Kornimate/medical-research-clean huggingface dataset:
nutritional status, muscle wasting and fraility in intensive care patients

Conditions: Critical Illness; Nutritional Disorder

Summary: the risk of muscle wasting is high in the intensive care unit patients during the treatment process and this condition is associated with adverse clinical outcomes. the etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in muscle wasting treatment and prevention. the aim of this study is assesing the malnutrition and fraility, anthropometric measurements, and muscle mass by ultrasound at the first admission to the intensive care unit and to determine the nutritional factors affecting clinical outcomes. in addition, it is planned to determine the risk factors affecting the change of anthropometric measurements and muscle wasting in the first week during the intensive care unit.

a nutrition-focused physical examination is an integral component in the assessment of critically ill patients. malnutrition, muscle wasting, and frailty are multidimensional clinical conditions in critically ill patients and are associated with adverse outcomes. although malnutrition, muscle wasting and frailty are linked, the exact relation between them is unsure. as a result of evaluating these conditions together, it is planned to develop new treatment strategies and to improve the clinical results of patients by determining the relationship between medical nutrition therapy.

Eligibility criteria:
inclusion criteria: * age ≥45 years and ≤80 years, male or female * expected icu stay of seven days or longer * written informed consent or requirements of local/national ethical committee exclusion criteria: * pregnancy or breastfeeding * neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, guillain-barre syndrome) * terminal cancer * dialysis dependent chronic renal failure * intoxication * burn injury * a cognitive impairment prior to the acute illness that is associated with admission to icu that would impair capacity to follow verbal instructions * concurrent enrolment in a nutrition-related interventional study at the time of screening
assessment of the effects of mental practice on tongue strength in brain-damaged patients

Conditions: Movement, Involuntary

Summary: the main objective is to evaluate the effects of action-observation training on tongue strength in brain-damaged patients.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 * date of injury : 6 months onwards * medical diagnosis: brain damage or head trauma * clinical diagnosis of dysphagia by videofluoroscopy or v-cam and expert opinion. exclusion criteria: * not understanding verbal or auditory/visual commands through the boston test * present behavioural alterations * presence of seizures * presence of tracheotomy * impulsivity * attention problems

Keywords: action observation
add-on therapy with low dose fenfluramine in lennox gastaut epilepsy

Conditions: Epilepsy; Lennox Gastaut Syndrome

Summary: in this trial, the potential anti-epileptic effect of low dose fenfluramine in lennox gastaut epilepsy will be studied. an exploratory dose finding add-on trial is proposed. at baseline and at the end of the study, ecg and ultrasound of the heart will be performed as part of the safety follow up.


Eligibility criteria:
inclusion criteria electro-clinical epilepsy syndrome compatible with lennox gastaut syndrome: * minimum requirements (based on ilae epilepsydiagnosis.org): * multiple seizure types including in any case tonic seizures * eeg shows slow spike waves and abnormal background * abnormal cognitive development * mri compatible with lennox gastaut epilepsy : no progressive disease * drug resistant: * at least 4 documented seizures in the last 4 weeks before inclusion (minimum 4 seizures in at least 2 separate weeks) seizure types eligible for inclusion are : generalized tonic-clonic seizures gtc , tonic seizures ts , atonic seizures as or clearly recognizable focal seizures fs. * on \>= 2 aeds (including vns) during the 4 weeks before inclusion (no changes in treatment before inclusion and during the trial) * age between 3 and 18 years * subject is male or non-pregnant, non-lactating female. female subjects of childbearing potential must not be pregnant or breast-feeding. female subjects of childbearing potential must have a negative urine pregnancy test. subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 90 days after the last dose of study drug. exclusion criteria * known clinical cardiovascular abnormalities (including valvular problems, shunts, pulmonary hypertension, exercise intolerance) * any cardiac ultrasound/ecg abnormalities at baseline * weight below percentile 3 for age at baseline * subject is receiving concomitant therapy with: centrally-acting anorectic agents; monoamine oxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome p450 (cyp) 2d6/3a4/2b6 inhibitors/substrates. * subject is unwilling to refrain from large or daily servings of grapefruits and/or seville oranges, and their juices beginning with the baseline period and throughout the study.

Keywords: refractory childhood epilepsy lennox gastaut syndrome fenfluramine anti-epileptic treatment
to confirm equivalent bronchodilator efficacy of the test product compared to the reference product

Conditions: Asthma

Summary: the purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.


Eligibility criteria:
main inclusion criteria: * written informed consent * asthma diagnosis for at least 6 months * prebronchodilator fev1 45-90% of the predicted value * demonstration of reversible airway obstruction * stable asthma on the same regular treatment for at least 4 weeks before the study * non-smoker for at least 6 months before the study main exclusion criteria * respiratory infection within 4 weeks before the study * smoking history of more than 10 pack-years * other severe chronic respiratory disease than asthma * concurrent illness that would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study * corrected qt interval \> 450 ms in males or \> 470 ms in females * abnormal serum potassium value or other clinically significant laboratory finding * systolic blood pressure over 180 mmhg and/or diastolic blood pressure over 100 mmhg * treatment with a long-acting β2-agonist, a xanthine-derivative, a β-blocker or with a corticosteroid (other than inhaled) within 4 weeks before the study * use of drugs that prolong qt-interval * women who are pregnant, breast-feeding or without reliable contraception * participation in another clinical drug study
culturally centering medications for opioid use disorder with american indian and alaska native communities

Conditions: Opioid-use Disorder

Summary: this is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder in four healthcare and addiction specialty treatment sites serving american indian and alaska native communities.

this is a formative research study to test a culturally-centered, program-level implementation intervention to increase the use of medications for opioid use disorder (moud) in four healthcare and addiction specialty treatment sites serving american indian and alaska native communities. the study design is a cluster randomized stepped wedge implementation trial with two steps, and two sites per step (n=4 sites). study design and methods are informed by the consolidated framework for implementation research (cfir) and the re-aim framework (reach, effectiveness, adoption, implementation, maintenance). the primary outcome of the trial is the number of consumers with oud initiated onto moud (i.e., buprenorphine, extended-release naltrexone, or methadone) in the 6 months after intervention delivery (compared to the 6 months before intervention delivery) - capturing implementation intervention reach. the primary outcome will be measured at the end of the six-month implementation stage and compared to the pre-intervention observation phase (prior to delivery of the implementation intervention). primary data collection will use de-identified data from the electronic medical records (emr) at each site beginning with data from the six months prior to intervention delivery for step 1 sites and 12 months prior for step 2 sites. for step 1 sites, some secondary outcomes will also be assessed during the sustainment stage (the six months following implementation). as part of the study, consumers with oud will be asked to participate in additional assessments and provide informed consent. enrolled consumer participants will be asked to complete four assessment visits (baseline, week 4, week 8, and week 12) to collect comprehensive information about mental health, cultural connectedness and spirituality, social functioning, and experiences with and acceptability of oud treatment. providers at each clinical site will also be asked to complete surveys at three time points to assess attitudes, knowledge, and readiness related to moud.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * english comprehension and proficiency * receiving services at a participating study site * meet criteria for a current opioid use disorder * self-identify as american indian or alaska native * willing to have program data linked to assessment data * 18 years or older exclusion criteria: * participation in research assessments contraindicated

Keywords: american indian alaska native medications for opioid-use disorder implementation cultural centering
deep brain stimulation of the anterior nucleus of the thalamus in epilepsy

Conditions: Partial Epilepsy; Surgery

Summary: the main objective of the study is twofold: 1. assess the clinical efficacy of dbs on epilepsy according to their number and severity at 1 year follow up. 2. perform a cost-effectiveness analysis from the perspective of medicare at 1 and 2 years. the study hypothesis is that thalamic dbs (neurostimulation of the anterior nucleus of the thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe crises) of the most severe seizures, in at least 50% of patients who have drug-resistant partial epilepsy; and should also improve significantly the quality of life through a gain of independence in activities of daily life, the possible recovery of functional abilities, recovery of social or professional activities.


Eligibility criteria:
inclusion criteria: * patient with focal or multifocal epilepsy with or without secondary generalized seizure inoperable at the time of inclusion * failure of pharmacological therapies (pharmacoresistant epilepsy) for over 4 years (persistent seizures despite at least two anti-epileptic treatments used at the optimal dose for at least 2 years) * failure of vagus nerve stimulation, defined as the persistence of crises considered debilitating after 2 years of vns's treatment * vns failure in a patient treated with vns, for less than 2 years. with stop early due to the worsening crisis * intelligence quotient above 55 * have the written consent of the legal representative for patients under guardianship and minors * affiliation to the french social security system or equivalent * people who signed the consent form * seizure frequency at least 4 crisis / month on average for at least 3 months, about 12 crisis in 3 months objectified by the neurologist during visit pre-inclusion, and confirmed by the neurologist after 3 months of baseline during the inclusion visit exclusion criteria: * patient with a generalized epilepsy immediately * patient with a simple partial seizures (subjective manifestations only) * patient with a cons-indication for mri, a serious intercurrent disease, a progressive brain tumor * patient with a suicide risk of in the six months preceding the inclusion visit (score ≥ 2 on item 10 of the montgomery-asberg depression rating scale) * patient a surgical or anesthetic cons-indication * patient with anticoagulant or antiplatelet treatment in the long term * woman of childbearing potential without effective contraception, or pregnant or lactating * people hospitalized without consent * people deprived of freedom * patient currently participating in another clinical research, or who participated in a clinical study in the month preceding the pre-inclusion visit (except for any non-interventional research)

Keywords: deep brain stimulation anterior nucleus of thalamus treatment refractory pharmacoresistant partial epilepsy vagus nerve stimulation therapy
effects of music on table tennis stroke performance among mentally fatigued university players

Conditions: Mental Fatigue

Summary: the current study is going to investigate the music intervention on the table tennis stroke performance among table tennis stroke performance. the subjects will be instructed to listen to 3 minutes, which can facilitate the recovering process for scope of attention and thought-action repertoire. thus, to see the improvement in stroke performance.

the intervention of this study is music, specifically, instruct subjects to listen inducing positive emotion music due to positive emotion benefit to cognition performance. the condition of mental fatigue will be induced by stroop task. before the intervention or process of listening music, the pre-test will be recorded to compare the post-test value of table tennis stroke performance. moreover, the different music intervention will be implemented to identify the optimal selection.

Eligibility criteria:
inclusion criteria: * university table tennis players. 18-24 years. * both pen-holder and shake-hand play styles. * at least played from the senior school. * at least have 3 years' training experience. exclusion criteria: * color blindness. * any disease or sleep disorder. * smoker or drunker
effects of canagliflozin on intravascular volume and hemodynamics

Conditions: Type2 Diabetes Mellitus; Cardiovascular Diseases

Summary: research hypothesis * in subjects with t2dm and hf, effect of canagliflozin will be superior to placebo for the change from baseline in pcwp after a single dose (6 hours post-dose) and after 4 weeks. * treatment with canagliflozin will be well tolerated over 4 weeks.

this is a randomized, double-blind, placebo-controlled, parallel-group, single-center study (figure 1). thirty subjects will be randomized in a 3:2 randomization ratio to canagliflozin 300 mg once daily (qd) or placebo. the study will include a 3-week pretreatment screening phase and a 4-week double-blind treatment phase.

Eligibility criteria:
inclusion criteria: * on stable doses (more than 3 months) of antihyperglycemic agents (except for an sglt2 inhibitor and insulin) * have an a1c ≥7% and ≤11% * estimated glomerular filtration rate (egfr) must be ≥45 ml/min•1.73 m2 * have an nt-probnp ≥500 pg/ml * be on a stable dose of guideline-directed hf medication (i.e., angiotensin converting enzyme \[ace\] inhibitor, angiotensin ii receptor blocker \[arb\], or angiotensin receptor neprilysin inhibitor \[arni\], β-blocker, diuretics, and/or mineralcorticoid receptor antagonist) for at least 4 weeks * be on stable antihypertensive therapy for at least 2 months exclusion criteria: * t1dm * repeated fasting plasma glucose (fpg) or fasting self-monitored blood glucose measurements ≥240 mg/dl or both * during the pretreatment phase, nyha class iv hf status, uncontrolled hypertension as defined as systolic blood pressure (sbp) \>160 or diastolic blood pressure (dbp) \>100 mmhg * liver disease (alt or ast \>3 x uln) * anemia hb\<10 * anticipated cardiac surgery or coronary intervention within the next 3 months * severe unremediated valvular heart disease * major cv event (e.g., mi, cerebrovascular accident) within 3 months prior to screening visit * hospitalization for hf within 2 months prior to screening visit * documented atrial fibrillation * history of atraumatic amputation within past 12 months of screening or critical ischemia of the lower extremity within 6 months of screening * an active skin ulcer, osteomyelitis, or gangrene * have an allergy to iodocyanine green and inulin
post sustained virological response (svr) hepatocellular carcinoma (hcc) screening

Conditions: Hepatocellular Carcinoma; HCC; Hepatitis C; HCV

Summary: approximately half of the patients receiving treatment for chronic hepatitis c virus (hcv) infection in the united states have advanced liver disease. patients with advanced fibrosis/cirrhosis who achieve a sustained virological response (svr) to treatment and are clinically cured of hcv continue to have an elevated risk of developing hepatocellular carcinoma (hcc). according to guidelines from several professional societies and from the american association for the study of liver diseases (aasld), in particular, patients with advanced fibrosis/cirrhosis should undergo life-long bi-annual screening for incident hcc whether they achieve an svr, or not. the number of patients who need post-svr hcc screening has risen dramatically in recent years due to the confluence of three factors: increased screening for hcv, which has allowed more people to realize that they have this often "silent" infection; the availability of safe and highly effective direct acting antiviral drugs (daas) for hcv, which has allowed a much higher percentage of treated patients to achieve an svr; and the long duration of hcv infection in many patients, which has allowed enough time for advanced fibrosis/cirrhosis to develop. to investigate post-svr patients in the era of daas and to promote hcc screening, the objective of this study is to conduct a randomized, unblinded, two-arm prospective intervention trial comparing rates of hcc screening between patients randomized to either personalized patient navigation or automated reminders (e.g. electronic or mailed). both interventions represent improved care over current standard of care (no patient navigation or automated reminders). there is no evidence to suggest one intervention is better than the other. healthcare providers who agree to participate in the study will be contacted to confirm the liver disease status of their patients and during the clinical trial the providers of patients in both arms of the trial will be sent reminders about the need to schedule patients for screening visits.


Eligibility criteria:
inclusion criteria: * ≥21 years old * history of hcv infection treated in 2011 or after with direct acting antiviral therapy * achieved ≥svr-12 as defined as no detectable virus 12 weeks or longer after the cessation of therapy * fib-4 ≥3.25 * no history of hcc prior to treatment * hcv provider deems a subject eligible for hcc surveillance according to aasld criteria * able to understand and speak english * willing to sign the informed consent * have a working phone number or e-mail to reach them * no history of liver transplantation.

Keywords: sustained virological response svr patient navigation screening hcc hcv
star-close early ambulation trial

Conditions: Cardiovascular Disease

Summary: to confirm that patients who receive the star-close vascular closure system (vcs) can safely ambulate within 30 minutes of catheterization.

to confirm that patients who receive the star-close vascular closure system (vcs) after diagnostic cardiac catheterization can safely ambulate within 30 minutes of catheterization.

Eligibility criteria:
inclusion criteria: * patients admitted to for an outpatient left heart catheterization * catheterization through the femoral artery * able to ambulate at least 20 feet * able to receive the star-close vascular closure system * be a candidate for hospital discharge following catheterization exclusion criteria: * known peripheral arterial disease * blood pressure greater than 180/110 * pregnant or lactating * anemic or low blood count * blood thinning medication within 5 days before catheterization * unable to walk 20 feet with out rest * complications during catheterization procedure

Keywords: cardiac catheterization walk heart catheterization coronary disease heart disease coronary artery disease
an open-label study of serum testosterone levels in non-dosed females after secondary exposure to testosterone gel 1.62% applied to the upper arms and shoulders and use of a t-shirt barrier

Conditions: Healthy

Summary: single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of testosterone gel 1.62% formulation.

single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of testosterone gel 1.62% formulation.

Eligibility criteria:
inclusion criteria * bmi between 20-35 kg/m\^2 inclusive. exclusion criteria * males: history, current or suspected prostate or breast cancer. * females: pregnant or lactating.

Keywords: testosterone, pharmacokinetics replacement, therapy
diffusion tensor imaging to assess the functional outcomes of adults with cervical spinal cord injuries

Conditions: Cervical Spinal Cord Injury

Summary: acute changes in axial diffusivity will correlate with the severity of injury in patients that suffer an acute spinal cord injury.

diffusion tensor imaging (dti) parameters will correlate with severity of spinal cord injury in sci patients as seen in rodent models. we will test whether the quantitative decrease in axial (λ║) diffusivity (a biomarker of axonal injury), will predict long-term functional outcomes for patients with a sci. specific aim: to examine patients after an acute sci using dti and to correlate the extent of acute decrease in λ║ with the presenting asia motor score and long-term functional outcome of the patient.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * cervical spinal cord injury * physically and mentally willing to comply with imaging * lives in immediate area with no plans to relocate exclusion criteria: * associated moderate to severe head injury * active malignancy * previous spinal cord injury * pregnancy * inability to tolerate mri scanning

Keywords: trauma spinal cord injury cervical spine
kinesio taping in muscle damage response induced by eccentric exercise

Conditions: Bandages; Muscle Soreness

Summary: sixty volunteers with a mean age of 21,8 ± 2,6 years participated in this study, randomly distributed into one of the following groups: control, kinesio taping group with tension in the anterior arm region and kinesio taping group without tension in the same region. all subjects underwent an eccentric exercise protocol and three evaluations: before the protocol, immediately after and 48h after protocol. the following variables were analyzed: sensation of pain as the primary outcome; peak torque normalized by body weight; average peak torque; total work and average power, using an isokinetic dynamometer. in addition, muscle activation amplitude (root mean square) and median frequency were recorded using surface electromyography.


Eligibility criteria:
inclusion criteria: * female between 18 and 28 years; * bmi below 30; * practicing recreational physical activity at least three times a week without training at a competitive level; * exhibiting shoulder joint, elbow and non-dominant hand integrity; * do not having a history of osteo-myoarticular injuries in the assessed limb in the last 6 months. exclusion criteria: * does not run the tests properly; * be allergic to tape test; * does not attend all assessments.