Kornimate/medical-research-clean huggingface dataset:
efficacy of lifestyle intervention in brca1/2 mutation carriers

Conditions: Hereditary Breast and Ovarian Cancer

Summary: the hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

brca1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. there is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. the hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Eligibility criteria:
inclusion criteria: * proven pathogenic brca1/2 mutation * age \>=18 * written informed consent exclusion criteria: * current chemotherapy of radiotherapy (inclusion 6 weeks after ctx or rx possible) * metastatic tumor disease * life expectancy \<3 years * clinically limiting cardiovascular or respiratory disease (instable cvd, heart failure stage iv, copd gold iv, maximum resting blood pressure 160/100 mmhg) * significant orthopedic disability which prevents from participating in the group interventions * severe concomitant diseases which prevents from participating in the group interventions * karnofsky index \<60 * maximum exercise capacity \<50 w * food allergies which prevent from mediterranean diet * vegan diet * body mass index \<15 kg/m2 * pregnancy * insufficient knowledge of german language * insufficient compliance * active participation in other interventional trials

Keywords: hereditary breast and ovarian cancer (hboc) brca1/2 mutation carriers mediterranean diet structured exercise training prevention
dry needlig vesus tecartherapy in low-back pain treatment

Conditions: Low Back Pain

Summary: introduction: diathermy is a new tool that could help subjects with chronic low back pain (clbp), with no studies having compared it to other interventions already investigated such as dry needling. hypothesis: diathermy is more effective than dry needling in improving pain intensity in the short term in subjects with clbp. design: randomised controlled trial methods: we will conduct a convenience sampling, with subjects receiving 2 treatment sessions with diathermy or dry needling, according to allocation. subjects will be assessed at baseline, 1 week, 1 month and 3 months after treatment for pain intensity, disability, kinesiophobia and catastrophizing. analysis of variance (anova) and moderation analysis will be performed to evaluate the results, with 95% confidence intervals (ci).

a prospective longitudinal experimental randomised controlled trial study will be conducted from august 2022 to march 2023. the study will be conducted in accordance with the recommendations of the consolidated standards of reporting trials (consort) statement,15 and in accordance with the declaration of helsinki. subjects were randomly assigned to one of the two intervention groups: diathermy. diathermy treatment was applied using the tcare power diathermy instrument (prim physio©), using a capacitive system with an intensity of 50%, with slight variation depending on patient tolerance and 500khz. the therapy will be applied for 10 minutes on each side of the patient's lumbar region, who will be positioned in prone decubitus during the intervention. the application will be active along with massage techniques. dry needling. dry needling is performed with a 4cm needle (aps dry needles®) on the most symptomatic side of the patient on palpation. to perform the technique, the patient is positioned in prone position on the couch. the physiotherapist palpates the lateral border of the lumbar iliocostalis muscle and performs the tapping technique in a latero-medial direction parallel to the stretcher. the technique is performed by applying 12 incisions. after the application of the technique, ischaemic compression shall be performed for 1 minute. patients will complete a home exercise program

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * chronic non-specific low back pain. * duration of pain of more than 6 weeks. exclusion criteria: * neurological signs or symptoms. * radicular pain. * radiating pain below the knee. * belonephobia. * traumatic processes and/or surgeries in the lumbar region in the last year. * having received physiotherapy treatment in the last 3 months. * systemic diseases such as cancer, rheumatic diseases, neurological diseases.

Keywords: back pain, dry needling, tecartherapy
prospective multicenter evaluation of a new short-access-cholangioscope for biliary duct strictures and gall stones

Conditions: Choledocholithiasis; Common Bile Duct Neoplasms; Cholestasis

Summary: karl storz gmbh (gesellschaft mit beschränkter haftung) company developed a cholangioscopic device, which is designed to give a better flexibility to the cholangioscopy tip in order to enable optimal diagnostic and therapeutic precondition. other than the conventional mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at the side of a specially developed duodenoscope (mother part) which is prepositioned distally to the control unit, near to the patient's mouth. better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres. this study is designed to test the efficiency of the device in relation to this assumption.

cholangioscopy is a subsidiary treatment in endoscopic retrograde cholangiopancreaticography (ercp), used for special issues. in the context of ercp, a long,thin shaped device is introduced through the working channel of a duodenoscope and then through the papilla into the biliary duct. inspection of the biliary duct can be used for tumor biopsies as well as for gall stone lithotripsy by laser or electrohydraulic technique. manoeuverability of cholangioscopes is limited by the length of the scope, even more, since most of the device body is stuck in the working channel. the newly designed cholangioscope by the company of karl storz gmbh is introduced through a shortened working channel. introduction of the cholangioscope is done by an innovative side port for the cholangioscope at 70 cm from the insertion tube's distal end. this leads to a better flexibility of the device tip. better manoeuverability of the device tip will lead to both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy manoeuvres. this study is designed to test the efficiency of the device in relation to this assumption.

Eligibility criteria:
inclusion criteria: * choledocholithiasis, not treatable through conventional ercp with sphincterotomy. * stricture of the biliary duct in need of histopathological investigation exclusion criteria: * aggravated or impossible access to papilla * inappropriate biliary anatomy, e.g. multiple strictures or diameter of duct \< cholangioscope impairing intubation * primary sclerosing cholangitis * coagulopathy (quick \< 50%, thrombocytes \< 50/nl)and anticoagulant medication * bad patient's condition (asa iv)

Keywords: cholangiography cholangioscopy mother-baby cholangioscope frimberger cholangioscope short access cholangioscopy ercp gallstone therapy
monitored breathing awareness therapy for insomnia disorder in older adults-2

Conditions: Insomnia

Summary: insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. advanced medical electronics, in partnership with researchers are the university of pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia


Eligibility criteria:
inclusion criteria: 1) sleep onset latency \> 30 min for at least 3 nights per week exclusion criteria: 1) unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in english (the study questionnaires are in english and do not exist in validated form for other languages). 2) cognitive impairment; cognitively impaired patients may not be able to comply with the protocol). 3) history of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder 4) upper extremity motor impairment that would preclude mbat therapy (e.g., quadriplegia).
glass ionomer sealant and fluoride varnish study to prevent early childhood caries

Conditions: Dental Caries

Summary: the goal of this project is to conduct a community-based randomized clinical trial to compare the caries prevention efficacy of fluoride varnish applied every six months vs. fluoride varnish applied every six months and fluoride releasing glass ionomer sealants applied annually to the eligible occlusal surfaces of primary molars in 3-6-year-old children.

community-based, stratified (by location) randomized clinical trial (rct) to determine the relative efficacy of topically applied fluoride varnish (fv) applications alone vs fv with fluoride-releasing glass ionomer (gi) sealants on occlusal surfaces of primary molars in reducing the caries incidence and increment in 3-6 year old children. a parallel groups design rct stratified by study site (one dental and one non-dental location) will be conducted among 596 initially 2.5- to 3-year-old children. those eligible will be randomized to one of 2 groups (fv or gis+fv) and followed for 36 months. the rct will take place at two sites serving primarily underserved, minority and low-income populations in southern california: 1) the dental facility of the san ysidro health center (syhc) located near the u.s.-mexican border serves mainly latino immigrants, and 2) the comprehensive health center - ocean view (chc-ov), in a non-dental setting in close proximity to its dental clinic, which serves latinos and african americans. both sites are part of a consortium of community clinics (syhc inc) and are located 15 miles apart from each other. annual study dental examinations will be performed by trained, calibrated, study dentists to determine caries (precavitated and cavitated) incidence and increment. children identified as needing dental care will be referred for appropriate treatment.

Eligibility criteria:
inclusion criteria: * family resides in the south bay or central san diego area * parent/guardian can consent in english or spanish * child has 1-8 caries-free primary molars (with no occlusal pre-cavitation and no restoration) * child is cooperative and behaviorally suited for the clinical trial interventions * child is a registered patient at san ysidro health center inc. exclusion criteria: * any siblings of participants * child with cavitated lesions * child with a health condition, special need, or with a complicated factor that will prevent from completing the required number of visits during a 36-month follow-up period * anything, that in the opinion of the investigator, would preclude the child from complying with the protocol or jeopardize the safety of the child while on the protocol

Keywords: children fluoride varnish glass ionomer sealant prevention
treatment of tendon injury using mesenchymal stem cells

Conditions: Lateral Epicondylitis

Summary: main purpose of this study is to evaluate efficacy and safety of allogenic adipose-derived mesenchymal stem cells(allo-asc) in treatment of tendon injury. allo-asc will be administrated to the patients with lateral epicondylitis by ultrasonographic guided injection.

injection volume depends on the size of lesion on ultrasound examination. and all injection will be done under ultrasound guidance. first the investigators will administrate 1 million cells/ml (group 1 for 6 participants). after monitoring the safety of injection for 2 weeks (the investigators will use who recommendations for grading of acute and subacute toxic effects), the investigators decide to increase the quantity as 10 million cells/ml (group 2 for participants). the investigators will compare the efficacy difference as quantity increase. for efficacy measurement, vas/modified mayo clinic performance index for elbow/lesion measurement by ultrasound will be used at 6 and 12 weeks after injections.

Eligibility criteria:
inclusion criteria: * clinically diagnosed as lateral epicondylitis (tennis elbow) * recurrent pain in spite of conservative treatment such as physical therapy, medication, steroid injection * symptom duration is over 6 months * defect in common extensor tendon can be observed under ultrasound * patient that can understand the clinical trials exclusion criteria: * patient that underwent other injection treatment within 6 weeks * some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue) * patient that enrolled other clinical trials within 30 days * history of drug/alcohol addiction, habitual smoker

Keywords: adipose derived mesenchymal stem cell allogeneic stem cell
transcranial direct current stimulation of the primary motor cortex to treat levodopa-induced dyskinesias

Conditions: Parkinson Disease

Summary: the main objective of the study is to evaluate the efficacy of 10 sessions of transcranial direct current stimulation of the primary motor cortex to reduce levodopa-induced dyskinesia


Eligibility criteria:
inclusion criteria: * patients with diagnosis of idiopathic parkinson's disease according to movement disorder society (mds) criteria and levodopa-induced dyskinesia; * age between 30 and 80 years; * ongoing therapy with levodopa; * fulfillment of requirements for the application of transcranial magnetic stimulation (tms), assessed by completion of the tms screening questionnaire. exclusion criteria: * patients unable to give informed consent; * cognitive impairment (mmse ≤ 24); * history of epilepsy; * pregnant women.
assessment of hydration status using bioelectrical impedance vector analysis

Conditions: Acute Kidney Injury; Critical Illness

Summary: the state of hyperhydration in critically ill patients with acute kidney injury (aki) is associated with increased mortality. bioelectrical impedance vector analysis (biva) appears to be a viable method to access the fluid status of critical patients but has never been evaluated in critical patients with aki. the objective of this study is to evaluate the hydration status using biva in critical patients under intensive care at the time of aki diagnosis and to correlate this measurement with mortality. a sample of 224 patients with aki will be evaluated by biva and followed until they are discharged or death in intensive care unit and the biva vectors will be analysed to define differences in hydration characteristics from each group.

patients admitted to intensive care unit (icu) will be assessed by biva at the moment of the aki diagnosis. they will be followed up to 12 weeks, until hospital discharge or death. the association between survival and hydration status, as assessed by biva in the first aki day, will be tested.

Eligibility criteria:
inclusion criteria: * patients older than 18 years who developed acute kidney injury after admission in intensive care unit exclusion criteria: * chronic kidney injury, dialysis-dependent chronic kidney injury, acute kidney injury before icu admission, kidney transplant, morbidity obesity and limb amputation.

Keywords: acute kidney injury intensive care unit bioelectrical impedance analysis
protein kinase n1 level in patients undergoing cardiac surgery

Conditions: Acute Kidney Injury; Extracorporeal Circulation; Complications; Surgery

Summary: acute kidney injury (aki) is one of the most frequent major complications in patients undergoing cardiac surgery. csa-aki is independently related to increased perioperative mortality, increased hospital and icu length of stay as well as heath care expenditure. identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. the pathophysiology of csa-aki is complex and ischemia-reperfusion injury is one of the important factors. recently, it has been shown that protein kinase n1 (pkn1) is associated with ischemia-reperfusion injury. in this study, relationship between pkn1 with the risk of csa-aki was analyzed and the predictive value of elevated level of pkn1 for early prediction of csa-aki was further evaluated.

acute kidney injury (aki) is one of the most frequent major complications in patients undergoing cardiac surgery. the incidence of cardiac surgery-associated aki (csa-aki) varies from 5% to 42% and is the second leading cause of aki (after sepsis) in the intensive care unit (icu). csa-aki is independently related to increased perioperative mortality, increased hospital and icu length of stay as well as heath care expenditure. early detection of csa-aki could improve patient outcomes and health care costs through targeted interventions. thus, identification of relevant biomarkers may lead to early diagnosis. the pathophysiology of csa-aki is complex and ischemia-reperfusion injury is one of the important factors. recently, it has been shown that protein kinase n1 (pkn1) is associated with ischemia-reperfusion injury. nowadays, little is known about relationship between pkn1 and csa-aki. in this study, relationship between pkn1 with the risk of csa-aki was analyzed and the predictive value of elevated level of pkn1 for early prediction of csa-aki was further evaluated.

Eligibility criteria:
inclusion criteria: * patients (≥18 years old) underwent on-pump cardiac surgery * admitted to icu immediately after surgery exclusion criteria: * patients younger than 18 years * with prior aki * end-stage kidney disease * need for chronic hemodialysis * pregnant patients * unable to give written consent for participation
feasibility study on litt for medical refractory epilepsy

Conditions: Epilepsy

Summary: multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (litt) ablation using the monteris neuroblate system for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for litt surgery.

monteris is sponsoring this multicenter, open-label, prospective feasibility study to characterize the performance of laser interstitial thermal therapy (litt) using the monteris neuroblate system for the treatment of drug-refractory medial temporal lobe epilepsy in subjects who are candidates for litt surgery. the neuroblate system uses precise, high-intensity laser light to initiate necrosis of abnormal brain tissue through thermal ablation while limiting injury to healthy tissue. unlike traditional brain surgery, litt does not require a large opening in the skull. subjects who meet the study eligibility criteria and sign the informed consent form will undergo the litt procedure. subjects, or their caregivers, are required to keep a seizure diary throughout the study, beginning after surgery. the study will monitor and record subjects' seizure frequency, antiepileptic medications, and physical and emotional health. subjects treated with neuroblate will have 2 years of follow-up. throughout study participation, the study investigator will continuously monitor and document both effectiveness and safety data at study appointments.

Eligibility criteria:
relevant inclusion criteria are listed below * diagnosis of unilateral medial temporal lobe epilepsy (mtle) confirmed clinically and with either (1) ictal scalp recording and mri evidence of mesial temporal sclerosis or (2) intracranial ictal onset consistent with hippocampal origin * averages 1 or more complex partial seizures or secondary generalized seizures compatible with mtle per month * on stable antiepileptic medications * meets the criteria for a medial temporal lobe resection and is a candidate for litt * 18 years or older at the time of consent relevant exclusion criteria are listed below * previous diagnosis of psychogenic/non-epileptic seizures * previous diagnosis of primary generalized seizures * iq less than 70 * subject has a mri-incompatible implanted electronic device or any metallic prosthesis or implant for which brain mri is contraindicated

Keywords: epilepsy medial temporal lobe epilepsy seizure neuroblate litt quality of life
acute mesenteric ischemia, reality in catalonia

Conditions: Acute Mesenteric Ischemia

Summary: acute mesenteric ischaemia (ami) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, but not very extended. the aim of this study is to analyse the results of the patients admited with an ami in catalonia.

acute mesenteric ischaemia (ami) is a notorious disease with a high mortality from 50 to 80%. even though ami is a relatively rare condition (1:1,000) the incidence rises exponentially with increasing age, in patients older than 75 years, the incidence of ami has been reported higher than that of acute appendicitis. ami patients benefit from early assessment in a surgical unit with capabilities to definitive management. the diagnosis and management of ami are truly multidisciplinary, requiring high index of suspicion and awareness from emergency department physicians, preferably computed tomography angiography with precise interpretation, but usually this is not the truth reality and the diagnostic is delayed as well as the treatment, and the management is not multidisciplinary. the aim of this study is to analyse the management and results of the patients admitted with an ami in catalonia from november 2024 to april 2026.

Eligibility criteria:
inclusion criteria: * diagnostic of acute mesenteric ischemia exclusion criteria: * chronic mesenteric ischemia * ischemic colitis * bowel obstruction strangulation * inflammatory bowel necrosis

Keywords: mesenteric ischemia acute mesenteric ischemia abdominal pain elderly complications mortality