Kornimate/medical-research-clean huggingface dataset:
practicability of gliding aids for medical compression stockings

Conditions: Chronic Venous Insufficiency; Post-thrombotic Syndrome

Summary: medical compression stockings are highly effective in the prevention, treatment, and secondary prevention of chronic venous insufficiency and of post-thrombotic syndrome. non-adherence to the prescribed compression treatment concerns approximately 40% of patients. elderly patients are often unable to handle stockings in order to put them on properly in the morning and to undress in the evening. gliding aids and stocking "butlers" are two types of tools to facilitate the dressing manoeuvre with medical stockings. the present study evaluates four different gliding aids and two different stocking "butlers" to put on three different types of compression stockings. the study is conducted with forty consenting subjects with advanced chronic venous insufficiency.

subjects: 40 consenting patients \>65y old, with ceap c4-6 chronic venous insufficiency stockings: one class 3 (36 - 46 mmhg interface pressure) with closed tip one class 3 with open tip two superimposed class 1 (18 - 21 mmhg) gliding aids and stocking "butlers" three types of gliding aids for closed tip stockings three types of gliding aids for open tip stockings two types of stocking "butlers", one optional with mounted handles

Eligibility criteria:
inclusion criteria: \> 65 years old chronic venous insufficiency ceap c4-6 exclusion criteria: dementia blindness paraplegia

Keywords: chronic venous insufficiency post-thrombotic syndrome medical compression therapy compression stocking gliding aid stocking butler adherence to treatment
angio-seal vip versus perclose proglide for closure of the femoral artery in peripheral vascular disease

Conditions: Peripheral Vascular Diseases; Percutaneous Intervention Via Femoral Artery

Summary: this study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of perclose proglide (abbott vascular devices) for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with angio-seal vip (st. jude medical).

prospective, single-center, randomized (1:1), open-label, non-inferiority study in 1062 patients comparing perclose proglide (test device) to the angio-seal vip (standard comparator).

Eligibility criteria:
inclusion criteria: * patient is ≥18 and \< 85 years of age. * patient is willing to provide written informed consent prior to study device use. * patient is undergoing a peripheral vascular diagnostic and/or interventional procedure via femoral arterial access. * patients' arterial puncture site is in the common femoral artery confirmed by a femoral angiogram, and ≥10mm away from the ostium of the inferior epigastric artery (iea) and the bifurcation of superficial femoral artery and the profunda femoris artery. exclusion criteria: * the femoral access site has been punctured within 30 days, or deployed with a collagen-based hemostasis device within 90 days, or a suture-mediated closure device. * patients having a hematoma, pseudoaneurysm or arteriovenous fistula present prior to sheath removal confirmed by a femoral angiogram. * patients with minimum femoral artery calcium which is fluoroscopically visible at access site or femoral artery diameter stenosis greater than 50%. * ankle-brachial index (abi) of the ipsilateral limb of access site cannot be measured due to severe peripheral artery disease (pad). * patients who are pregnant or lactating.

Keywords: peripheral vascular diseases closure device femoral artery
diagnostic interest of the irap protein (insulin regulated amino peptidase) in insulin resistance

Conditions: Insulin Resistance Syndrome

Summary: there is currently no reliable, diagnostic tests of insulin resistance other than the hyperinsulinemic euglycemic clamp which, due to its constraints and cost, is reserved for research. the insulin-regulated aminopeptidase (irap) protein is a direct marker of insulin-dependent glucose cell capture and thus it blood concentration seems to be a good diagnostic test of insulin resistance. the purpose of this study is to assess a plasma essay of irap protein for evaluation of insulin resistance during an oral glucose tolerance test (ogtt).

this study consists of two visits, from three to fifteen days apart. patients with different levels of insulin resistance will be enrolled in this study. the level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp that will be performed at the second visit. the first visit : * subjects will be on an empty stomach * a blood test including hba1c, c-peptid, lipid profile, creatinine,urea, hepatic workup * an oral glucose tolerance test (ogtt) of 3 hours will be performed. blood samples will be taken two time (t-15', t0) 15 minutes apart at baseline (before taking the glucose). and then after the glucose intake, blood sample will be taken every 15 minutes (t15', t30', t 45', t60', t75', t90', t105', t120' and 180') to measure insulinemia, blood sugar, and irap concentration. the second visit includes a 3-hours hyperinsulinemic euglycemic clamp.

Eligibility criteria:
inclusion criteria: * patient without known diabetes * abdominal perimeter greater than 80 cm for women and greater than 94 cm for men * patient affiliated to social security insurance or beneficiary of social security insurance. * signed consent exclusion criteria: * consumption of narcotic * medication that may interfere with glucose metabolism * history of bariatric surgery * known acute or chronic renal insufficiency * hyperinsulinemic euglycemic clamp contraindication * contraindications with insulin, g20 glucose and di-potassium phosphate * histories of coronary pathology * history of heart rhythm disorders requiring chronic treatment * period of fast * pregnant women

Keywords: irap insulin regulated amino peptidase
optimization of adaptive text messages for cancer survivors (oats ii)

Conditions: Colon Adenocarcinoma; Colorectal Carcinoma; Rectal Adenocarcinoma

Summary: this clinical trial evaluates whether an adaptive text-message intervention is useful in helping survivors of colorectal cancers (crc) eat more whole grain foods and less refined grain foods. most crc survivors don't achieve the recommended intakes of whole grains or fiber, even though there is strong evidence that a high-fiber diet rich in whole grains lowers the risk of death from crc. dietary interventions are a promising approach for reducing death from crc, and text message interventions specifically are a promising tool for reaching diverse populations. this trial evaluates a text-message based dietary intervention that continuously adapts message content to be specifically tailored for the participant for increasing whole grain consumption.

primary objective: i. determine the intervention's feasibility and acceptability. secondary objectives: i. estimate the effect of the intervention on the percent of grains consumed that are whole. ii. estimate the effect of the intervention on total fiber intake (grams per day \[g/d\]). exploratory objective: i. assess convergence of the reinforcement learning (rl) algorithm. outline: patients receive nutrition education materials and then receive the adaptive text message intervention for 12 weeks on study. patients who are food insecure also receive resources for food banks, information about meal delivery programs, and support for applying for supplemental nutrition assistance program (snap) benefits.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. subject has provided informed consent. 3. diagnosis of colon or rectal adenocarcinoma. 4. not on active treatment at the time of screening and not expected to receive active anticancer therapy (e.g., surgery, radiation, chemotherapy) during the study period. 5. at least 6 weeks since a major surgery and fully recovered. 6. owns a mobile phone and is willing and able to receive and send text messages. 7. able to speak/read english or spanish. 8. based on a screening survey, eat grains and =\<50% of total grains are whole grains. exclusion criteria: 1. does not meet any of the above inclusion criteria.
managed access programs for tqj230, pelacarsen

Conditions: Atherosclerotic Cardiovascular Disease, ASCVD

Summary: the purpose of this registration is to list managed access programs (maps) related to tqj230, pelacarsen

ctqj230a12013m - available - managed access program (map) cohort treatment plan (ctqj230a12013m) to provide access to pelacarsen (tqj230) for (atherosclerotic cardiovascular disease, ascvd)

Eligibility criteria:
inclusion criteria: 1. an independent request was received from a licensed physician. 2. the patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment. 3. the patient is not eligible or able to enrol in a clinical trial or continue participation in such trial. 4. there is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. 5. the patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable). 6. provision of the product will not interfere with the initiation, conduct, or completion of a novartis clinical trial or overall development program. 7. managed access provision is allowed per local laws/regulations.

Keywords: map manage access program tqj230 pelacarsen atherosclerotic cardiovascular disease ascvd
preoperative nutritional support in malnutritional cancer patients

Conditions: Pancreatic Cancer; Biliary Cancer; Malnutrition

Summary: malnutrition patients are known to have more postoperative complications and mortality. and most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the aspen (american society of parenteral and enteral nutrition) and espen (european society of parenteral and enteral nutrition) guideline. however there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients. the purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating hbp surgery. primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.

this is single arm study with historical comparison. the historical control group did not receiving nutritional support. in previous results show that about 25% complication rates. complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (nccncs-11-460)). for support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. nutritional support program is briefly described below. interval: 5-10 days contents: admission is required * calories: 30-35kg, via enteral or parenteral * protein: 1.2-1.5g/kg * lipid : 1-1.5g/kg * mineral and vitamins supply * blood glucose control * daily monitoring by dietician and specialized nurse

Eligibility criteria:
inclusion criteria: 1. subjects in anticipating major surgery of hepatobiliary pancreatic cancer 2. patients diagnosed with malnutrition (at least more than one) 1. pg-sga b or c 2. weight loss \>10% within 6 month 3. bmi \<18.5 4. serum albumin \<3.0 3. age less than 80 years old over 20 years old 4. performance status (ecog scale): 0-1 5. adequate organ functions 1. hb ≥7.0 g/dl 2. anc ≥1,500/mm3 3. plt ≥80,000/mm3 4. liver function: ast/alt ≤5×upper limit of normal 5. creatinine ≤2.0 uln exclusion criteria: 1. biopsy, drainage tube insertion, and other minor surgery 2. palliative surgery 3. serious illness or medical conditions, as follows; 1. congestive heart failure (nyha class iii or iv) 2. unstable angina or myocardial infarction within the past 6 months, 3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree av block 4. uncontrolled hypertension 5. hepatic cirrhosis( ≥ child class b) 6. interstitial pneumonia, pulmonary adenomatosis 7. psychiatric disorder that may interfere with and/or protocol compliance 8. unstable diabetes mellitus 9. uncontrolled ascites or pleural effusion 10. active infection 4. pregnancy 5. any patients judged by the investigator to be unfit to participate in the study

Keywords: malnutrition nutrition nutritional support hepatobiliary pancreatic cancer hepatobiliary pancreatic surgery
bis and entropy in deep brain simulation

Conditions: Movement Disorders; Depth of Anesthesia Monitors

Summary: the main objective of the study is to determine whether depth of anesthesia (doa) monitoring such as bispectral index (bis) and entropy are accurate in patients with neuro-psychological conditions such as parkinson's disease by comparing these monitoring with standard clinical monitoring like heart rate, blood pressure and respiratory rate.

deep brain simulation (dbs) is an increasingly popular treatment for movement and psychiatric disorders such as parkinson's disease and dystonia. these patients are quite sensitive to anesthetics and use of depth of anesthesia monitors are often needed to titrate the anesthetics. the calibration of bis and entropy monitors has been done only on subjects with no neurological diseases. the investigators plan to record bis and entropy readings during general anesthesia (ga) for the internalization of dbs electrodes. this would be useful as there are very few studies in this subset of patients with regards to doa monitoring. ashraf argued that the eeg may be altered under these circumstances and hence produce invalid bis readings. pemberton et al. studied patients undergoing tumour surgery using a sleep- awake-sleep anaesthesia technique. they found a poor correlation between bis values and the observer's assessment of anesthesia level, suggesting that bis is not a reliable tool for patients with brain abnormalities. the purpose of this study was to investigate whether bis and entropy are helpful in titrating doa in patients undergoing neurosurgical procedures or suffering from neurological diseases as they were frequently excluded from validation studies of the bis monitoring device.

Eligibility criteria:
inclusion criteria: * adult patients older than 18 years of age scheduled for elective internalisation of dbs electrodes under general anesthesia. exclusion criteria: * lack of informed consent * language barrier * those that are transferred to an intensive care unit postoperatively.

Keywords: depth of anesthesia monitors deep brain stimulation
primary prevention of chd risk factors occurring in us

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Heart Disease Risk Reduction; Coronary Disease; Hypertension; Hypercholesterolemia

Summary: to evaluate the effectiveness of primary prevention of coronary heart disease risk factors by examining data from the national health examination survey (nhes) and the national health and nutrition examination surveys (nhanes) to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts.

background: the coronary heart disease risk factor profile of americans has been improving, with decreasing blood pressure and cholesterol levels. however, it is not apparent whether this improvement is due to primary prevention of risk factors through lifestyle choices or to secondary prevention (management) of established risk factors. since secondary prevention only targets people with high blood pressure or cholesterol levels, the effect should be demonstrated by temporal declines in the upper percentiles (75th, 90th) of the blood pressure and cholesterol distributions. primary prevention should shift the entire risk factor distribution, including the percentiles in the middle (50th) and lower (10th, 25th) portions of the distribution. thus, the effectiveness of primary prevention programs can be evaluated by examining temporal changes in the middle and lower percentiles, and the effectiveness of secondary prevention can be evaluated by examining temporal changes in the higher percentiles. design narrative: data from the national health examination survey and the national health and nutrition examination surveys were examined to determine whether more recent birth cohorts were attaining lower blood pressure and cholesterol levels than earlier birth cohorts. the results of these analyses provided information that may help guide further research and application of population prevention strategies. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
goal management training for patients with schizophrenia or high risk for schizophrenia

Conditions: Schizophrenia; Neurocognitive Disorders

Summary: about 85% of patients with schizophrenia have cognitive impairments, executive functions being particularly affected. executive dysfunction, and cognitive deficits in general, are important predictors of functional outcomes, including social problem solving, activities of daily living, life satisfaction, and the ability to return to work or school.the main objective of the current study is to examine the efficacy of group-based goal management training (gmt) for patients with broad schizophrenia spectrum disorders or high risk individuals with executive deficits. the short term goals are to investigate whether gmt can improve participants' ability to organize and achieve goals in everyday life in addition to improving aspects of emotional health. a long-term goal would be to establish an evidence base for nonpharmacological interventions for patients with broad schizophrenia spectrum disorders or high risk for schizophrenia. main research questions: (1) does a rct with gmt delivered to patients with broad schizophrenia spectrum disorders or high risk for schizophrenia result in improved executive functioning, measured by self-reported and/or objective measures of executive functions? (2) does gmt result in improved goal attainment in everyday life, social- and real world functioning? (3) does gmt have a positive impact on the patients' emotional health? (4) are there specific characteristics in patients with broad schizophrenia spectrum disorders or high risk for schizophrenia that are associated with better treatment benefit from gmt?


Eligibility criteria:
inclusion criteria: * being consecutively referred to treatment for a dsm-iv diagnosis of broad schizophrenia spectrum psychosis (schizophrenia, schizophreniform disorder and schizoaffective disorder) or high risk for psychosis or being treated for psychotic disorder for less than 5 years. * reporting executive problems through (a) structured interview, or (b) self-report, i.e. brief scale t-score \< 55. exclusion criteria: * reported ongoing alcohol or substance abuse. * premorbid neurological disease or insult and/or comorbid neurological disease. ° severe cognitive problems interfering with the capacity to participate. * iq below 70.
chronotype and premature ejaculation

Conditions: Premature Ejaculation

Summary: chronotype (or circadian preference) has previously been shown to be associated with sexual attitudes and behaviors and is an important factor affecting sexual satisfaction. the fact that some neurobiological variables, which are thought to have a role in ejaculation physiology, are also effective in the processes of sleep and the regulation of circadian rhythm, and evidence supporting the relationship between circadian preferences and sexual desire and sexual behavior; suggests that ejaculation disorders may be related to circadian preference. the aim of the present study was to investigate the relationship between intravaginal ejaculatory latency time (ielt), severity of disease and chronotype in lifelong pe.

after being informed about the study, all patients who gave written informed consent were questioned and diagnosed as lifelong pe according to the definition of international society of sexual medicine (issm) by an experienced urologist. since erctile dysfunction (ed) may accompany pe, the presence of ed symptoms was evaluated by the international index of erectile function (iief-5), and those with iief-5 score \<22 were excluded from the study. age- and sex-matched control cases without lifelong pe were selected randomly among cases attending the hospital for a checkup procedure. a total of 114 patients with pe and 103 control subjects with similar sociodemographic characteristics were included in the study. a detailed medical and sexual history was taken, which included self-estimated intravaginal ejaculatory latency time (ielt), by an experienced sexual therapist. moreover, arabic index of premature ejaculation (aipe), pittsburgh sleep quality index (psqi) and morningness-eveningness questionnaire (meq) were administered to all participants.

Eligibility criteria:
inclusion criteria: * male between the ages of 18-50 years, * being sexually active, and in a stable relationship with a single partner for the last 6 months * meeting diagnostic criteria of premature ejaculation according to issm. exclusion criteria: * having a history of neurological and/or psychiatric disorders, any malignancies, sexual dysfunction other than pe, chronic systemic disease, or if they were taking alpha-blockers, phosphodiesterase type-5 inhibitors, 5-alpha reductase inhibitors, anticholinergics, antipsychotics, or antidepressants. * presence of obesity (body mass index (bmi)\> 30) * presence of erectile dysfunction (iief-5 score \<22)
efficacy and safety study of botulinum toxin type a against placebo to treat abnormal contraction or twitch of the eyelid

Conditions: Bilateral Blepharospasm (BEB)

Summary: this phase 3 study will serve to collect efficacy and safety data of two different doses of nt 201 in subjects suffering from bilateral blepharospasm (beb) who are btx treatment-naïve. in this study, btx treatment-naïve subjects are defined as those who have not received btx treatment within the last 12 months for the treatment of beb. this definition aims to avoid bias by comparison of treatment effects in the subject's assessments. furthermore, this study will substantiate the existing efficacy and safety database for the indication beb.

subjects to receive one injection with nt 201 or placebo at baseline of the placebo-controlled first cycle. thereafter, all subjects entering the open-label extension period (olex) to receive a second injection of nt 201 (second injection cycle).

Eligibility criteria:
inclusion criteria: * male or female out-patients age ≥ 18 and ≤ 80 years. * a clinical diagnosis of bilateral beb characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of orbicular oculi muscles. * a need for injection of btx defined as a jankovic rating scale \[jrs\] severity subscore ≥ 2. * treatment-naïve subject defined as at least 12 months without btx of any serotype for the treatment of beb before administration of ip. exclusion criteria: * subject with any previous unsuccessful treatment with btx of any serotype for the treatment of beb. * atypical variant of beb (e.g., apraxia of the eyelid opening) caused by inhibition of levator palpebrae muscle. * neuroleptic-induced blepharospasm. * myotomy or denervation surgery in the affected muscles (e.g., peripheral denervation, spinal cord stimulation) and surgery in the upper face. * generalized disorders of muscles activity (e.g., myasthenia gravis in particular ocularis, lambert-eaton-syndrome, amyotrophic lateral sclerosis) or any other significant neuromuscular dysfunction which might interfere with the study.