Kornimate/medical-research-clean huggingface dataset:
low dose thrombolysis, ultrasound assisted thrombolysis or heparin for intermediate high risk pulmonary embolism

Conditions: Pulmonary Embolism

Summary: open label clinical randomized trial comparing three strategies for managing acute intermediate-high risk pulmonary embolism

trial acronym: stratify background: intermediate-high risk pulmonary embolism (pe) is associated with a significant risk of death or hemodynamic deterioration. the optimal treatment strategy should balance efficacy in reducing thrombus burden and hemodynamic compromise with risk of complications, in particular bleeding. previous studies have investigated conventional high-dose, short term thrombolysis by (rtpa), finding a reduction in risk hemodynamic deterioration, but no reduction in mortality and a substantial increase in significant bleeding complications. catheter based techniques and low dose thrombolysis may offer lower risk of complication with reasonable efficacy. such studies have not been performed in rcts with a reasonable sample size, and no study have compared low dose intravenous thrombolysis and catheter based techniques. the current trial addresses this paucity of data by randomizing patients to one of three treatment modalities: intervention: 1:1:1 randomization, stratified for site to * ultrasound assisted thrombolysis (usat) with low dose thrombolysis (20 mg of rtpa, alteplase) over 6 hours plus unfractionated heparin (ufh) or low molecular weight heparin (lmwh) within 12 hours of randomization * intravenous low dose thrombolysis (20 mg of rtpa, alteplase) over 6 hours plus ufh or low molecular weight heparin (lmwh). * ufh or low molecular weight heparin (lmwh) only (with option for conventional thrombolysis according to local protocols for hemodynamic deterioration) design: regional collaborative, randomized trial with 1:1:1 allocation of 210 patients with acute intermediate-high risk pe with no absolute contraindications to thrombolysis

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. informed consent for trial participation 3. intermediate high-risk pe according to esc criteria 4. thrombus visible in main, lobar or segmental pulmonary arteries on ct angiography 5. 14 days of symptoms or less exclusion criteria: 1. altered mental state (gcs \< 14) 2. no qualifying ct angiography performed (\> 24 hour since ct angiography) 3. females of child bearing potential, unless negative hcg test is present 4. thrombolysis for pe within 14 days of randomization 5. thrombus passing through patent foramen ovale (risk of paradoxical embolism) 6. ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and noac allowed) 7. comorbidity making 6 months survival unlikely 8. absolute contraindications for thrombolysis 1. hemorrhagic stroke or stroke of unknown origin at any time 2. ischemic stroke in the preceding 6 months 3. central nervous system damage or neoplasms 4. recent major trauma/surgery/head injury in the preceding 3 weeks 5. gastrointestinal bleeding within the last month 6. known bleeding risk
observational multicenter non-interventional study on copd patients treatment strategies at the time of hospital discharge and within 12 months of follow-up on an outpatient primary care basement

Conditions: COPD

Summary: the study is an observational multicenter descriptive study. it is planned to enroll approximately 1250 subjects with severe and very severe copd hospitalized for the reason of copd exacerbation into departments of pulmonology or therapy. the study will be conducted in approximately 20-25 institutions of treatment and prevention in russian federation and will include about 50 to 60 subject at each clinical site.

the study is an observational multicenter descriptive study. it is planned to enroll approximately 1000 subjects with severe and very severe copd hospitalized for the reason of copd exacerbation into departments of pulmonology or therapy. the study will be conducted in approximately 20-25 institutions of treatment and prevention in russian federation and will include about 50 to 60 subject at each clinical site. this is an observational study, so there is no treatment protocol or subjects' management recommendations required. the study subjects receive medical treatment according to the routine practice for their disease in russian federation. a subject's participation in this clinical study should not affect character and amount of care provided according to the routine clinical practice. the study includes 5 clinical visits: study enrolment visit, month 3 visit, month 6 visit, month 9 visit, month 12 visit / end of study visit.

Eligibility criteria:
inclusion criteria: * signed informed consent . men and women at least 40 years old, with smoking history more than 10 pack-years. * hospitalization for the reason of copd exacerbation (exacerbation defined as acute condition, different from typical fluctuations of general condition and requiring change of therapy). * diagnosis of severe or very severe copd based on final spirometry (performed in a standardized manner using salbutamol 400 mg), or history of diagnosis of severe or very severe copd based on spirometry performed during 6 months before the hospitalization. exclusion criteria: * participation in any interventional study. * concomitant respiratory diseases, i.e. confirmed or suspected malignancy or any other serious condition, including lung tumor, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis. * patient is unable or unwilling to complete questionnaires, unable to understand study procedures, or other reasons which, in the investigator's opinion, could affect study procedures performance.

Keywords: copd spirometry severe and very severe copd copd exacerbations therapy schemes therapy changes
investigation of the effects of classical massage application on individuals with chronic low back pain

Conditions: Low Back Pain

Summary: the aim of this study is to examine the effects of classical massage on pain, spinal mobility, functional and psychological state, and life quality in individuals with chronic low back pain.

low back pain is one of the most common problems in society, experienced by 70-80% of individuals at least once in their lifetime. physical pain can cause serious functional losses that affect independence in daily life. in patients with low back pain, physical endurance decreases because of pain, spasm, decrease in muscle strength and deteriorated posture, and the functional capacity and quality of life of the patient are negatively affected. while most individuals recover spontaneously, 2-8% of them require medical treatment, and the response to conservative treatment is generally good. along with medical treatment, different physiotherapy methods (electro-physical agents, massage, traction, exercises, etc.), which are conservative treatment methods, are also frequently used. it is known that classical physiotherapy modalities (heating agents and exercise approaches) have an important place in the treatment of these patients due to their positive effects on pain, strength, flexibility and functionality. massage is used to systematically manipulate the soft tissues of the body with rhythmic pressure and to provide or maintain health. basically, massage is a simple way to provide pain relief through physical and mental relaxation. it is thought to relieve pain in various ways, including increasing the pain threshold by secreting endorphins and closing the pain gate at the spinal cord level. classical massage is considered rehabilitative and is also used to reduce symptoms associated with medical conditions. it has been reported that classical massage reduces many physical and psychological symptoms in different musculoskeletal problems (neck pain, fibromyalgia, etc.). however, there is a need for placebo-controlled studies in the literature examining the effects of classical massage in individuals with chronic low back pain.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65, * having non-specific low back pain lasting at least 3 months, * individuals willing to participate in the study exclusion criteria: * having different pain syndromes (eg fibromyalgia) * having a history of spinal surgery or invasive examination in the last 6 months, * having a neurological or psychiatric disease * any ongoing related pathology (eg spondylolisthesis, fractures, tumor, osteoporosis or infection), * those with pregnancy status
high-resolution magnetic resonance imaging (mri) scans to look for spread of melanoma to nearby lymph nodes

Conditions: Melanoma

Summary: the study is designed to see if a high-resolution mri scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.

when a melanoma of the skin is diagnosed, there is some chance it can spread to nearby lymph nodes, and from there to other parts of the body. currently, patients with melanoma at low risk for spreading to lymph nodes do not get the lymph nodes assessed except by a physical exam. those at high risk for spreading to lymph nodes get one or more lymph nodes removed surgically to check for melanoma spread. but physical exam alone will often miss small areas of melanoma in lymph nodes; removal of lymph nodes by surgery is painful and can cause complications. neither assessment tool is optimal. this study is designed to see if use of very high-resolution contrast-enhanced mri scans of lymph node areas near the primary melanoma site in the skin can accurately detect small areas of melanoma spread to those lymph nodes. if this turns out to be the case, in the future, mri scans could potentially be an alternative for assessing lymph nodes, compared to physical exams alone or surgical removal of the lymph nodes. in this study, patients with low risk melanoma will receive very high-resolution mri scans of nearby lymph nodes every 6 months for 5 years of follow-up. if the mri looks abnormal, the lymph nodes will be biopsied, and results from the biopsy compared to the results from the mri. patients with high risk melanoma will get a baseline mri of the nearby lymph nodes, and then one or more lymph nodes will be removed (usually by sentinel lymph node biopsy) regardless of the mri results. again, results from the biopsy will be compared to the results from the mri. mri's will still be repeated every 6 months to assess whether lymph nodes not removed at surgery develop any changes. we plan to enroll 200 patients on this study and by the end of the study will have a measure of the sensitivity and specificity of high-resolution mri scans in the detection of melanoma involvement of regional lymph nodes.

Eligibility criteria:
inclusion criteria: * history of invasive cutaneous melanoma stages 1-3 within 2 years of treatment of the melanoma by primary excision * eligible whether or not a sentinel lymph node biopsy or regional lymph node dissection has been performed * adequate renal function (creatinine 2 or less) * life expectancy 2 years of more exclusion criteria: * history of severe claustrophobia precluding mri scans * known hypersensitivity or other contraindication to gadolinium contrast * known presence of metastatic melanoma at sites beyond regional lymph nodes (stage 4)

Keywords: melanoma lymph nodes magnetic resonance imaging screening detection
subjects with t2d or at risk of t2d cohort follow-up

Conditions: Diabetes Mellitus, Type 2

Summary: the main objective of this study is to prospectively follow the subjects included in "descendance" cohort and to describe the occurrence of type 2 diabetes in non-diabetic subjects, which will allow us to iteratively update the "descendance" type 2 diabetes risk prediction model.

high risk families will be prospectively follow in order to better understand the risk of transmission of type 2 diabetes from one generation to another. the cohort will also allow us to collect additional data on diabetic patients. the monitoring of the cohort will take place for at least 10 years with a follow-up of all participants every three years. to detect individuals who develop dysglycemia during the study, a glucose tolerance test (gtt) and hba1c measurement will be conducted.

Eligibility criteria:
inclusion criteria: * subjects have participated in the descendance study * subjets who sign informed consent to participate in the study exclusion criteria: * subjects not enrolled in descendance study * subjects refusing to participate * pregnant or breastfeeding * subjects in emergency situations, under legal protection or unable to provide informed -consent * subjects lost to follow-up or died

Keywords: type 2 diabetes ; risk prediction ; prevention
split-course sbrt for borderline resectable and locally advanced pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: exploratory assessment of the efficacy and safety of gemcitabine-albumin-based paclitaxel chemotherapy combined with sbrt in the treatment of newly diagnosed borderline resectable and locally advanced unresectable pancreatic cancer patients with sequential investigator selection (ic).

the question of how to administer adequate chemotherapy to synchronize sbrt treatment strategy to maximize the benefits of neoadjuvant therapy for improved prognosis of patients with borderline resectable (brpc) and locally advanced (lapc) pancreatic cancer is a challenging and debatable issue. no studies have yet evaluated the efficacy of split-course sbrt as the neoadjuvant chemoradiotherapy regimen. the investigators aimed to study whether neoadjuvant chemotherapy plus split-course sbrt results in better outcomes in brpc and lapc patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old and ≤ 70 years old. * histologically or cytologically confirmed adenocarcinoma of the pancreas. * borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to nccn guidelines * no prior chemotherapy or radiotherapy * ecog performance status of 0 or 1. * without distant metastasis * the maximum diameter of the tumor must not exceed 5 cm * acceptable hematology parameters: a. absolute neutrophil count (anc) ≥1500 cell/mm3 b. platelet count ≥100,000/mm3 c. hemoglobin (hgb)≥9 g/dl * acceptable blood chemistry levels: a. ast/sgot and alt/sgpt≤2.5× upper limit of normal range (uln) b. total bilirubin≤1.5 uln c. alkaline phosphatase≤2.5× uln d. serum albumin\>3 g/dl e. serum creatinine≤1.5 uln * understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted. exclusion criteria: * age \ 70 years old. prior anticancer therapy for pancreatic carcinoma. * presence of or history of metastatic pancreatic adenocarcinoma. * patients who had surgeries, chemotherapy, or other treatments before inclusion. * any other malignancy within 5 years prior to enrollment * history of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients. * peripheral sensory neuropathy grade \> 1 * serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders. * pregnant or breast feeding. * patients enrolled in other clinical trials or incompliant with regular follow-up * unwillingness or inability to comply with study procedures.
itopride in feeding intolerance of critically-ill patients receiving enteral nutrition

Conditions: Critically-ill Patients

Summary: the current study will compare the effectiveness as well as the safety of itopride against metoclopramide as the first line treatment for feeding intolerance in critically ill patients.


Eligibility criteria:
inclusion criteria: * patients aging between 18 and 60 years (of both sexes) who are admitted to the icu and are expected to stay in the icu for not less than 7 days and are prescribed enteral feeding through naso- or oro-gastric tube whose modified nutritional risk in the critically ill (mnutric) score is of more than or equal 5. exclusion criteria: * patients who met the following criteria were excluded: * age less than 18 years or more than 60 years. * previous upper gastrointestinal tract surgery, obstruction, hemorrhage or history of gi disease. * clinically significant hepatic dysfunction. (\>3 times above the upper end of normal range of bilirubin, γ-glutamyl transferase, aspartate transaminase, or lactate dehydrogenase) * regular use of h2 blockers, prokinetic, proton pump inhibitor or anticholinergic agents for previous 4 weeks. * patients with arrhythmia or atrioventricular blocks. * any condition or comorbid disease that might interfere with gastric emptying such as diabetes. * patients with head injuries.
peripheral and central influences on auditory temporal processing & speech perception in older cochlear implantees

Conditions: Hearing Loss; Cochlear Hearing Loss; Hearing Loss, Sensorineural; Aging

Summary: older adults who use cochlear implants to address hearing loss show wide variation in benefit. this research investigates the role of normal aging, the health of peripheral and central auditory pathways, and positioning of the cochlear implant electrode array in contributing to this variability. a range of input types from simple auditory signals to spoken sentences is used to examine these questions.

this research aims to understand age-related temporal processing in older cochlear-implant (ci) users. the overall objective is to disentangle the peripheral and central contributions to age-related temporal processing deficits in this population. the central hypothesis is that age-related speech perception deficits are explained by unique contributions from peripheral and central auditory functions, significantly affecting outcomes in older ci users. the central hypothesis will be tested by determining (1) the extent to which temporal processing of simple signals from single-electrode stimulation can be explained by aging and the peripheral electrode-to-neural interface; (2) the extent to which speech perception can be explained by aging and the peripheral electrode-to-neural interface; (3) the extent and manner in which central auditory compensation overcomes peripheral processing deficits that contribute to age-related performance declines in ci subjects. outcome measures collected in this project include behavioral measures of speech and auditory perception and electrophysiological responses. also collected are questionnaire-based reports of history of ci device use, cognitive screening measures, and imaging-based information regarding electrode placement in the cochlea. better understanding of the locus of age-related temporal processing deficits in this population will aid in developing age-specific guidance regarding ci candidacy, programming, and rehabilitation, thereby improving expected benefit and quality of life.

Eligibility criteria:
for cochlear implant arm: inclusion criteria: * cochlear implant in one or both ears * post-lingual onset of deafness * 1+ years cochlear implant experience * use of cochlear-brand implants * implanted after 2004 exclusion criteria: * use of non-cochlear-brand cochlear implants * no use of oral language * pregnant women are not eligible for the imaging portion of the study. * residual acoustic hearing with unaided thresholds \<90 db hl at more than two standard audiometric frequencies * other known disability or neurological disorder for typical hearing arm: inclusion criteria: * audiometrically normal hearing, near-normal hearing, or mild/moderate hearing loss. exclusion criteria: * severe hearing loss * history of neurological disorders * history of middle-ear disorders
characterization and support for neurodevelopmental disorders associated with congenital heart defects

Conditions: Congenital Heart Defects; Neurodevelopmental Disorder

Summary: the leading cause of birth defects, congenital heart defects (chd) affect 12 million people worldwide and 41,000 newborns/year in europe. it's a major cause of life-long morbidity and mortality, and a crucial public health issue. more than 50% of childs born with critical chd will develop neurodevelopmental disorders (nds), requiring specific care and impairing quality of life. nds corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. they are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). this hidden handicap is the main long-term sequels of chd, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. nds concern not only complex chd, but also simple chd repaired in childhood and considered cured. the origin of tnd associated with chd is largely unknown. to date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality. the catamaran - pediatrics project is designed to detect potential neurodevelopmental delays associated with chd as early as age 3, and to identify individual susceptibility factors involved in the occurrence of nds in chd children.


Eligibility criteria:
inclusion criteria: * child (aged 3 to 11) with critical mcc operated on for heart surgery during the first three months of life * parents and child affiliated with or benefiting from a social security or similar scheme * parents' and child's good understanding of the french language * free, informed and written consent of both parents for themselves and for the child * free, informed and written consent of the child aged 6 and over * biological parents exclusion criteria: * genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion * neurodevelopmental assessment not practicable

Keywords: congenital heart defects neurodevelopmental disorder genetics
the feasibility of an active lifestyle programme in patients recovering from colorectal cancer

Conditions: Colorectal Cancer

Summary: long-term maintenance of physical activity behaviour change post-intervention remains challenging. this study is investigating the feasibility of a behaviour change intervention based on self-determination theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.

this study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. participants were allocated to an active lifestyle programme (alp) or the standard (sc) care group. alp was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. sc was encouraged to continue with their usual lifestyle. the intervention was informed by self-determination theory. the supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. exercise included aerobic and resistance exercises. the behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants. participants were followed-up at 6 months. there was no contact with participants during the post-intervention and follow-up period.

Eligibility criteria:
inclusion criteria: * a histologically confirmed diagnosis of colorectal cancer with dukes stages a-c * completed cancer treatment within the last 24 months, * be able to understand spoken and written english * score of 80 or more on the karnofsky performance status scale exclusion criteria: * already meeting general pa guidelines of 150 min of moderate pa or 75 min of vigorous intensity pa per week, * recent myocardial infarction * uncontrolled hypertension * a pacemaker * or unstable angina.