Kornimate/medical-research-clean huggingface dataset:
innovative models in the rehabilitation of the elderly with hip fractures through technological innovation

Conditions: Hip Fractures; Frail Elderly; Robotic Rehabilitation

Summary: the final goals of the present study is to propose a new approach in the hip fracture rehabilitation in elderly subjects, focused on the use of robotic device and to check the results not only at the end of the treatment but also in the long term, foreseeing 3 follow-up.

balance and deficit in walking are some of the main characteristics of aging and are considered among the risk factors for falls. falls are a risk factor for future falls and are associated with other adverse health outcomes such as fear of falling or fractures. in particular, hip fracture in aged patients is an important health problem. in fact, one in three patients dies within the first year after injury, while survivors have poor quality of life for this reason, the development of prevention tools and innovative strategies in the rehabilitation field should be one of the main objectives in the treatment of the diseases afflicting the elderly, such as hip fractures. effective interventions to promote hip recovery post hip fracture are characterized by intensive and repetitive movements. one treatment approach to increase number of steps during rehabilitation sessions and to improve the balance and the endurance of the patients is the use of robotic systems. this study is a randomized controlled trial. a total of 195 patients with hip fractures will be recruited and randomly divided into three groups, to receive a traditional rehabilitation program or a robotic rehabilitation in addition to the traditional therapy. assessments will be performed at baseline, at the end of treatment and 6 months, 1 year and 2 years from the end of the treatment. for the study, post-hospitalization subjects will be taken into consideration, after four weeks from the hospitalization. a 20 treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. the control group will perform traditional therapy sessions lasting 50 minutes. the technological intervention group will carry out 30 minutes of traditional therapy and 20 minutes of treatment with a robotic system.

Eligibility criteria:
inclusion criteria: * capacity to consent * traumatic event within 60 days * romberg test: negative * functional ambulation category (fac) score ≤ 2 * ranking scale score ≤ 3; exclusion criteria: * past history of syncopal episodes * presence of non-pharmacologically compensated behavioral syndromes * presence of pain that prevents walking or standing * presence of neurological pathologies that compromise balance (multiple sclerosis, parkinson's disease, stroke, ataxias, poliomyelitis) * spinal stenosis * radiculopathy * neuropathies lower limbs * disabling disabilities that impair walking (eg congenital malformations of the foot) * heterometry \> 2 cm * clinical dementia rating (cdr) score ≥ 3 * severe systemic diseases with life expectancy \< 1 year * patients unable to follow up.

Keywords: hip fracture rehabilitation robotics
gentlecath™ air intermittent catheter smartwatch real life pilot study

Conditions: Neurogenic Bladder

Summary: as part of the ongoing clinical evaluation and post market clinical follow up (pmcf) activities it was determined that a pilot study should be conducted to look at how real life data such as various physiological measurements can be collected via a smart-watch during intermittent self-catheterisation whilst also collecting real life feedback from users on comfort as measured by levels of possible discomfort and on levels of anxiety which may be associated with intermittent catheterisation over a period of time. adherence to catheter regimen and proper emptying of the bladder is of clinical relevance for clean intermittent catheterisation. a daily fluid diary is included in this pilot study together with the use of the microphone of the apple™ smart watch to investigate the feasibility of tracking input and output of fluids. the user acceptance of the daily fluid diary offered via the iphone app and the feasibility of the microphone to capture bladder emptying or voiding are to be tested within this pilot.


Eligibility criteria:
inclusion criteria: * • females aged 18 years old and above who require intermittent bladder drainage * idiopathic and neurogenic subjects * be willing and able to provide electronic informed consent * be willing and able to wear a polar h10 chest-strap * must be willing and able to use the smart technology provided e.g. smart phone with software application and/or smart watch to answer the required questions * currently use intermittent catheters * have used intermittent catheters for more than 6 months * subjects who perform intermittent catheterisation at least twice per day * speak, read and write in english exclusion criteria: * • subjects who require intermittent catheterisation to administer irrigation or instillation. * short term voiding difficulties following botox injections * currently participating in another clinical trial or has participated in a clinical study in the previous month * current users of the gentlecath™ air intermittent catheter * exhibiting any other medical condition which, according to the investigator, justifies the subject's exclusion from the study, for example- medical conditions that affect heart rate, anxiety disorders, uncontrolled diabetes, hyperthyroidism, psychological disorders, and other causes of blunted autonomic response. * subjects with a known alcohol dependency and/or recreational drug use * current symptomatic urinary tract infection (uti) or diagnosed uti in the previous 2 weeks * known sensitivity to the catheter device components or the apple™ watch or polar™ h10 chest straps * pregnancy or breast feeding * subjects, in the opinion of the investigator, unable to carry out the study procedures or other factors e.g. planned surgery which may prevent them from completing the study.

Keywords: neurogenic bladder intermittent self-catherterisation
atmeg (atorvastatin and omega-3 combination) and carotid atherosclerosis in patients with type 2 diabetes and combined dyslipidemia

Conditions: Dyslipidemias; Atherosclerosis; Diabetes Mellitus, Type 2

Summary: this is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in korean t2dm patients with asymptomatic atherosclerosis.

in patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3d carotid ultrasound.

Eligibility criteria:
inclusion criteria: * type 2 diabetes under treatment with hba1c 6.0-10.0% at screening visit * male or female of 20 years or over * mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dl, hdl-cholesterol ≤50 mg/dl, ldl-cholesterol ≥100 mg/dl * moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin xl 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg * identified carotid artery plaque: carotid intima-media thickness (cimt) ≥ 1.0 mm * asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction * creatinine ≤1.8 mg/dl exclusion criteria: * dyslipidemia which requires other therapy: triglyceride ≥500 mg/dl or ldl-cholesterol ≥190 mg/dl * uncontrolled hypertension: sbp \>180 mmhg or dbp \>110 mmhg * severe renal dysfunction: egfr \<30 ml/min/1.73m2 * ast/alt \>120/120 or chronic liver disease * pregnant or childbearing woman who does not have enough contraception * changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months * usage of dyslipidemia therapy other than statin
safety study for short-course accelerated, hypofractionated partial breast radiotherapy (apbi) in women with early stage breast cancer using the contura mlb

Conditions: Breast Cancer

Summary: to determine local disease control (recurrence) with shorter course of apbi delivered with a breast brachytherapy applicator.


Eligibility criteria:
inclusion criteria: * life expectancy \> 10 years * lumpectomy with clear margins (negative per nsabp criteria) * dcis and/or invasive carcinoma * if invasive, nodes must be negative * t stage is tis, t1 or t2\<=3 cm max diameter * er(+) or er(-)/pr(+) exclusion criteria: * pregnant or breast feeding * active collagen-vascular disease * paget's disease of the breast * prior history of breast cancer * prior breast or thoracic radiotherapy * multicentric carcinoma * synchronous bilateral breast cancer * surgical margins that cannot be assessed or that are positive * t stage is t2\>3 cm or greater * er(-)/pr(-)

Keywords: breast cancer apbi brachytherapy contura
spatially resolved ibd: spatial transcriptomics of inflammatory bowel disease (ibd)

Conditions: Patients With Histologically Confirmed CD Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease; Patients With Histologically Confirmed UC Undergoing Intestinal Resection According to Standard of Care Due to Complicating Disease

Summary: the goal of this retrospective observational study is to obtain the spatial resolution of the entire intestinal fibrotic process through the technology stomics stereoseq. for this study we will use surgical specimens from 8 uc e 8 cd previously collected for the already approved project, ibd biobank, and stored at -80° c.

this is a monocentric observational study in which we will use the biological material from surgery carried out for normal clinical practice, and already stored at -80°c. this project has as purpose: 1. to unravel the changes in the intestine leading to complications in cd and uc patients. in particular, we aim to identify the cell populations, their spatial organization, interactions, and specific transcriptional shifts, leading the progression from healthy tissue to inflamed and from inflamed to fibrotic tissue. we will be interested in producing a profile of spatial transcriptomics of all areas of the surgical specimen. 2. to compare the spatial organization and differential gene expression of tissue

Eligibility criteria:
inclusion criteria: * adult patient (age ≥18 years), both male and female patients with histologically confirmed cd and uc undergoing intestinal resection according to standard of care due to complicating disease, regardless of their current or past medical treatment; * patients that have signed the ibd biobank informed consent and consented to the use of their own biological material in future study or pertaining to the same field of investigation. exclusion criteria: * - patients with unconfirmed both uc and cd diagnoses; * patients with superimposed dysplasia or cancer diagnosis and resections for which post- operative endoscopic assessment of recurrence is not feasible; * patients who have not signed the ibd biobank informed consent.
safety and efficacy of zemplar capsule in reducing serum ipth levels in chronic kidney disease subjects (three times weekly)

Conditions: Renal Insufficiency, Chronic

Summary: the objective of this study is to determine whether paricalcitol is safe and effective compared to placebo in reducing elevated serum pth levels in patients with chronic kidney disease.


Eligibility criteria:
inclusion criteria: * under care of physician at least 2 months (for ckd) * not on active vitamin d therapy for at least 4 weeks prior * if female: * not of childbearing potential, or * practicing birth control * not breastfeeding * if taking phosphate binders, on a stable regimen at least 4 weeks prior * for entry into pretreatment phase: * ipth at least 120 pg/ml * gfr of 15-60 ml/min and no dialysis expected for at least 6 months * for entry into treatment phase: * average of 2 consecutive ipth values of at least 150 pg/ml, taken at least 1 day apart (all values not less than 120 pg/ml * 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dl * 2 consecutive serum phosphorus levels of not more than 5.2 mg/ml exclusion criteria: * history of allergic reaction or sensitivity to similar drugs * acute renal failure within 12 weeks of study * chronic gastrointestinal disease * spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones * taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study * current malignancy, or clinically significant liver disease * active granulomatous disease (tb, sarcoidosis, etc.) * history of drug or alcohol abuse within 6 mos. prior * evidence of poor compliance with diet or medication * received any investigational drug or participated in any device trial within 30 days prior * taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy) * on glucocorticoids for a period of more than 14 days within the last 6 months * hiv positive
supporting patient care with electronic resources in the united states

Conditions: Rheumatoid Arthritis

Summary: this proof-of-concept randomized trial evaluates the effectiveness of using an online decision aid (us-answer-2) in the decision-making to start or switch biologic therapy in us patients with rheumatoid arthritis.

the proposed project aims to improve the process of making evidence-informed treatment decisions by patients with rheumatoid arthritis (ra) and ultimately empower patient self-management. current ra treatment emphasizes: 1) the need for early and aggressive treatment, and 2) the use of a treat-to-target approach. however, patients often struggle with treatment decisions, especially when the options have both benefits and risks. to address this challenge, investigators based at arthritis research canada have previously developed an online decision aid called answer-2 (animated, self-serve, web-based, research tool: version 2) for ra patients who are considering a biologic, and this tool has been recently adapted for the us healthcare setting (called us-answer-2). objectives: 1) to evaluate the effectiveness of us-answer-2 in reducing patients' decisional conflict. 2) to assess the extent to which us-answer-2 improves patients' knowledge about ra medications and confidence in managing their health. 3) to examine the experiences of patients and rheumatologists in using us-answer-2. the investigators will conduct a proof-of-concept randomized controlled trial with 80 patients with ra. eligible individuals are those: 1) with a diagnosis of ra from a rheumatologist, 2) whose rheumatologists have recommended initiating a biologic or switching to another biologic, and 3) who have internet access and email. the intervention group will receive simple instructions to access the us-answer-2 decision aid and complete the program on their own within two days. at the end of the session, a one-page summary will be produced to help them discuss their questions, concerns, and preferred choices with their health care providers. the control group will receive a standard online medication guide, reflective of usual practice. participants will complete the decisional conflict scale (primary outcome) before and after the intervention (us-answer-2 or standard online medication guide). the following secondary outcome measures will be collected at baseline, month 1, and month 2: 1) medication education impact questionnaire, and 2) partners in health scale. in addition, the use of healthcare resources will be collected at baseline and month 2, and the use of biologics will be collected at month 6. all participants and their rheumatologists will be invited to participate in a qualitative interview about their experience with the patient decision aid.

Eligibility criteria:
inclusion criteria: * the inclusion criteria are as follows: 1. with a diagnosis of ra from a rheumatologist 2. whose rheumatologists have recommended initiating a biologic or switching to another biologic 3. who have internet access and email. exclusion criteria: * patients who do not meet the inclusion criteria.

Keywords: rheumatoid arthritis decision aids biologics
the comparison of cataract lasers using the optimedica catalys laser and the alcon lensx laser.

Conditions: Nuclear Sclerosis of the Lens; Posterior Subcapsular Cataract; Cortical Cataract

Summary: this study compares two fda approved cataract lasers.

the purpose of this study is to systematically evaluate the performance of two commercially available and fda cleared femtosecond laser systems in patients undergoing femtosecond laser-assisted cataract surgery. objective data on the repeatability and accuracy of the studied parameters will be gathered and reported as endpoints of the study. the two systems studied are the catalys™ precision laser system (optimedica, ca, usa) and the lensx® laser system (alcon laboratories, inc., fort worth, tx). published data have suggested that the femtosecond laser is a useful tool for cataract surgery. this study is to determine whether differences or similarities exist in specific treatment parameters achieved with two fda cleared and commercially available femtosecond laser cataract surgery platforms

Eligibility criteria:
inclusion criteria: * have grade 2 to 4 nuclear sclerotic and or cortical or posterior subcapsular cataracts with visual impairment. * pupillary dilation of at least 6.0 mm * axial length between 21 mm to 26 mm * age ≥ 22 years of either gender * require laser assisted corneal incisions, capsulotomy and nucleus segmentation * understand and sign a written informed consent form * be able to comply with the treatment and follow-up schedule exclusion criteria: * enrolment in another drug or device study within the prior 3 months * history of ocular trauma * acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.) * uncontrolled systemic or ocular disease * corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies, severe corneal opacities, significant corneal edema, etc) * diminished aqueous clarity that obscures oct imaging of the anterior lens capsule * corneal ring and/or inlay implant(s) * pseudoexfoliation * known steroid iop responder or ocular hypertension iop \>25 mmhg by tonometry * retinal detachment within the last 6 months * anterior chamber depth less than 2.5 mm
study of the anatomical and functional recovery and quality of life of patients undergoing corneal transplantation

Conditions: Cornea Transplant

Summary: evaluate the well-being of patients and clinicl outcomes of the cornea after transplantation

the study aims to evaluate patients affected by corneal diseases who will undergo corneal transplantation. the evaluation will be carried out pre and post transplantation to evaluate the clinical outcome of the patients and the quality of life and functional anatomical recovery.

Eligibility criteria:
inclusion criteria: * be eighteen years old * diagnosis of corneal disease with prescription of surgical treatment of corneal transplantation * sign the informed consent exclusion criteria: * no exclusion criteria
neurocognition in patients with multiple brain metastases treated with radiosurgery

Conditions: Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm

Summary: this phase ii trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (srs) or stereotactic body radiation therapy (sbrt). stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. this method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. assessment of neurocognitive function may help show that srs preserves neurological function in patients with multiple brain metastases better than sbrt.

primary objectives: i. assessment of neurocognitive function at months 4. secondary objectives: i. assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests. ii. assessment of symptom burden, as measured by the m.d. anderson symptom inventory- brain tumor module (mdasi-bt). iii. assessment of quality adjusted survival and health outcomes using the european quality of life five dimension five level scale questionnaire (eq-5d-5l). iv. assessment of local control, in brain control. v. assessment of progression free survival (pfs), and overall survival (os). vi. assessment of side effects and toxicities. outline: patients undergo srs on day 1 or sbrt for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing srs or sbrt. after completion of study, patients are followed up at 2, 4, 6, 8, 10, and 12 months.

Eligibility criteria:
inclusion criteria: * pathologically proven solid tumor malignancy (except for small cell lung cancer \[sclc\], germ cell tumor) * karnofsky performance status \>= 60 * 1 to 10 brain metastases (mets) (no more than two lesions and/or cavities \>= 3 cm in maximum diameter) * maximum diameter of brain metastasis or resection cavity is 6 cm * serum creatinine =\ = 30 ml/min * patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol * women of childbearing potential must have a negative beta-human chorionic gonadotropin (hcg) pregnancy test documented within 21 days prior to registration * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose * patient able to provide his/her own written informed consent and speak english exclusion criteria: * patient with diagnosis of glioma, or other world health organization (who) grade ii - iv primary brain tumor * prior brain surgery =\< 14 days prior to enrollment * planned chemotherapy during radiosurgery * leptomeningeal metastases * intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months * pregnant women