Kornimate/medical-research-clean huggingface dataset:
hybrid robot+fes stroke rehabilitation

Conditions: Stroke

Summary: the investigators have developed a novel robot-guided stretching under intelligent control and combine it with active movement training, which helped increase joint rom, reduce spasticity and joint stiffness, increase muscle force output, and improve locomotion. however, for stroke survivors with sensorimotor impairment, their peripheral muscle may not sufficiently be recruited. functional electrical stimulation (fes), has been shown its advantage to activate the peripheral muscles for people with neurological conditions. the investigators thus make a hybrid robot-fes rehabilitation system, combining the advantage of robot and fes technologies for stroke motor recovery. the investigators further would like to translate the technologies from lab to home-based training. thus, the investigators will conduct a randomized, controlled, primarily home-based clinical trial using an ankle robot alone or combined with functional electrical stimulation (fes) to treat sensorimotor and locomotion impairments post-stroke.


Eligibility criteria:
inclusion criteria: * age 18-85; * able to ambulate at least 10 meters without human assistance, with or without an assistive device * ≥ 6 months post stroke; * having a caregiver to assist in training at home. exclusion criteria: * having expressive and receptive aphasia; * an inability to follow multi-step commands; * enrolled in another lower limb rehabilitation program; * having severe pain in the paralyzed lower-limb; * \>30º ankle plantar flexion contracture; * having implanted electronic device such as a pacemaker, spinal cord, or deep brain stimulator because fes may potentially interfere with their functions.

Keywords: stroke functional electrical stimulation robot training
multicenter single-port colectomy rct

Conditions: Colon Neoplasms

Summary: this clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost. the investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

this clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Eligibility criteria:
inclusion criteria: * colon adenocarcinoma * curative resection * age : 20 \~ 85 exclusion criteria: * distal transverse colon cancer * splenic flexure colon cancer * descending colon cancer * emergency operation * obstruction * perforation * asa 3 or 4 * pregnant woman * tumor associated with fap, hnpcc, or ibd * distant metastasis * adjacent organ invasion * synchronous colorectal cancer * other malignancy within last five years

Keywords: single-port laparoscopy colectomy single port colon cancer minimally invasive surgery
photodynamic treatment of actinic keratoses with different light doses

Conditions: Actinic Keratosis

Summary: aim of the study: to evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.

to determine and compare clinical and histological effectiveness of different (70 j/cm2 ir 100 j/cm2) light doses when treating actinic keratoses with photodynamic therapy. to determine pain intensity during photodynamic therapy with visual analogue scale and factors influencing pain during the procedure.

Eligibility criteria:
inclusion criteria: 1. male or female subject older than 50 years. 2. subject has to read patient information sheet and read and sign the informed consent form prior to any study related procedure. 3. ak with the largest diameter ≤3 cm (measuring the longest axis). 4. 2 or more ak with symmetrical distribution on the face or scalp. 5. clinically and histologically confirmed ak of grade i or ii. 6. subject must be willing and capable of cooperating to the extent and degree required by the protocol. 7. patient is not the subject of the administrative or legal judicial proceeding. 8. subject has social health security required by laws of health care institutions. exclusion criteria: 1. patients with more than 5 ak in the planned treatment area. 2. a recurrent ak: ak that has been previously treated in the study area. 3. very hyperkeratotic, grade 3 (on a 0-3 scale) ak lesions among the target lesions. 4. ak located on the nose. 5. other skin lesions (diseases) in the tumor study area. 6. subject with known hereditary basal cell carcinoma syndromes (gorlin-goltz, basex-dupre-christol et al.). 7. subject with a history of cutaneous photosensitization or porphyria or xeroderma pigmentosum, hypersensitivity to porphyrins, or photodermatosis. 8. subject who had received photosensitizing drugs 30 days before study start. 9. subjects who had received immunomodulatory or immunosuppressive therapies, including systemic and topical steroids, imiquimod or solaraze, interferon and acitretin 6 months prior to study treatment initiation. 10. subject who had participated in another investigational drug or device research study within 30 days of enrolment. 11. subject had received in the study area laser resurfacing, chemical peels, topical application fluorouracil or other drugs for the treatment of aks within 2 months before study entry. 12. subject with known hypersensitivity to 5-aminolevulinc acid, a similar compound or excipients of the cream. 13. subject with known status after organ transplantation.

Keywords: actinic keratosis photodynamic therapy 5-aminolevulinic acid
sumco metabolic syndrome project

Conditions: Metabolic Syndrome

Summary: physical activity is considered important in prevention and treatment of obesity and metabolic syndrome. genotype of genes involved in metabolism is also known to be associated with the development of metabolic syndrome. however, scarce evidence exists regarding the influence of physical activity intensity and genotype on metabolic syndrome in people with obesity. the investigators examine physical activity using an uniaxial accelerometer, as well as aerobic fitness using an electric bicycle ergometer, several genotypes of genes related to glucose and lipid metabolisms in middle-aged men with obesity and/or abdominal obesity who were employees in silicon wafer manufacture and participated in a health checkup.


Eligibility criteria:
inclusion criteria: * healthy people and individuals with obesity and metabolic syndrome exclusion criteria: -
bioavailability study of two formulations of sarpogrelate hcl 300mg tablets under fed conditions

Conditions: Healthy

Summary: a single-dose, comparative bioavailability study of two formulations of sarpogrelate hcl 300mg tablets under fed conditions

to evaluate the bioequivalence of two formulations of sarpogrelate hcl 300mg after a single oral dose administration in healthy volunteers under fed conditions

Eligibility criteria:
inclusion criteria: * healthy, non-smoking, male and female subjects, 19 years of age or older * bmi ≥ 18.0 and ≤ 30.0 kg/m2. * females who participate in this study will be of childbearing or non- childbearing potential exclusion criteria: * know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
the effects of vitamin d on glycemic control and proinflammatory markers in adolescents with t1dm

Conditions: Type 1 Diabetes; Vitamin D Deficiency/Insufficiency

Summary: the investigators are conducting a prospective cross-over study to evaluate the effects of vitamin d supplementation on diabetes control and the pro-inflammatory markers involved in microvascular complications in adolescents with type 1 diabetes. the investigators expect to see a significant improvement in glycemic control and a reduction of serum pro-inflammatory markers in adolescents with type 1 diabetes and vitamin d deficiency or insufficiency, who are treated with vitamin d.


Eligibility criteria:
inclusion criteria: 1. between 13 to 21 years of age, with at least tanner stage 4 sexual maturity for males or post-menarchal females, and t1dm for at least 1 year. to ensure that inclusion criteria for sexual maturity are met, a physical exam for research purposes will be performed. 2. hba1c between 7 to 9% 3. adequate renal function (serum creatinine \< 1.5 mg/dl in males and \< 1.2 mg/dl in females) and adequate liver function (ast and alt \< 2.5 times the upper limit of normal) 4. vitamin d insufficiency or deficiency (25-oh vit d level \< 30ng/ml) which will be determined on initial screening labs after consenting subjects. exclusion criteria: 1. less than 13 or greater than 21 years of age 2. less than tanner stage 4 sexual maturity for males or pre-menarche 3. hba1c less than 7% or greater than 9% 4. t1dm for less than 1 year 5. vitamin d sufficient (25-oh vit d level \> 30 ng/ml) 6. currently taking any medication that can interfere with vitamin d synthesis or metabolism, including but not limited to orlistat, phenobarbital, dilantin, anti-tuberculosis drugs 7. currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids 8. inadequate renal function (serum creatinine \> 1.5mg/dl in males and \> 1.2mg/dl in females) or inadequate liver function (ast and alt \> 2.5 times the upper limit of normal) 9. evidence of malabsorption or short gut.

Keywords: diabetes vitamin d proinflammatory markers
pk comparisons of bepotastine besilate 10 mg and bepotastine salicylate 9.64 mg

Conditions: Allergic Rhinitis; Urticaria; Pruritus

Summary: to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed bepotastine formulation, bepotastine salicylate, with a conventional formulation, bepotastine besilate, in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.


Eligibility criteria:
inclusion criteria: * subjects aged between 20 and 45 years * body weight \> 50 kg (in case of female \> 45 kg) with bmi between 18 and 29 kg/m2 * signed and dated informed consent form which meets all criteria of current fda and kfda regulations exclusion criteria: * subjects with acute conditions. * presence of history affecting adme * clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality * hepatitis b, hepatitis c, or hiv infection revealed on the laboratory findings * any other acute or chronic disease * a history of hypersensitivity to bepotastine * a history of alcohol or drug abuse * participation in another clinical trial within 2 months * smoked \>10 cigarettes daily * consumption over 5 glasses daily of beverages containing xanthine derivatives * use of any medication having the potential to affect the study results within 10 days before the start of the study. * medication of the inhibitors or inducers of dme including barbiturates within 1 month * one of abnormal lab findings as like * c. ast/alt \> unl (upper normal limit) x 1.5 * total bilirubin \> unl x 1.5
subjective factors of polymedication in the elderly: a qualitative study of the perceptions of patients, relatives and referent physicians.(dosage)

Conditions: Frail Elderly Syndrome

Summary: the dosage study is a qualitative transversal study aiming to describe and understand the subjective factors of polymedication in the elderly population (75 years old and more), defined as 10 simultaneous drugs. semi-structured interviews will be conducted with patients, relatives and general practitioners in one french region. 20 situations will be included. after analysing the data of the individual interviews, focus groups will be conducted with health professionals.


Eligibility criteria:
inclusion criteria: * for patients: * men and women aged 75 and over * beneficiary of a prescription of medicinal products fulfilling the conditions of major polymedication: to include 10 different drugs whatever the way of use (per os, subcutaneous, intravenous, intra muscular, cutaneous, instillation) * informed consent stating that the subject understood the purpose and methodology of the study and agrees to participate in the study. * for the relatives: * men and women 18 years of age or older * informed consent * regularly participating in helping the patient's daily life * for physicians : * identified as the patient's physician or family physician. * informed consent exclusion criteria: * persons with proven and significant cognitive impairment preventing the completion of semi-strutured interviews * person who does not speak french easily * generally, any person unlikely to cooperate in the study * adults under guardianship * refusal of relatives and/or general practitioner to participate to the study

Keywords: elderly people polymedication, ethics qualitative research
effects of pitavastatin on monocyte, endothelial dysfunction and hdl-c in subjects with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (capitain).


Eligibility criteria:
inclusion criteria: * patients with metabolic syndrome * patients with ldl-c \> 130mg/dl * eligible, able to participate and have given informed consent exclusion criteria: * body mass index \>35 kg/m2 * ldl-c \> 190mg/dl * fasting triglycerides \> 400 mg/dl * diabetes mellitus (fasting glucose \>7 mmol/l) or taking diabetic therapy * uncontrolled hypertension (systolic blood pressure \>= 140 mmhg or diastolic blood pressure \>= 90mmhg) * any conditions that cause secondary dyslipidaemia or increase the risk of statin therapy * alat and asat \>3 x ulrr * impaired renal function (serum creatinine \>1.5 x ulrr or egfr \<60 ml/min) * history of any muscle disease or unexplained elevation (\>3 x ulrr) of serum creatine kinase * evidence of symptomatic heart failure (nyha class iii or iv) * current or recent user of supplements or medications known to alter lipid metabolism
biliary cannulation during endoscopic retrograde cholangiopancreatography: precut versus conventional cannulation

Conditions: Jaundice, Obstructive

Summary: endoscopic sphincterotomy is now an established method for removal of common bile duct calculi and treatment of papillary stenosis, the sump syndrome and certain cases of ampullary carcinoma. it is also generally performed prior to biliary stent placement .anatomical variations, papillary stenosis, impacted stones, ampullary tumors, duodenal diverticula, and post-gastrojejunostomy states are some of the reasons behind difficult common bile duct (cbd) cannulations . in these situations, the success of cbd cannulation can be enhanced slightly by using the various accessories designed for this purpose.the aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication

the aim of this study is to prospectively compare conventional approach and needle knife fistulotomy in cannulation of ampulla of vater during endoscopic retrograde cholangiopancreatography regarding procedure-related complications as failure of cannulations, bleeding and perforation and postoperative complication this a prospective randomized controlled trial comparing two groups of patients who undergo endoscopic retrograde cholangiopancreatography for obstructive jaundice in gastrointestinal surgical center, mansoura university, egypt. from january 2014 to december 2014. group a consists of 50 patients who will undergo conventional approach and group b consists of 50 patients who undergo needle knife fistulotomy for cannulation of the ampulla of vater. randomization was done by paramedical personnel in the ercp unit by taking a number from an envelope. data will be registered in a specially prepared sheet for the purpose of the study. registered data will include: duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation. data also included postoperative hospital stay, serum amylase level and postoperative complications as pancreatitis, perforation, bleeding and cholecystitis. pancreatitis will be also graded according to its severity depending on the duration of hospital stay.

Eligibility criteria:
inclusion criteria: * all patients (no limit of age) required ercp calculator and malignant obstructive jaundice exclusion criteria: * unfit patients history of gastrectomy bleeding tendency larg tumour infiltrating the duodenum
men-10755 in treating adults with recurrent or refractory solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of men-10755 in treating adults who have recurrent or refractory solid tumors.

objectives: i. determine the maximum tolerated dose (mtd) of men-10755 in patients with recurrent or refractory adult solid tumors. ii. determine the qualitative and quantitative toxic effects of men-10755 and study the predictability, duration, intensity, onset, reversibility, and dose relationship of the toxic effects in these patients. iii. propose a safe dose for phase ii study. iv. assess the pharmacokinetics of men-10755 at different dose levels in these patients. v. document any possible antitumor activity of men-10755. outline: this is an open label, nonrandomized study. patients receive men-10755 as a single 15 minute intravenous infusion every 3 weeks, or upon recovery from toxicity. doses will be escalated in decreasing rates and depending on the clinical judgement of the investigator. the mtd is the dose at which dose limiting toxicity is observed in at least 2 of 6 patients at a given dose level. patients will be removed from the study if cardiac toxicity, disease progression, or renal, cardiac or pulmonary decline is present. projected accrual: at least 5 evaluable patients will be enrolled.

Eligibility criteria:
disease characteristics: see general eligibility criteria patient characteristics: age: 18 and over performance status: who 0-2 life expectancy: at least 3 months hematopoietic: anc at least 2,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl liver function tests no greater than 2 times upper limit of normal (uln) (unless related to liver metastases, then no greater than 5 times uln) renal: creatinine no greater than 1.4 mg/dl creatinine clearance at least 60 ml/min cardiovascular: lvef greater than 50% (measured by muga scan) other: not pregnant or nursing effective contraceptive method must be used during study no active bacterial infections no other nonmaliganant diseases no history of alcoholism or drug abuse no psychosis prior concurrent therapy: biologic therapy: no prior immunotherapy within 4 weeks of study concurrent use of growth factors is allowed in cases of febrile neutropenia (prophylactic use not allowed) chemotherapy: no prior chemotherapy within 4 weeks of study no prior nitrosoureas, mitomycin, or high dose carboplatin within 6 weeks of study endocrine therapy: no concurrent corticosteroids (unless approved by clinical investigator) radiotherapy: no prior radiotherapy within 4 weeks of study no prior extensive radiotherapy within 6 weeks of study surgery: not specified other: no prior experimental therapy no prior anthracyclines or anthracenediones

Keywords: unspecified adult solid tumor, protocol specific
study of patients with chronic hepatitis c infected with hcv lvl g1 and effect of peg-intron plus rebetol treatment (study p04793)

Conditions: Hepatitis C

Summary: to determine the relapse rate at 24 weeks follow up in hepatitis c virus genotype 1 low viral load (hcv lvl g1) patients treated for 24 weeks with peg intron and rebetol who are hepatitis c virus-ribonucleic acid (hcv-rna) negative at treatment week 4 and week 24. to determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

approximately 500 patients from about 100 sites to be identified as hcv lvl g1 patients

Eligibility criteria:
inclusion criteria: * willingness to participate * 18 years or older, either gender, any race * must have hepatitic c virus low viral load \[lcv lvl\] (positive, but \<600,000 iu/ml on the assay used by the individual study site. only hepatitis c virus-ribonucleic acid/quantitative polymerase chain reaction \[hcv-rna/qpcr\] assays with results in iu/ml are acceptable) and been diagnosed with genotype 1 * subject considered suitable for treatment per local label * investigator considers suitable and subject consents to be treated exclusion criteria: * does not show negative polymerase chain reaction \[pcr\] at week 4 * pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant * subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the summary of product characteristics \[smpc\]
acute kidney injury and recovery mode in pediatric liver transplantation

Conditions: Postoperative Acute Kidney Injury; Pediatric Liver Transplantation

Summary: acute kidney injury (aki) is a common complication after pediatric liver transplantation (plt), and renal impairment after lt has proven to be related with increased graft failure and mortality. the recovery mode of kidney injury after plt has not been systematically studied. therefore, in this study the investigators aimed to systematically evaluate prognosis of aki after plt, combine the recovery mode of aki with related risk factors, and establish a relationship between aki and ckd.


Eligibility criteria:
inclusion criteria: * patients who received a liver transplant for the first time. * patients who were younger than 18 years of age at the time of transplant. exclusion criteria: * patients with incomplete clinical data. * patients with less than 5 years of follow-up. * patients who have combined multiple solid organ transplants. * patients with preoperative renal impairment (egfr\<60ml/min/1.73 m2 or prior renal replacement therapy).
association study between vdr gene polymorphisms and risk and features of mg in han chinese population

Conditions: Myasthenia Gravis, Ocular; Gene Polymorphism

Summary: the vitamin d receptor gene (vdr) polymorphisms are the candidate genetic variants for susceptibility to autoimmune diseases. in the present study, the investigators aimed to assess the association between vdr polymorphisms and myasthenia gravis (mg) susceptibility and disease features in chinese han population.the patients with mg and healthy controls were genotyped for vdr rs1544410, rs2228570, rs731236, and rs7975232 polymorphisms using the improved multiple ligase detection reaction. information on age at onset, acetylcholine receptor antibody (achr-ab) and muscle-specific kinase antibody (musk-ab) status, thymus status, involved muscles at onset and osserman type at the maximum worsening during 2 years follow-up were obtained and used as the grouping basis of sub-classifications. intergroup comparisons of allele and genotype frequencies, haplotype distributions were performed between mg group and the control group, and between each pair of mg subgroups.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of myasthenia gravis. * han chinese population. * must be able to complete a 2-year follow-up visit. exclusion criteria: * clinical data collection can not be completed. * poor compliance.