem * any skin disease that would contraindicate manual lymphatic drainage * arterial or venous circulatory disorders that would contraindicate manual lymphatic drainage * nsaid drug use

Keywords: ultrasonographic evaluation carpal tunnel syndrome manual lymph drainage edema pain
clinical utility of ercp guided cholangiopancreatoscopy with the spyglass ds

Conditions: Biliary Tract Disease

Summary: this is a prospective evaluation of the clinical utility of the new cholangioscopy platform spyglass ds. the aims of this study are to prospectively document the clinical utility and technical aspects of ercp with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.

cholangioscopy allows for direct visualization of the bile and pancreatic duct. in 2006, the spyglass direct visualization system for per-oral cholangiopancreatoscopy was introduced and since then has been shown to provide incremental diagnostic and therapeutic benefits. the main limitations of the original spyglass platform are fiber optic visualization system, limited tip angulation, square cut spy scope tip, and complex multi-component setup. a new generation cholangioscopy platform, spyglass ds is currently in clinical use. the new system addresses many of the shortcomings of old platform including digital optics, improved tip angulation, tapered tip and simplified set up. it is unclear at this time whether this technical improvement will translate into better outcomes. therefore, the investigators want to study the clinical utility of spyglass ds by prospectively collecting data on the clinical outcomes of patients undergoing cholangioscopy with spyglass ds as part of their routine medical care.

Eligibility criteria:
inclusion criteria: * participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care exclusion criteria: * failure to provide informed consent * any contraindications to endoscopy

Keywords: main pancreatic duct
does ultrasound assessment for extravascular lung water and ivc measurement affect outcomes in inpatient heart failure management?

Conditions: Acute Decompensated Heart Failure

Summary: this study evaluates daily pocus/fcu exams on patients admitted for acute decompensated heart failure with primary end point of acute kidney injury while in hospital.

patients with admitted to hospital with acute decompensated heart failure (adhf) suffer a significant morbidity and premature mortality. administration of intravenous (iv) diuretics is largely guided by clinical judgment based on physical exam, net fluid measurement, changes in daily weights and chest x-ray findings. the key objective is to promote adequate diuresis while improving symptoms, without compromising renal function. laboratory tests demonstrating hemo-concentration, increasing bun, and increasing creatinine have been proposed as positive prognostic indicators in patients receiving iv diuretic therapy but these methods suffer from inadequate predictive value. observational studies have identified worsening renal failure (wrf) in patients admitted for heart failure as an important clinical entity associated with worsening clinical outcomes. point of care ultrasound (pocus) has the potential to fill an unmet need for monitoring patients recieving iv diuretic therapy. pocus provides clinicians with immediate diagnostic information obtained and interpreted at bedside that can augment and enhance the physical examination. numerous studies have examined pocus assessment of pulmonary edema and measurement of the inferior vena cava (ivc) to estimate hemodynamic parameters for patients with acute decompensated heart failure (adhf). no study to date has examined pocus effect on clinical outcomes.

Eligibility criteria:
inclusion criteria: * age \>18 admitted for acute decompensated heart failure exacerbation as primary admission diagnosis from emergency department to general medicine ward that are administered diuretic therapy expected to be admitted for two days or more. exclusion criteria: 1. decline consent for study 2. if admitted and research team not available for consent and initial evaluation prior within 6 hours of first diuretic administration 3. patients in whom diuretics will not be utilized (i.e. anuric, esrd on hd) 4. inability to assess ivc (surgical anatomy, body habitus, ileus, etc.) 5. patients admitted to icu 6. patients currently on positive pressure ventilation (bipap) 7. patients discharged from the emergency department 8. patients discharged prior to evaluation by the pocus team

Keywords: point of care ultrasound focused cardiac ultrasound heart failure inferior vena cava pocus chf fcu acute heart failure decompensated heart failure
the value of preoperative diagnosis and prognostic prediction based on radiomics of giant cell tumor of spine

Conditions: Spinal Tumor

Summary: 1. exploit ct (plain scan), enhanced ct and fmri based radiomic biomarkers, explore their correlation with the prognostic molecular markers of spinal gctb(p53/vegf/rank/rankl...), and help accurate diagnosis of gctb. 2. exploring a new method of preoperative risk stratification for spinal gctb, and establishing radiomic model combined with clinical features. exploring the gctb biological behavior prediction model and the prognosis prediction of gctb.

this study intends to conduct a systematic review of patients with spinal gctb who have undergone standardized imaging (ct or mri) in our hospital since 2006 to obtain case samples, conduct standardized clinical and imaging data extraction and analysis, and fully integrate histopathology and clinical follow-up results. to preliminarily explore the value of postoperative imaging-based radiomics markers in the preoperative precise diagnosis of spinal gctb, risk stratification and prediction of tumor biological behavior.

Eligibility criteria:
inclusion criteria: * patients diagnosed with spinal gctb who underwent surgical resection or biopsy without preoperative chemotherapy or radiotherapy were included in this study. exclusion criteria: * i) the ct scan was performed more than 1 week before surgery ii) poor image quality. such as surrounding structure artifacts; iii) the remaining tumor tissue in the postoperative paraffin specimen is too little to be used for reanalysis; iv) cases with negative h3f3a (h3 histone, family 3a) staining were excluded; v) incomplete clinical information.

Keywords: giant cell tumor of bone radiomics recurrence spine tumor
evaluation of an anti-trem-1 treatment on an ex vivo human intestinal model

Conditions: Inflammatory Bowel Diseases

Summary: time is an observational study performed on uc and cd patients under endoscopic surveillance for monitoring the clinical activity of their disease. the main objective of the study is to confirm the therapeutic potential of trem-1 in inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * patients between 18 and 60 years * signed informed consent * ulcerative colitis (uc) patients with active disease * crohn's disease (cd) patients with active disease exclusion criteria: * uc or cd patients in remission * patients between 18 and 60 years without informed consent

Keywords: ibd
a feasibility study on ultrafiltration and blood volume measurements

Conditions: Acute Decompensated Heart Failure; Fluid Overload

Summary: the objective of this feasibility study is to characterize the performance of the aquadex flexflow® system with the hematocrit (hct) feature in conjunction with daxor's blood volume analyzer (bva-100). the study will monitor blood volume changes during ultrafiltration (uf) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (adhf).

the study will measure blood volumes at various time intervals using the bva-100 for comparison to corresponding readings of hematocrit (hct) levels from the aquadex flexflow hct sensor. establishing a correlation between bva measurements (off-line measurements) and hct sensor measurements (on-line measurements) may enable the use of the bva-100 to guide ultrafiltration therapy by the aquadex system for fluid removal. bva-100 measurements would be used at baseline to accurately determine patient suitability for fluid removal and while hct measurements would be used to monitor blood volume changes during ultrafiltration therapy, potentially guiding the removal of fluid in subjects hospitalized with adhf.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. subject or legally authorized representative is able to provide appropriate consent to participate 3. hospitalized for adhf with fluid overload as indicated by at least two of the following: 1. pitting edema ≥ 2+ of the lower extremities 2. jugular venous distention \> 8 cm 3. pulmonary edema/pleural effusion on chest x-ray 4. paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea 5. respiration rate ≥ 20 per minute exclusion criteria: 1. unable or unwillingness to provide informed consent or to comply with study requirements 2. subject who is pregnant 3. acute coronary syndrome 4. known bilateral renal artery stenosis 5. serum creatinine \> 3.0 mg/dl at the time of presentation 6. subject receiving ongoing active treatment with diuretics (up to 2 doses of iv diuretics are permitted before initiation of ultrafiltration therapy) 7. systolic blood pressure ≤ 90 mmhg 8. poor or unattainable central access 9. has bleeding disorder 10. contraindications to systemic anticoagulation 11. allergic to iodine, albumin, or iodinated i-131 albumin 12. active myocarditis or hypertrophic obstructive cardiomyopathy 13. severe uncorrected valvular stenosis 14. complex congenital heart disease 15. systemic infection 16. previous organ transplant 17. enrollment in other clinical trials 18. life expectancy ≤ 6 months