Kornimate/medical-research-clean huggingface dataset:
building a renewed image after head & neck cancer treatment

Conditions: Head and Neck Squamous Cell Carcinoma; Body Image Disturbance

Summary: this study will evaluate whether a time-limited cognitive behavioral therapy (cbt) intervention in the post-treatment time period can address body image disturbance (bid) in patients with surgically-treated head and neck cancer (hnc), thereby improving bid and quality of life (qol).

the investigators will complete a single-arm, phase ii pilot study of time-limited cbt on bid in patients with surgically-treated hnc. reliable, validated patient-reported outcome (pro) measures of bid will be collected before, 1 month and 3 months after the cbt intervention to provide preliminary data on the effectiveness of cbt for bid in patients with surgically-treated hnc, addressing this critical knowledge gap. it is expected that time-limited cbt implemented in the post-treatment period will decrease bid and improve qol in affected patients.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of squamous cell carcinoma of the upper aerodigestive tract (oral cavity, oropharynx, hypopharynx, larynx) or cutaneous malignancy of the head and neck (e.g. squamous cell, basal cell, melanoma, etc) * age \> 18 * american joint committee on cancer (ajcc) stages i-iv * curative intent therapy with surgery with or without adjuvant therapy * body image scale (bis) score \> 5 up to 1 year post-treatment exclusion criteria: * inability to speak english * known distant metastatic disease * inability or unwillingness of subject or legal guardian/representative to give informed consent

Keywords: head and neck cancer body image disturbance cognitive behavioral therapy survivorship
physical activity and leisure-time study (pals)

Conditions: Physical Activity; Weight

Summary: physical inactivity is a major public health problem and a primary contributing factor to the obesity epidemic. while most americans do not meet the physical activity (pa) guidelines (30 min/day, 5 day/wk), they do report watching several hours of tv each day, and frequently site "lack of time" as a barrier for engaging in pa. the physical activity and leisure-time study examines an approach convert sedentary tv watching into active tv watching time by having adults step in place during commercials (tv commercial stepping).

this randomized controlled trial will examine the effects of a pa prescription of tv commercial stepping for at least 90 min/day of tv programming, with that of walking at least 30 min/day (30 min walk) on daily step counts, tv viewing, and diet during a 24 week pa intervention. sedentary, overweight or obese, adults will be randomly assigned to either the tv commercial stepping, or 30 min walk group during a 24-week behavioral pa intervention. both groups will attend 8 sessions, but receive different pa goals. pa, tv watching time, diet, and anthropometric data will be collected at 0, 12, and 24 weeks. it is hypothesized that the tv commercial stepping condition will, show an equal increase in pa at 12 and 24 weeks as compared to the 30-min walk condition. neither group is hypothesized to demonstrate changes in tv viewing time, dietary intake, or weight.

Eligibility criteria:
inclusion criteria: * 25 to 65 years of age * bmi between 25 and 45 kg/m2 * watch ≥14 hours per week of tv * ability to follow instructions and record data * ability to walk 1/4 mile without stopping exclusion criteria: * history of myocardial infraction, angina, stroke, heart failure, or uncontrolled cardiac arrhythmias * a resting blood pressure greater than 180 mm hg systolic and/or 100 mm hg diastolic * other physical or medical limitations for engaging in physical activity * no television in the home * baseline physical activity level exceeding 7,499 steps per day as determined by the omron pedometer * currently participating in a program to increase pa * intended to move outside the east tennessee area within the time frame of the intervention * were pregnant, lactating, less than 6 months post-partum, or planned to become pregnant during the time frame of the intervention * unwilling to attend group intervention meetings, assessments or to complete an activity diary for the duration of the study.

Keywords: physical activity intervention walking tv sedentary
randomized trial of cold emr compared to hybrid cold emr.

Conditions: Polyp of Colon; Endoscopic Mucosal Resection

Summary: the goal of this randomized clinical trial is to learn if a combination of hot and cold emr technique is associated with a lower risk of polyp recurrence without increasing the risk of complication when removing large polyps. participants will undergo emr and return for a follow-up endoscopy in 3-6 months to check for polyp recurrence.


Eligibility criteria:
inclusion criteria: * adult patient (age 18 years or older) * polyp size of at least 20 mm * - morphology: flat or superficially raised polyp morphology (i.e., paris classification 1s, 0-iia or 0-iib, or a combination of the above) exclusion criteria: * polyps with previous failed resection attempts or polyp recurrence * suspected deep submucosal invasion on endoscopic assessment of surface mucosal pit pattern (kudo v or nice 3 pattern) or histologically confirmed malignancy (invasive adenocarcinoma) * polyps with nodules too large (\>1-1.5cm) for the use of a cold snare * inflammatory bowel disease

Keywords: emr cold emr hybrid emr endoscopic mucosal resection
comparison of the efficacy and quality of life of three bleaching products

Conditions: Tooth Bleaching; Quality of Life

Summary: the aims of this study are: to compare the efficacy of three different dental bleaching products; to evaluate colour relapse following dental bleaching treatment at 1, 3 and 6 months follow up; to evaluate the impact in quality of life from dental bleaching treatments. products to be used represent three different techniques and formulations: in office, universal tray and custom tray (respectively vivastyle paint on plus (ivoclar vivadent, liechtenstein), opalescence go 6% (ultradent, usa) and opalescence pf 15% (ultradent, usa). all products contain 6% hydrogen peroxide or its equivalent.


Eligibility criteria:
inclusion criteria: * be at least 18 years old * be willing to refrain from use of tobacco products during the study * be willing to sign an informed consent form * at least one teeth 13,11,21,23,33,43 has a gradable vita shade a3,5 or darker by clinical assessment exclusion criteria: * teeht with restorations in frontal teeth * patients with untreated periodontitis or caries * patients with fixed orthodontics appliances * patients with know allergies to ingredients * patients who are nursing or pregnant * patients with severe systemic illnesses * patients with development tooth anomalies * patients with non vital anterior teeth * patients with insufficient oral hygiene

Keywords: tooth bleaching quality of life
effects of a lower limb strength training program on a seated robotic device in patients

Conditions: Stroke

Summary: the loss of lower limb strength that occurs after an acquired brain injury (abi) limits the patient's autonomy in participating in activities of daily living, including gait performance. in the sub-acute phase, it is difficult to implement a strengthening program, as weakness prevents exercise being performed with the recommended parameters. this limit can be exceeded by using specific robotic devices, which allow the effort provided to be adapted according to the patient's capacities. in addition, motivation can be improved by the use of feedback or incentive games. the aim of this pilot study is to obtain data on the effect of lower limb strength training with a seated robotic device in subacute abi patients for a future larger randomised study. in addition, it aims to evaluate the recruitment rate, applicability, resources for implementation and patient tolerance to the training program.


Eligibility criteria:
inclusion criteria: * acquired brain injury of vascular, traumatic, infectious or tumoral origin in the subacute phase * walking ability ≤ functional ambulatory category level 5 (1-6) * paresis of the lower limb: strength \<57/100 on the motricity index * cognitive and memory functions allowing the patient to follow treatment instructions and give informed consent exclusion criteria: * significant heart problem * venous thrombosis less than 6 months * musculoskeletal impairment not compatible with movement * degenerative neurological disease * oxygen-dependent * blood pressure not stabilized

Keywords: lower limb robotic device strength training subacute rehabilitation
d-care - the dementia care study: a pragmatic clinical trial of health system-based versus community-based dementia care

Conditions: Dementia

Summary: d-care: the dementia care study this pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the united states, compares the effectiveness and cost-effectiveness of 18 months of health systems-based dementia care provided by a dementia care specialist (nurse practitioner or physician assistant) who works within the heath system versus community-based dementia care provided by a care consultant (social worker, nurse, or therapist) who works at a community-based organization (cbo). the trial will also compare the effectiveness and cost-effectiveness of both models versus usual care.

d-care: the dementia care study objective: to determine the comparative effectiveness and cost-effectiveness of two evidence-based models of comprehensive dementia care, as well as the effectiveness and cost-effectiveness of both models versus usual care. design: a pragmatic randomized 3-arm superiority trial. the unit of randomization is the patient/caregiver dyad. duration: 6.5 years. this includes 34 months for recruitment of study participants, 18 months of interventions/usual care, and simultaneously 18 months of follow-up for research purposes.

Eligibility criteria:
inclusion criteria: * the person with dementia has a diagnosis of dementia established by a physician or other primary care provider * the person with dementia has a primary care provider who is willing to partner with the study * the person with dementia has a caregiver who speaks english or spanish, and has a phone * persons living with dementia in assisted living facilities will be eligible if they do not meet any exclusion criteria (however, no more than 25% of participants can be living in assisted living facilities at the time of enrollment. this will be monitored when the first 25% of the sample has been enrolled.) exclusion criteria: * the person with dementia resides in a nursing home at the time of recruitment * the person with dementia is enrolled in hospice at the time of screen * the person with dementia plans to move out of the area within the coming year * the caregiver of the person with dementia is unwilling or anticipates being incapable of providing self-reported outcome measures for 18 months * baseline measures refused or not completed * the caregiver is paid, and is not a relative or close friend of the person with dementia * at telephone or in-person screener, the caregiver has cognitive impairment * the person with dementia or caregiver is participating in another dementia intervention study * patients and caregivers who are members of a sites' local patient \& stakeholder committee * there is already a member of the same household participating in the study.

Keywords: dementia pragmatic clinical trial effectiveness cost-effectiveness alzheimer's disease
ultrasound assessment of rectus femoris cross-sectionnal area following lung transplantation

Conditions: Lung Transplant; Physiotherapy; Sarcopenia

Summary: in france, the profile of patients receiving lung transplants has changed in recent years, mainly due to the advent of treatment for cystic fibrosis. this progress has led to an evolution in the patient profile, with an increase in cases of pulmonary fibrosis or copd, and an increase in the average age of patients. in these older patients, sarcopenia, a condition characterized by loss of muscle mass, is a major concern, as it exacerbates morbidity and mortality. after transplantation, patients are at risk of developing neuromyopathy due to their hospitalization in intensive care. there is currently no effective preventive treatment for this condition, underlining the need for early rehabilitation strategies. the combination of sarcopenia and neuromyopathy diminishes their functional capabilities on discharge from the icu. muscle ultrasound, a simple, non-invasive technique, is already used to assess muscle function in intensive care patients. this study aims to evaluate the use of ultrasound to measure muscle loss in lung transplant patients, in particular by examining the rectus femoris muscle. objectives include observing variations in the surface area of the rectus femoris muscle before and after transplantation, identifying factors influencing this variation, and exploring its relationship with post-transplant morbidity. in summary, this study seeks to better understand muscle loss in lung transplant patients using ultrasound, in order to identify risk factors and guide the development of post-transplant rehabilitation strategies.


Eligibility criteria:
inclusion criteria: * patient over the age of 18 * patient registered on the lung transplant list at hôpital foch for a single or double-lung transplant * patient who did not object to inclusion in the study * patient affiliated to a french health insurance plan exclusion criteria: * patient listed for a combined transplant (heart-lung, liver-lung, lung-kidney) * patient on national priority list (super-emergency) * pregnant or breast-feeding patient * patient under guardianship
pharmacokinetic study of paracetamol in patients over 80 years hospitalized to an acute geriatric ward

Conditions: Pain

Summary: the goal of this exploratory study is the characterization of the pharmacokinetic (pk) profile of paracetamol in older patients and the specific pk (pharmacokinetic) variables associated with plasma exposure in this population.

the goal of this exploratory study is the characterization of the pharmacokinetic profile of paracetamol in older patients and the specific pk variables associated with plasma exposure in this population. the primary endpoint is the identification of the pharmacokinetic parameters: area under the curve (auc), peak plasma concentration after administration of paracetamol (cmax) and the time at which the cmax is observed (tmax) of paracetamol. the secondary endpoint consists of 3 sub-endpoints: 1. the variability in plasma exposure: volume of distribution (vd), clearance (cl) and elimination half-life (t1/2) 2. the association between the pk parameters and pathophysiological factors 3. the correlation between pk parameters and clinical parameters.

Eligibility criteria:
inclusion criteria: * a minimum age of 80 years * admission to the acute geriatrics ward * oral intake of paracetamol 1000 milligram (mg) in tablet form tid * a steady state situation (defined as at least 4 consecutive intakes of paracetamol before sampling) exclusion criteria: * palliative care setting with downgrading of care
clinical trial with precizon presbyopic

Conditions: Cataract; Presbyopia

Summary: the purpose of this clinical trial is to evaluate the effectiveness of the precizon presbyopic.

prospective, open-label, single-arm, multicenter clinical evaluation with a 3 months follow-up. the precizon presbyopic is a lens intended for implantation in the capsular bag, indicated for optical correction of aphakia in adults whom the crystalline lens has been removed and who desire presbyopia correction. the main objective is to evaluate the ability of the precizon presbyopic to provide near, intermediate and distance vision in patients undergoing cataract extraction / clear lens exchange (cle) and intraocular lens implantation. study results will be used for ce-approval and registration and marketing purposes.

Eligibility criteria:
inclusion criteria: * presbyopic * cataract patient or clear lens extraction (cle) candidate * patients wishes to be spectacle independent for near and far vision * patient lifestyle and outlook fit with multifocal iol implantation * qualifies for bilateral implantation * patient must have a calculated iol power within the available diopter range * expected best corrected visual acuity of 0.5 snellen decimal or better after iol implantation. * no secondary surgical procedure planned during the course of the study * availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study * patients must provide written informed consent * the predicted keratometric postoperative astigmatism (calculated with respect to the surgical induced astigmatism) must be \<1.0 d. exclusion criteria: * ocular disease other than cataract that may predispose for future complications or might confound the outcome of the investigation (e.g. anterior segment pathology, glaucoma, corneal dystrophy, ocular inflammation, pseudoexfoliation syndrome, retinal disorders) * acute or chronic disease or illness or use of medication that could confound the outcome of the study or increase the risk to the subject * endothelial cell count \<1500 cells/mm2 * amblyopia * congenital eye abnormalities * previous ocular surgery that might confound the outcome of the investigation or increase risk to patient * concurrent participation or participation during the last 30 days in any other clinical trial * patient must not be pregnant or has another condition with associated fluctuation of hormones that could lead to refractive changes
nice: neuroimaging in cessation education

Conditions: Stroke; Smoking Cessation

Summary: the investigators aim to examine the effect on smoking cessation rate by showing stroke patients who are active smokers images of their strokes.

the investigators hypothesize that showing actual images of a patient's stroke to the participant on either brain ct or mri will be a similarly easy to understand quantification of damage done to the participant's body. given the link between smoking and stroke risk, the investigators believe that providing this imaging in addition to standard smoking cessation education may improve rates of smoking cessation after stroke. if this proves true, addition of a patient's neuroimaging to standard post-stroke smoking cessation education would be an easy method to improve smoking cessation rates in stroke patients, at minimal cost.

Eligibility criteria:
inclusion criteria: * age ≥18 * active smoker, as defined: at least 100 cigarettes in their entire life, must have smoked cigarette at least once in 4 days prior to onset of stroke * primary ischemic or hemorrhagic stroke identified on neuroimaging (mri dwi/adc or ct of brain) * onset of stroke symptoms within 30 days to time of recruitment * capacity to comprehend counseling data: each participant will be given a cognitive screening test to assess the ability to comprehend and accurately answer the medical history questionnaire (mmse). if the participant fails this test (score \< 23), they will be excluded. * patients discharged home or short term rehab with expectation of returning home within the study period exclusion criteria: * patients whose stroke deficits clinically prevent them from reasonably being physically able to continue to smoke, such as bilateral upper extremity paresis, tracheostomy, gcs ≥9 * patients with sensory aphasia that impairs comprehension * subarachnoid hemorrhage * transient ischemic attack * other cause of cerebral ischemia or hemorrhage not defined as primary ischemic or hemorrhagic stroke (i.e. hemorrhagic metastases) * patients whose stroke symptoms started \>30 days from time of enrollment * patients discharged to acute rehab, long term acute care hospital or hospice who are unlikely to have access to cigarettes * patients unable to complete cognitive screening test for whom an appropriate proxy does not exist * patients who do not speak fluent english (given that the study largely revolves around oral education on smoking cessation, clear communication between participant and coordinator must be possible)
comparing ascites relief in two standard treatments: large volume paracentesis vs. early tips using viatorr controlled expansion stents

Conditions: Hypertension, Portal; Ascites

Summary: for this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: subjects will get randomized into either group a: large volume paracentesis (lvp) with albumin infusion, or group b: an early transjugular intrahepatic portosystemic shunt (tips) procedure.

end stage liver disease (esld) severely impacts body function leading to elevated blood pressure within the liver called "portal hypertension." one of its subsequent symptoms is ascites, or fluid accumulation in the abdomen. one standard treatment to relieve ascites is large volume paracentesis (puncture of the abdomen to drain the fluid). another standard treatment is the tips procedure, which involves creating a shunt (small passage allowing fluid movement) within the liver to relieve the increased blood pressure in the liver. for this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: subjects will get randomized into either group a: large volume paracentesis (lvp) with albumin infusion, or group b: an early transjugular intrahepatic portosystemic shunt (tips) procedure. the study will include about 68 patients (34 patients will be selected for group a: continuing conservative treatment of lvp with albumin infusion, and 34 patients will be selected for group b: undergoing early tips with gore®viatorr®cx). each patient will be followed up at 1 month, 3 months, 6 months, and 12 months. the primary objective of this study is to evaluate the overall clinical efficacy in symptom relief of ascites of patients receiving the gore® viatorr® cx in early tips procedures compared to lvp (large volume paracenthesis). in order to so, the investigators will be using information found in patient medical records, collected as a part of standard of care, to analyze clinical outcomes, complications, and the rate of secondary interventions at follow-up.

Eligibility criteria:
inclusion criteria: * males and females \> 18 years of age at time of procedure * first de novo tips placement * patent internal or external jugular vein * willing to provide the hepatology service information for follow up * no known diagnosis of hypercoagulopathy * no portal vein thrombosis * no malignancy (must be a definite diagnosis) * patient must provide written informed consent * proper clinical indication of tips based on american association for the study of liver diseases (aasld) guidelines * recurrent ascites necessitating at least 2 large volume paracenteses performed within a minimum interval of 3 weeks exclusion criteria: * age \<18 * lvp \> 6 times in 2 months * liver failure (child pugh \> 12) * cardiac failure * no right jugular venous access * absolute tips contraindications (e.g. right heart failure, severe encephalopathy, liver failure, pregnant (if possible)).

Keywords: end-stage liver disease hepatic encephalopathy cirrhosis