Kornimate/medical-research-clean huggingface dataset:
mid-to long-term outcomes in chronic myeloid leukemia (cml) patients with complete cytogenetic response after imatinib as first line therapy

Conditions: Chronic Myeloid Leukemia

Summary: rationale: at present, virtually no evidence exists regarding mid to long-term patient-reported health outcomes (e.g., health related quality of life-hrqol) of cml patients treated with imatinib. purpose: the results of this research will provide preliminary evidence-based data on an number of issues from the patients' perspective, including adherence to therapy issues.

objectives: primary: to investigate a number of mid to long-term hrqol issues in chronic myeloid leukemia (cml) patients with complete cytogenetic response treated with imatinib as first line therapy. secondary evaluation of: * psychological wellbeing. * fatigue. * adherence to therapy issues. * symptom burden. * possible association between social-demographic and clinical variables with patient reported health outcomes. outline:this is a multicenter study. sample size: sample size estimation has not been performed considering the nature of the study and the lack of preliminary data to hypothesize the number of possible eligible patients in each center. duration of the study: the recruitment period is estimated in approximately 6 to 12 months.

Eligibility criteria:
inclusion criteria: * age 18 years. * cml patients meeting the following criteria: * started im therapy in the early chronic phase (ecp). * have been undergoing treatment with im, as first line therapy, for at least three years regardless of the current prescribed dose of im. * in complete cytogenetic response (ccgr) and no clinical evidence of disease progression to accelerated phase (ap) or blast crisis (bc). * able to read and write italian. * freedom from psychiatric conditions that may confound hrqol evaluation. * informed consent provided. exclusion criteria: * cml patients who were initially diagnosed in the ap or bc or those who started therapy with im in the late chronic phase (lcp). * having received any kind of treatment prior to im therapy (except for hydroxyurea and/or anagrelide). * patients with a new primary malignancy.

Keywords: health outcomes research cml
clinical trial of yh25448(lazertinib) as the first-line treatment in patients with egfr mutation positive locally advanced or metastatic nsclc (laser301)

Conditions: Non-Small Cell Lung Cancer

Summary: this phase iii study will be conducted to evaluate the efficacy and safety of yh25448 as first-line treatment in locally advanced or metastatic non-small cell lung cancer (nsclc) patients with egfr mutations

yh25448 is an oral, highly potent, mutant-selective and irreversible egfr tyrosine-kinase inhibitors (tkis) that targets both the t790m mutation and activating egfr mutations while sparing wild type egfr. this is a phase iii, randomized, double-blind study evaluating the efficacy and safety of yh25448 (240 mg orally, once daily) versus gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic nsclc that is known to be egfr sensitizing mutation (egfrm) positive, treatment-naïve and eligible for first-line treatment with an egfr-tki.

Eligibility criteria:
inclusion criteria: * pathologically confirmed adenocarcinoma of the lung * locally advanced or metastatic nsclc, not amenable to curative surgery or radiotherapy * at least 1 of the 2 common egfr mutations known to be associated with egfr tki sensitivity (ex19del or l858r), either alone or in combination with other egfr mutations * treatment-naïve for locally advanced or metastatic nsclc * who performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization * at least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study screening period exclusion criteria: * symptomatic and unstable brain metastases * leptomeningeal metastases * symptomatic spinal cord compression * history of interstitial lung disease (ild), drug-induced ild, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ild * any medical conditions requiring chronic continuous oxygen therapy * history of any malignancy other than the disease under study within 3 years before randomization * any cardiovascular disease as follows: * history of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment * history of myocardial infarction or unstable angina within 24 weeks of randomization

Keywords: locally advanced egfr sensitizing mutation metastatic egfr sensitizing mutation egfr tki ex19del l858r first-line yh25448 advanced non-small cell lung cancer adenocarcinoma of lung non-squamous carcinoma of lung phase iii lazertinib
robotic-assisted exercise training in heart failure with reduced ejection fraction

Conditions: Heart Failure, Systolic

Summary: this study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional new york heart association class iii-iv by using an externally physically-supported exosuit movement therapy. this soft, wearable robot (myosuit) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. the feasibility, tolerance and safety of a myosuit assisted training was shown in a feasibility trial. in the efficacy trial, patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed.


Eligibility criteria:
inclusion criteria: * \>17 years old * written informed consent * chronic end-stage systolic heart failure without ventricular assist device, lvef ≤ 45% * clinically stable for at least 6 weeks * ability to mobilize into standing and walking of at least 10 meters with or without rollator * ability to get up from a chair without rotating the upper body \>45° sagittally exclusion criteria: * addictions or other illnesses that impact the ability to understand the nature, scope and * consequences of the trial * lack of knowledge of german to fully understand study information * pregnancy, pre-menopausal women * contraindications of cardiopulmonary exercising * bmi \> 35 kg/m², waist size \> 135 cm. * height \ 195 cm * weight\ 110 kg * functional reach test \<15,24 cm * flexion contracture in the knee/hip joint \>10° * chronic colonization or active infection with multi-resistant pathogens

Keywords: exercise training robotic training
crossed education in relation to muscle mass in patients operated of clavicular fracture

Conditions: Clavicle Fracture

Summary: the immobilization process after an operation or injury in the upper extremity causes a loss of muscle mass and strength of 0.2% and 1.3% per day, respectively. currently, the use of cross-education, which is unilateral training in the uninjured limb, during the immobilization period, is expanding, demonstrating a magnitude of strength gain in the immobilized limb from 8% to 77% of the mean of strength of the trained limb. despite the evidenced benefits of cross-education in unilateral injuries such as distal radius fracture, anterior cruciate ligament injury, and knee replacement, very little is known about this effect in shoulder immobilization after clavicle fracture.

objective: to determine the effectiveness of cross-education training through eccentric strength exercises compared to concentric-eccentric after the 6-week immobilization period and after 12 postoperative weeks in relation to muscle mass, strength, and functionality in patients operated of clavicular fracture. hypothesis: cross-education training through eccentric strength exercises produces greater effects compared to concentric-eccentric training during the immobilization period and after 12 postoperative weeks, in relation to muscle mass, strength and functionality in patients operated for clavicle fracture. methodology: an experimental, randomized, single-blind study will be carried out, in which 39 men from 18 to 40 years of age will be recruited, who are awaiting surgery for clavicle fracture. they will be divided into three groups: control group (standard kinesic therapy 12 weeks after immobilization of 6 weeks, n=13), concentric-eccentric group (concentric-eccentric strength training in the uninjured limb during the 6-week immobilization period + standard kinesics therapy, n=13) and group eccentric (eccentric strength training on the uninjured limb during the 6-week immobilization period + standard kinesics therapy, n=13). expected results: it is expected to observe a gain in muscle mass and strength in the trained limb and a maintenance/gain of muscle mass and strength in the groups that perform cross-training during the immobilization period, presenting the greatest benefit in the group that performs training eccentric force.

Eligibility criteria:
inclusion criteria: * men from 18 to 40 years old, diagnosed with radiographically verified clavicle fracture and awaiting surgical procedure. they have a body mass index of not less than 18.5 and not more than 29.9 kg/m2 and sign an informed consent. exclusion criteria: * patients with previous injuries, pathological fracture or polytrauma * patients who report pain, a history of rotator cuff tear or surgery in the non-injured upper extremity. * patients with uncontrolled cardiovascular diseases. * any history of neurological problems in the upper extremities. * use of nutritional supplementation (leucine, glutamine, casein, whey-protein, fatty acids and creatine) and/or hormonal replacement therapy.

Keywords: muscle mass cross education eccentric training
rosa total knee investigational testing authorization study

Conditions: Knee Pain; Chronic Osteoarthritis; Avascular Necrosis of Femoral Condyle; Moderate Varus, Valgus or Flexion Deformities; Rheumatoid Arthritis

Summary: this is a prospective, single-center clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. this clinical study will include persona total knee components using the rosa total knee robotic system or conventional instrumentation.

the primary objective of this study is to collect and compare clinical outcomes and surgical data using the rosa total knee robotic instrumentation and conventional instrumentation in primary total knee arthroplasty. the assessments will include: planned vs actual component positioning; workflow efficiency; patient safety based on incidence and frequency of adverse events; clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.

Eligibility criteria:
inclusion criteria: 1. patient is a minimum of 18 years of age 2. pre-op component positioning and sizing plan prior to surgery 3. independent of study participation, patient is a candidate for primary tka using the commercially available persona knee components implanted in accordance with product labeling 4. patient has participated in this study-related informed consent process 5. patient is willing and able to provide written informed consent by signing and dating the irb or ec approved informed consent form 6. patient is willing and able to complete scheduled study procedures and follow-up evaluations exclusion criteria: 1. patient is currently participating in any other surgical intervention studies or pain management studies 2. patient has underwent contralateral uka or tka within the last 18 months 3. hip pathology with significant bone loss (e.g. avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or the acetabulum) 4. hip pathology severely limiting range of motion (e.g. arthrodesis, severe contracture, chronic severe dislocation) 5. patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) 6. patient has previously received partial or total knee arthroplasty for the ipsilateral knee
cognitive remediation and sheltered employment in schizophrenia

Conditions: Chronic Schizophrenia

Summary: this study, driven on schizophrenic patients, is aimed at : 1. measuring the efficiency of the cognitive remediation program recos (cognitive remediation in schizophrenia) on the capacity of the patients suffering from schizophrenia to improve the integration in sheltered employment (esat and ea). 2. comparing the efficiency of the program of cognitive remediation recos (recos arm) to the one of an usual program of coverage/care (tau arm = treatment as usual) on integration in sheltered employment of patients suffering from schizophrenia. 3. realizing a comparative analysis, in both arms, of : 1. the number of working hours achieved in sheltered environment during the 6 months following the two programs (reported to the working time planned by the contract of employment) 2. the duration of such employments in sheltered areas. 4. estimating the impact of recos on the neuropsychological variables, the symptomatology, the consciousness of the disorders(insight), the quality of life and the social autonomy before the treatment (month m0), at the end of the treatment (month m3), and 6 months later (month m9), and looking for a correlation between the improvement of these parameters and sheltered employment. 5. estimating the impact of cognitive remediation on integration in sheltered employment.


Eligibility criteria:
inclusion criteria: * age from 18 to 50 years. * schizophrenia according to the criteria of the dsm-iv-tr. * project of entry to esat or to ea in the 6 weeks which follow. * iq \> 70 (f-nart). * stable symptomatology during the month preceding the inclusion. * psychotropic treatment unchanged during the month preceding the inclusion (change no more than 25 % posology). * overdrawn performances in at least one of the 6 functions estimated by the kit of neuropsychological tests. * french mother tongue. * informed and signed consent by the patient. * agreement of the guardian (for protected adults). * membership in a national insurance scheme. exclusion criteria: * dependence and recent abuses of cannabis (\> 2 / week) or in any other substance (according to the criteria of the dsm-iv-tr), except tobacco. * neurological disorders of vascular, infectious or neurodegenerative origin; dyschromatopsie. * taking of medicine with somatic tropism having a cerebral or psychic impact (eg: corticoids). * simultaneous participation to any other program of remediation targeting the neurocognitive deficits. * resistance to neuroleptic. * reading and writing not acquired.

Keywords: schizophrenia cognitive remediation working abilities and social functioning
lupus nephritis: role of environmental and occupational exposures

Conditions: Lupus Nephritis

Summary: the purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (sle) or renal disease (e.g., silica dust, smoking). we will also assess potential gene environment interactions. we will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. we will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the carolina lupus study. one hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the glomerular disease collaborative network (gdcn) nephropathology database and participating nephrologists at the medical university of south carolina, duke university medical center and the east carolina medical school.

the purpose of this study is to examine hormonal and environmental risk factors (and possible gene-environmental interactions) involved in the etiology of lupus nephritis. our study will focus on exposures to occupational and environmental agents that have been linked to the development of systemic lupus erythematosus (sle) or renal disease (e.g., silica dust, smoking). we will also assess potential gene environment interactions. we will examine these exposures in 100 patients with renal biopsy with documented proliferative or membraneous nephritis. we will compare exposures in the lupus nephritis patients to lupus patients who do not have nephritis and to normal controls who have participated in the carolina lupus study. one hundred lupus nephritis patients (age 18 years or older, of both genders and all races) will be identified through the glomerular disease collaborative network (gdcn) nephropathology database and participating nephrologists at the medical university of south carolina, duke university medical center and the east carolina medical school.

Eligibility criteria:
* inclusion criteria: have renal biopsy proven lupus nephritis (with the biopsy-based diagnosis date no earlier than january 1, 1995). reside within designated counties of eastern north carolina and south carolina.

Keywords: case-control hydrocarbons metals silica tobacco smoke lupus nephritis environmental exposures occupational exposures
manage my pain at chronic pain clinics

Conditions: Chronic Pain

Summary: the overall objective of this early adoption project is to gather evidence for how managing my pain program (mmp), a novel digital pain management application can enable better care at home for chronic pain sufferers in the province of ontario, canada across 4 sites in urban, community, and rural settings

chronic pain imposes a large burden on individuals and society. a patient-centric digital chronic pain management application, managing my pain program (mmp) that incorporates validated questionnaires can be used to enhance communication between providers and patients and promote self-management to evaluate the extent of patient engagement with the app when used in clinical settings. the main objectives for this project is to evaluate the engagement in patients using mmp, and to assess improvements in clinical outcomes directly relevant for pain management, as measured by clinically-validated tools.

Eligibility criteria:
inclusion criteria: * new patients with chronic pain conditions referred to participating sites with pain programs to adopt the mmp tool into clinical practice. exclusion criteria: * patients declining to consent for the study * patients withdrawing from the study at a later time after consenting

Keywords: pain psychology patient oriented research quality of life digital health chronic pain pain app virtual care mhealth pain management chronic disease management remote monitoring
impact of the cionic neural sleeve on mobility in multiple sclerosis

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Summary: the purpose of this research is to support the clinical value of the cionic neural sleeve for individuals diagnosed with multiple sclerosis (ms).

the randomized within-participants crossover study aims to demonstrate the clinical impact of the cionic neural sleeve for individuals diagnosed with ms. physical measurements, performance-based tests, and questionnaire responses will be recorded. these include physical activity recorded by an actigraph; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of ms. all participants will be assigned a hip-worn actigraph activity monitor, a cionic neural sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. the actigraph will be worn for the duration of the 12-week walking intervention, while the cionic neural sleeve will be worn for 6 weeks of the study. participants will be randomized to one of two groups: a or b. group a will wear the actigraph and receive stimulation assisted walking from the neural sleeve (intervention), while group b will only wear the actigraph while walking. after 6 weeks, participants in each group will cross over to the other group.

Eligibility criteria:
inclusion criteria: * persons with relapsing-remitting or progressive forms of ms between the ages of 22 and 75 * ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device * adequate cognitive and communicative function as assessed via telephone interview for cognitive status (tics) to identify persons with dementia * able to tolerate the neural sleeve device for up to 8 hours per day * t25fwt time between 8 and 45 seconds * no recent change in medication or recent exacerbation of symptoms over the last 60 days * patient-determined disease steps score between 3 and 5 or edss score between 4 and 6.5 exclusion criteria: * lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation * absent sensation in the impacted or more impacted leg * inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation * inability to ambulate with the sleeve in place of an ankle foot orthosis (afo)/knee ankle foot orthosis (kafo) if utilized * history of falls greater than once a week * no use of fes devices in the past year * demand-type cardiac pacemaker or defibrillator * malignant tumor in the impacted or more impacted leg * existing thrombosis in the impacted or more impacted leg * fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
increasing colorectal cancer screening among filipino americans

Conditions: Colorectal Cancer

Summary: develop and evaluate in a randomized trial an educational small group intervention to increase colorectal cancer screening among filipino americans.

the purpose of this research study is to increase colorectal cancer (crc) screening among older filipino americans, specifically the use of fecal occult blood tests (fobts). we will design a culturally specific intervention, an educational small group discussion with a filipino health professional. the effect of the intervention will be tested with 620 filipino americans. subjects will be recruited at community-based organizations and churches and invited to join a 1 1/2 hour discussion of health issues with their partner and some of their friends. a third of the subjects will discuss exercise (control group), another third will discuss crc and receive an fobt kit, and the remaining third will discuss crc and will not receive an fobt kit. three months after the group session, subjects in the crc (intervention) groups will receive a letter reminding them to get screened. all subjects will be interviewed before and 6 months after the group sessions to assess crc screening levels in the three groups. self-reported crc screening will be verified by a review of their medical records.

Eligibility criteria:
inclusion criteria: * being: a filipino american, * member of or affiliated with participating community agencies, between the ages of 50 and 70, * not up-to-date with colorectal cancer screening at baseline exclusion criteria: * being younger than 50 or older than 70 years, * not being a member or not affiliated with participating community agencies, * not being filipino american or up-to-date with colorectal cancer screening at baseline

Keywords: colorectal cancer screening fecal occult blood test endoscopies filipino american immigrants community based organizations and churches