Kornimate/medical-research-clean huggingface dataset:
drug-eluting balloon in arteriovenous graft

Conditions: Kidney Failure, Chronic; Angioplasty; Dialysis

Summary: the investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (pta) with paclitaxel-coated balloon (pcb) at venous anastomotic stenosis of arteriovenous graft (avg) in patients with hemodialysis


Eligibility criteria:
inclusion criteria: 1. aged 18 to 90 years 2. patients under hemodialysis via prosthetic arteriovenous graft in the arm 3. vascular access was created for more than 30 days and used at least one successful session 4. clinical failure for hemodialysis due to higher venous pressure or lower arterial flow 5. angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into avg no more than 2cm and naive vein no more than 7 cm). there was no other obvious stenosis. 6. reference diameter of venous anastomosis within 7 mm exclusion criteria: 1. patient could not write informed consent 2. being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular 3. current or scheduled enrollment in other, conflicting studies. 4. acute thrombosis in the past 3 months 5. central venous stenosis 6. concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months 7. a blood coagulation disorder 8. sepsis or infected arteriovenous access graft 9. a contraindication to the use of contrast medium 10. pregnancy

Keywords: angioplasty drug eluting balloon arteriovenous graft
first in human, single ascending dose study

Conditions: Ulcerative Colitis

Summary: the goal of this study is to evaluate the safety and tolerability of single ascending oral doses of inv-101 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy, adult, male or female (of non-childbearing potential only), 19-55 years of age, inclusive, at the screening visit. * body mass index (bmi) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit. exclusion criteria: * mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study. * history or presence of clinically significant medical or psychiatric condition or disease in the opinion of the pi or designee.
a cross-sectional survey to evaluate diabetes management, control, complications, psychosocial aspects of patients with type 2 diabetes in sri lanka

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in sri lanka.


Eligibility criteria:
inclusion criteria: * people with type 2 diabetes mellitus (dm) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months * patients willing to sign informed consent form exclusion criteria: * previous participation in this study * unable to comply with protocol requirements * confirmed or suspected pregnancy
evaluating infrasonic hemodynography

Conditions: Aortic Stenosis; Mitral Regurgitation; Pulmonary Hypertension; Heart Failure, Systolic; Cardiovascular Diseases; Coronary Artery Disease

Summary: this comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.

this comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. the infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics.

Eligibility criteria:
inclusion criteria: * normal sinus rhythm * lv systolic function \>53% exclusion criteria: * 1. known history of carotid artery disease * 2. moderate or greater valvular disease in group 1 * 3. other implantable devices (pacemaker, icd, cardiomems, tens unit, continuous glucose monitors, etc) * 4. active arrhythmia * 5. reduced ejection fraction (\< 35%) other than group 4 * 6. hearing loss

Keywords: infrasonic hemodynography biomedical device
cholesterol-lowering effects of lupin protein

Conditions: Hypercholesterolemia

Summary: the objective of the study is to determine the efficacy of lupin protein drinks (lupinus angustifolius boregine) in humans. parameters concerning cardiovascular risk factors and the metabolism of proteins, lipids and cholesterol will be evaluated.

based on the preliminary finding that a daily dosage of 35 g lupin protein is capable to affect plasma lipids positively, the physiological effects of two different daily lupin protein dosages will be investigated in two separate study groups (group a: 25 g protein/day; group b: 40 g protein/day). both study groups undergo double-blinded and controlled study conditions in a cross-over design. in each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to one of two randomization groups: after a 1-week run-in period (baseline), half of the 35 participants of each study group will consume drinks with lupin protein in the respective amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive the analogue amount of milk protein as well incorporated in a drink serving as control. after a wash-out period of four weeks, the protein source will be crossed within the two study groups for a second intervention period of eight weeks.

Eligibility criteria:
inclusion criteria: * moderate hypercholesterolemia (total cholesterol \>5,2 mmol/l) * age: 18-80 years old exclusion criteria: * intake of lipid-lowering pharmaceuticals * allergy against legumes or milk protein * intolerance against milk * pregnancy, lactation * chronic bowel disease

Keywords: dietary protein lupin protein cholesterol metabolism protein metabolism hypercholesterolemia protein-enriched drinks
role of the sympathetic nervous system in rosacea

Conditions: Rosacea

Summary: rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million americans, from an unknown cause. many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. this project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea.


Eligibility criteria:
inclusion criteria: * otherwise healthy males and non-pregnant/non-lactating females with mild to moderate erythematotelangiectactic rosacea, as well as age-sex matched healthy control subjects. exclusion criteria: * neurological, cardiovascular, respiratory, metabolic, muscular, or other dermatological disorders * current history of alcohol and/or drug abuse * known allergies or hypersensitivities to medications/drugs that are used in the protocol * current smoking or regular smoking within the last 2 years * body mass index \> 35 kg/m2 * medications or supplements which are known to affect neural, cardiovascular, or muscular responses

Keywords: autonomic nervous system skin blood flow skin sympathetic nerve activity
cancer localization in the prostate with f-18 fluorocholine positron emission tomography

Conditions: Prostate Cancer

Summary: the purpose of this project is to develop and evaluate fluorine-18 (f-18) fluorocholine (fch) positron emission tomography (pet) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. the proposed technique works by measuring the tissue metabolism of fch, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. the project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. these men will undergo pre-operative pet scanning to measure f-18 fch uptake in anatomical sextants of the prostate gland. imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of f-18 fch pet for detecting cancerous prostate sextants.


Eligibility criteria:
inclusion criteria: * clinically organ confined prostate cancer electing radical prostatectomy exclusion criteria: * weight \> 300 lb
pubertal evolutionary profile of children monitored for fetal ovarian cyst

Conditions: Fetal Ovarian Cyst

Summary: this study is based on pubertal surveillance of fetal ovarian cysts (kof). fetal ovarian cysts (kof) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.

these cysts are functional in the vast majority of cases and are therefore likely to disappear spontaneously, but they may become complicated before regressing. apart from complication, the natural evolution of these cysts, which are said to be "simple" because they are liquid on ultrasound, is towards regression in the first months of neo-natal life. surveillance during the 1st year of life showed that simple cysts regressed during the 1st trimester. in the case of complicated cysts, oophorectomy was necessary in 9 cases. in the 1-year follow-up, the ovarian recovery rate was significantly different depending on the appearance of the cyst (p\<0.0001); 60 ovaries out of 89 homolateral to the cyst were follicular, of which 48/49 (98%) were carriers of fluid cysts and 12/40 (30%) were initially heterogeneous. the origin of these cysts is unknown, the ovary is again physiologically stimulated during the onset of puberty. no series in the literature gives the long-term ovarian prognosis for these patients. we wish to evaluate the pubertal evolutionary profile of patients followed at the university hospital for kof. the data collected concerning puberty (age of menses) will be examined in relation to the age of menses in the siblings and in the mother, as well as to the data in the literature on the age of the first menses in france.

Eligibility criteria:
inclusion criteria: * patients at least 8 years of age at the time of inclusion. * patients being followed for fetal ovarian cyst. * minor patients of whom at least one of the two holders of parental authority has given his or her non-opposition. * patients covered by a social security scheme. exclusion criteria: * patients less than 8 years of age at the time of inclusion * ovarian cysts outside the neonatal period * refusal to participate. * opposition to disclosure of neonatal data. * pregnant or nursing patient.

Keywords: child puberty
the influence of different fluid therapy measures on the postoperative outcome in fast track of colon cancer.（ftslapcc)

Conditions: Colon Carcinoma

Summary: to compare the influence of two different fluid administration strategies on the clinical efficacy of patients with colorectal carcinoma during the fast-track surgery.

patients that were diagnosed with colorectal carcinoma by the first hospital of jilin university and were scheduled to undergo the laparoscopic surgery were prospectively included and divided into the experimental group and the control group with the random number method. after surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h; patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to "total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost" until their intestinal function completely recovered. the blood volume change indicators (heart rate, mean arterial pressure, oxyhemoglobin saturation, inferior vena cava diameter /body surface area (vcd), intra-abdominal pressure, specific gravity of urine, bnp, etc.) and inflammation indicators (crp, il-6, tnf-a) of the two groups of patients were observed and a comparison was made of the recovery time of intestinal function, incidence of complications, hospitalization time after operation and hospitalization expenses of the two groups.

Eligibility criteria:
inclusion criteria: 1. the age of 18-70 years old 2. the pathological diagnosis of colon cancer patients 3. no surgical intervention. exclusion criteria: 1. patients with heart, lung, liver, renal function were significantly abnormal 2. body mass index kg \>35 / m2 3. pregnancy 4. sepsis or systemic inflammatory response syndrome patients. 5. patients with severe malnutrition.

Keywords: colon carcinoma liquid treatment fast-track surgery
safety and efficacy of talampanel in glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: the purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. this study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.


Eligibility criteria:
inclusion criteria: * patients must be 18 years of age * patients must have histologically confirmed supratentorial grade iv astrocytoma (glioblastoma multiforme) * patients must not have prior radiation therapy, chemotherapy (including gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. glucocorticoid therapy is allowed. * patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment. * patients must have a karnofsky performance of at least 60% or more. exclusion criteria: * patients with serious concurrent infection or medical illness. * patients receiving concurrent chemotherapeutics or investigational agents.
sulforaphane use to effect inflammatory and metabolic changes in virally suppressed hiv patients

Conditions: HIV Infections

Summary: assess the effects of sulforaphane supplementation in hiv patients that have achieved viral suppression.


Eligibility criteria:
inclusion criteria: * hiv patients on active treatment who have a suppressed viral load and have been virally suppressed for 6 months or more. * bmi increase of 10% or more since initiation of hiv treatment over a year period. * bmi equal to or greater than 30. * 18-85 years of age. exclusion criteria: * cancer * pregnancy or breastfeeding * intolerance to cruciferous vegetables * intolerance to sulforaphane * gluten intolerance * creatinine \> 1.3 mg/dl * gfr \< 60 * ast or alt \> 1.5 times upper limit of normal. * white cell count \< 2000 cells per ml. * hemoglobin \< 10.5 g/dl. * platelet count \< 140,000 per ml.
chemotherapy plus radiation therapy in treating patients with previously untreated thyroid cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated anaplastic thyroid cancer.

objectives: i. evaluate the activity of chemotherapy with hyperfractionated radiotherapy in terms of complete and overall response rate, time to progression, pattern of failure, incidence of second primary tumors, and overall survival in patients with previously untreated anaplastic thyroid cancer. outline: this is a multicenter study. patients receive oral hydroxyurea every 12 hours on days 0-5, fluorouracil iv and paclitaxel iv continuously over days 1-5, and hyperfractionated radiotherapy twice daily on days 1-5. patients receive filgrastim (g-csf) subcutaneously daily on days 6-12. treatment repeats every 2 weeks for 5 courses. following completion of concurrent chemoradiotherapy, patients with no prior initial modified neck dissection who have residual macroscopic nodal disease or initially staged nodal disease with no evidence of residual disease undergo neck dissection. patients with macroscopic residual disease at the primary site undergo complete excision of disease. patients with any progressive disease or recurrence of disease undergo conventional surgical management. patients are followed at 4-6 weeks, every 3 months for 1 year, and then annually thereafter. projected accrual: approximately 16-46 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed anaplastic thyroid cancer metastatic disease allowed patient characteristics: age: 15 to 80 performance status: karnofsky 60-100% life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: alkaline phosphatase no greater than 2 times normal transaminases no greater than 2 times normal renal: not specified prior concurrent therapy: prior simple excision (e.g., transoral laser excision) of the primary lesion allowed if organ function preserved prior modified neck dissection allowed

Keywords: anaplastic thyroid cancer
outcomes of clareon panoptix in patients with prior myopic refractive surgery

Conditions: Cataract

Summary: this study is a single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and clareon panoptix implantation. subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. clinical evaluations will include administration of the quvid and iolsat questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.


Eligibility criteria:
inclusion criteria: * adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery. * prior binocular myopic photorefractive keratectomy (prk) or myopic lasik. * patients who have regular corneal astigmatism less than or equal to 0.6 d and are candidates for the panoptix spherical iol. * patients who have regular corneal astigmatism and are candidates for panoptix toric iol t3 * postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement. exclusion criteria: * any ocular comorbidity that might hamper postoperative visual acuity: * corneal abnormality including corneal dystrophy, irregularity, and degeneration. * moderate or severe dry eyes that can't be relieved after treatment. * history of or current anterior and posterior inflammation of any etiology. * retinal pathology such as amd, diabetic retinopathy, vein occlusion, etc. * glaucoma of any kind. * pregnancy or lactation. * any ocular surgery other than corneal myopic refractive surgery (lasik and prk). * patients with physical or intellectual disability (e.g. down's syndrome, parkinson's disease, unable to fixate) * apple kappa/chord mu ≥ 0.6. * higher order corneal aberrations at pupil diameter of 4mm: \> 0.6 total rms, \> 0.3 coma, \> 0.3 trefoil (to exclude irregular corneas) * any patient requiring a limbal relaxing incision. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
evaluation of the prevalence of oculomotor disorders in patients with radiologically isolated syndrome

Conditions: Radiologically Isolated Syndrome (RIS); Multiple Sclerosis

Summary: this study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.


Eligibility criteria:
inclusion criteria: * the patient must have given his informed consent and signed the consent form. * the patient must be affiliated or beneficiary of a health insurance plan. * the patient is at least 18 years old (≥) and under 50 years old (≤). * patients with radiologically isolated syndrome according to the criteria of okuda et al. (2009) * diagnosis of a radiologically isolated syndrome confirmed by the national expert center of nice for less than 3 years. exclusion criteria: * the subject participates in another study. * the subject is in an exclusion period determined by a previous study. * the subject is under guardianship, curatorship or safeguard of justice. * the patient is pregnant or breastfeeding * the subject refuses to sign the consent. * it is not possible to give the subject informed information. * patient presenting a pathological neurological examination. * patient with visual acuity less than 5/10 or with ocular instability
patients preference for oral or i.v. therapy

Conditions: Colorectal Cancer

Summary: until recently, bolus 5-flourouracil (fu) + folinic acid (fa) has been considered the standard chemotherapy for patients with colorectal cancer. several studies have shown that capecitabine is as effective as mayo regimen. the nordic fu/fa schedule was developed to be an active and tolerable bolus regimen. the nordic regimen consists of a short (3 minutes) bolus injection of fu and 30 minutes later fa for 2 consecutive days each 2 weeks. in randomized studies efficacy is comparable to other fu/fa regimens. it is claimed that patients prefer oral therapy and in a randomized study comparing oral therapy (uft/fa) and bolus fu/fa (mayo) 84% preferred oral therapy. in the present randomized cross-over study patients were randomized for 3 courses of nordic fu/fa followed by 2 courses of capecitabine (or vice versa), and patients were asked for their preference.


Eligibility criteria:
inclusion criteria: * indication for treatment with a fu-regime * who performance status 0-1 * life expectancy \> 3 months * adequate haematological, renal and hepatic functions * adequate contraceptives * written informed consent exclusion criteria: * known cns-metastases * prior treatment with chemotherapy * pregnant or breast feeding women * current infection, unresolved bowel obstruction or subobstruction, uncontrolled crohn's disease or ulcerative colitis * other serious illness or medical conditions

Keywords: patients preference colorectal cancer capecitabine fluorouracil + folinic acid cross-over study