Kornimate/medical-research-clean huggingface dataset:
drug eluting balloon venoplasty in av fistula stenosis

Conditions: Native Arteriovenous Fistula; Stenosis

Summary: deva is a single blinded, prospective, multicentre rct designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native av fistula stenosis.


Eligibility criteria:
inclusion criteria: * arteriovenous (av) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis. * fistula has been in use for at least 1 month and is \> 6 weeks old * brachiocephalic av fistula * brachiobasilic av fistula * radiocephalic av fistula (both proximal and distal) * participant \>/=18 yrs old * index lesion is less then the length of the deb, and the reference vessel diameter is appropriate for treatment with the size range of deb (4mm - 8mm diameter) * participant is able to give valid informed consent exclusion criteria: * allergy to iodinated intravenous contrast * allergy to paclitaxel * prosthetic grafts * long or tandem lesions that cannot be treated with a single deb * thrombosed arterio-venous fistulas * women who are breastfeeding, pregnant or intending to become pregnant * participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.
taf switch study in hepatitis b monoinfection

Conditions: Hepatitis B

Summary: to evaluate various markers of renal function and bone density after the switch to tenofovir alafenamide fumarate (taf) in chronic hepatitis b patients who are currently treated with tenofovir disoproxil fumarate (tdf) .

the investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among chb patients treated with more than 18 months of tdf to be 48%. renal tubular dysfunction associated with tdf may be reversible when tdf is discontinued 4. recently, taf 25 mg daily was shown to have comparable efficacy to tdf 300 mg with respect to viral suppression in both hbeag positive and hbeag negative chb patients (studies 110 and 108) at 48 weeks of therapy. as speculated, the systemic exposure to tenofovir was significantly less in patients exposed to taf compared to those on tdf with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving taf. notably, however, the question remains to what if any improvements may be seen in chb patients switched from tdf to taf. the investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 chb patients who are currently treated with tdf who are switched to taf.

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis b (who are either hbeag reactive or non-reactive) * treated with tdf with unquantifiable hepatitis b virus (hbv) dna by a sensitive polymerase chain reaction (pcr) assay for a minimum of 6 months * no prior nucleos(t)ide exposure prior to treatment with tdf * treatment with tdf for a minimum of 12 months exclusion criteria: * hiv infection
prevalence and severity of cramps in chronic kidney disease patients

Conditions: Cramps; Chronic Kidney Disease(CKD)

Summary: cramps are a frequent and severe complication in ckd patients. their characteristics : triggering factors, associated factors, are not well known. there is no recognized effective treatment. using a questionnaire, the investigators wish to determine prevalence, severity and associated factors of cramps in our ckd patients. better knowledge about cramps in ckd patients will allow to better support, and give a practical tool for treatment evaluation.

the investigator have elaborated a specific questionnaire for our ckd patient about cramps. this questionnaire concerns only cramps, regardless of the origin. the first question of the questionnaire will allow to evaluate the prevalence of cramps in our population of ckd patients. every patient will indicate his medical treatment and biological datas. only patients who will answer " yes " to the first question will complete the cramp score of gravity questionnaire. this score is composed of 4 items : frequency of crisis, there impact on sleep, there duration and there intesity patients will also indicate for how long time there have experimented cramps, the muscular zones involved, associated symptoms, triggering factors, and does something can help them for cramps (medicinal or non medicinal). the third part concerns there treatment and biological datas. finally there will complete the qol-sf12 questionnaire.

Eligibility criteria:
inclusion criteria: * voluntary patients with ckd iii to v (gfr\<60ml/mn/1,72m2), including dialysed patients (hemodialysis or peritoneal dialysis). * non opposed to participate to the research. exclusion criteria: * transplanted patient with functional graft.

Keywords: cramps chronic kidney disease pain
68ga-c1 pet/ ct imaging in clear cell renal cell carcinoma

Conditions: Carbonic Anhydrase IX; PET-CT; Clear Cell Renal Cell Carcinoma

Summary: the goal of this clinical trial is to evaluate the diagnostic value of caix protein specific probe 68ga-c1 in pet/ct imaging in clear cell renal cell carcinoma patients. it will also learn about the safety, tolerability and radiation dosimetry of 68ga-c1. researchers will compare the diagnostic value of 68ga-c1 pet/ct and 18f-fdg pet/ct in chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

carbonic anhydrase ix (caix) is a transmembrane protein which is highly expressed in approximately 95% of clear cell renal cell carcinomas, and it is closely related to tumor progression, patients prognosis and treatment response. here, we developed a caix specific small molecule probe 68ga-c1, which has shown a good diagnostic accuracy in pet/ct imaging in our preclinical mouse model of clear cell renal cell carcinoma. this enables high-contrast imaging of clear cell renal carcinoma, providing a new imaging method for the precise diagnosis of clear cell renal carcinoma. in this clinical trail, we will compare the diagnostic value of 68ga-c1 pet/ct and 18f-fdg pet/ct in chinese patients with indeterminate renal masses or confirmed clear cell renal cell carcinoma.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent； 2. age ≥18； 3. patients with confirmed or suspected clear cell renal cell carcinoma; 4. expected survival ≥6 months. exclusion criteria: 1. renal mass is known to be a metastasis of another primary tumor; 2. have other malignancies that require treatment; 3. have received chemotherapy, radiotherapy, or immunotherapy within 4 weeks; 4. renal insufficiency with glomerular filtration rate (gfr) ≤ 60 ml/min/1.73 m²; 5. pregnant and lactating women or female patients plan to become pregnant within 6 months; 6. uncontrolled psychiatric disorders; 7. vulnerable population (e.g., being in detention) or have a serious non-malignant disease (e.g., infectious disease, autoimmune disease, or metabolic disease).

Keywords: carbonic anhydrase ix 68ga-c1 pet-ct clear cell renal cell carcinoma
office-based radial expansion balloon dilation of the esophagus and trachea

Conditions: Tracheal Stenosis

Summary: retrospective chart review of ucdmc patients who have undergone esophageal or tracheal balloon dilation to record data including age, gender, diagnosis pre-and post-procedure eating assessment tool, esophagoscopy findings, tracheobronchoscopy findings, and pre-and post-procedure videofluoroscopic findings.

dilation of the esophagus is performed for strictures, webs, and rings at all levels of the esophagus. dilation of the trachea is performed for subglottic and tracheal stenosis. radial expansion balloons have been developed by bost scientific corporation for the purpose of dilating the esophagus and trachea through flexible esophagoscopies. these sequential controlled radial-expansion balloons can be introduced via a guide wire through the working channel of a 5.1 mm transnasal esophagoscope. traditionally, otolaryngologists have performed esophageal and tracheal dilation per oral under general anesthesia. this technique allows the procedure to be performed in the office, sparing the patient the risk of anesthetics. the purpose of this study is to review the ucdmc experience with esophageal and tracheal balloon dilation using the transnasal esophagoscope.

Eligibility criteria:
inclusion criteria: * patients who have undergone esophageal or tracheal balloon dilation since 1/1/05 * patients who underwent an attempted dilation since 1/1/05 exclusion criteria: * younger than 18 years of age * those who do not meet the inclusion criteria

Keywords: swallowing problems tracheal stenosis
effect of the erchonia® hls™ for the relief of tinnitus symptoms

Conditions: Tinnitus

Summary: this study is to see if applying red low-level laser light can help to reduce tinnitus symptoms

the purpose of this pilot study is to determine the effectiveness of the erchonia® hls™, manufactured by erchonia corporation (the company), in providing temporary relief of tinnitus symptoms in adults 18 years and older.

Eligibility criteria:
inclusion criteria: * subjective tinnitus * tonal tinnitus. * constant tinnitus on-going at least half the time over at least the past 6 months. * willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration. * willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation. * 18 years of age or older * primary language is english exclusion criteria: * objective tinnitus * atonal, pulsatile, intermittent, or occasional tinnitus * severe or profound hearing loss in one or both ears * current or prior surgically removed acoustic neuroma * consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days: nsaids (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates lasix and other "loop" diuretics "mycin" antibiotics such as vancomycin quinine and related drugs chemotherapy agents such as cis-platin * acute or chronic vertigo/dizziness * ménière's disease * prior stapendectomy * prior mastoidectomy * auditory nerve tumor (acoustic neuroma), current or surgically removed in the past * active infection/wound/external trauma to the areas to be treated with the laser * medical, physical or other contraindications for, or sensitivity to, light therapy * pregnant, breast feeding, or planning pregnancy prior to the end of study participation * developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
development of a therapeutic education program for patients operated for prostate cancer

Conditions: Prostate Cancer

Summary: the aim is to built a therapeutic education program for patients treated with radical prostatectomy in order to improve their sexuality. this study is carried out in two steps : * identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. patients from the urology department of the hospital center (ch) lyon sud - hospices civils de lyon (hcl) will be included * development of the program by a caregiver education expert (centre hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the education sciences.

8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (pde5 inhibitors, iic, vacuum), and patients adverse effects management. focus groups will be conduct to : * identify the representations associated with erectile dysfunction * identify the representations related to treatments for erectile dysfunction. * score patient knowledge about treatments and their managements. * identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments. * assessing the needs and expectations of patients

Eligibility criteria:
inclusion criteria: * patients followed in urology department lyon sud ch: * aged over 18 year * having a prostate cancer * treated with radical prostatectomy with or without conservation strips neuro vascular * more than 1 month postoperative * having a normal preoperative erectile function defined by a score iief ef ≥ 26. * and who signed the informed consent form for participation in the study exclusion criteria: * score preoperative iief ef \<26 * refusal of participation, signed consent major patients protected under guardianship. * patients unable to understand the course of the study * patient (s) with a documented history of cognitive or psychiatric disorders. * geographical remoteness of more than 100 kms.
investigation of the effects of different exercise approaches on clinical parameters in chronic obstructive pulmonary disease patients

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Summary: the beneficial effects of exercise training in individuals with chronic obstructive pulmonary disease (copd) are well known. standard exercise training includes structured aerobic exercise training and resistance exercise training programs applied to upper and lower extremity muscle groups. no study has been found in the literature that includes a trunk stabilization training program that includes muscles that provide whole body stabilization in copd patients.

the investigators aimed to determine the effects of an aerobic exercise training program, resistance exercise training, and an additional trunk stabilization training program in individuals with copd. individuals diagnosed with copd between the ages of 40-80 who applied to ankara etlik city hospital chest diseases polyclinic will be included in the study. data collection tools and exercise training programs will be made by the same researchers. a total of 44 copd patients, 22 in each group, will be included in the study. copd individuals who agree to participate in the study will be randomised electronically using a randomisation program and participants will be divided into two groups. group 1: aerobic exercise training and resistance exercise training and trunk stabilisation strength training group 2: aerobic exercise training, resistance exercise training and respiratory exercise training

Eligibility criteria:
inclusion criteria: * having a diagnosis of copd * being between the ages of 40-80 * being clinically stable (not having had an exacerbation in the last month) * being able to cooperate with the tests * not participating in any exercise training studies * being willing to participate in the study exclusion criteria: * having other lung or lung involvement diseases other than copd * having uncontrolled hypertension, arrhythmia and a history of myocardial infarction in the last month, unstable angina, advanced heart failure and other cardiac instability conditions * being hemodynamically unstable * being on noninvasive mechanical ventilation (nimv) and long-term oxygen therapy (ltot) * having a history of neuromuscular disease, scoliosis, chest wall surgery * being pregnant and having a malignancy * having an orthopedic or surgical problem that would prevent participation in tests and exercise training * not being willing to participate in the study

Keywords: copd exercise training trunk stabilisation muscle parameters
non invasive measurement of coagulation in term and preterm neonates

Conditions: Blood Coagulation Tests

Summary: the purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.

coagulation abnormalities among neonates aren't common - but can be life threatening. testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). non-invasive testing can help assess and treat term and preterm neonates at risk. recently, a non-invasive device to assess the blood coagulation status was developed - the thrombo-monitor (thm). the objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the thm reading to coagulation analysis from blood.

Eligibility criteria:
inclusion criteria: * newborn babies - term and preterm * written parental informed consent exclusion criteria: * congenital anomalies / chromosomal abnormalities

Keywords: coagulation tests neonates non invasive
dmt210 topical gel in the treatment of atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the objective of the study is to evaluate the safety and efficacy of dmt210 gel, 5% compared to vehicle control following 28 days of twice-daily topical application to selected target lesions in male and female patients with mild to moderate atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * male or female 12 years or older * patient has chronic, stable ad that has been present for at least 3 months with 5-35% (inclusive) bsa (body surface area) of ad involvement * patient has two analogous, target lesions; one lesion within each of the two treatment areas * patient is willing and able to comply with the protocol exclusion criteria: * patient has used topical therapies for ad within the treatment areas 2 weeks before baseline

Keywords: eczema dermatitis skin diseases skin diseases, genetic dermatitis, atopic skin diseases, eczematous hypersensitivity immune system diseases
connected health blood pressure monitoring in stroke and tia patients

Conditions: Stroke; Ischemic Attack, Transient

Summary: the goal of this pilot project is to assess adherence with home blood pressure monitoring in hypertensive patients with a history of cerebral infarction and to determine if a social incentive improves adherence with monitoring. enrolled subjects will all have a history of cerebral infarction and uncontrolled blood pressure, defined by sbp\>140 or dbp\>90 mm hg at the time of enrollment. to be eligible subjects will also be required to own a smart phone (ios or android operating system). after enrollment, patients will be given a home blood pressure cuff with instructions to monitor their bp twice daily for 90 days. subjects will be randomly assigned to a social incentive program, in which a social supporter receives updates via email and/or text message on the subject's adherence with bp monitoring and their average blood pressure. this study will provide important pilot data which will inform the design of future studies utilizing connected health and automated systems to improve home blood pressure monitoring and blood pressure control in patients with a history of stroke.


Eligibility criteria:
inclusion criteria: * adult, age ≥ 18 years * history of ischemic stroke or high risk tia (defined by abcd2 ≥ 4)between 2 weeks and 12 months prior to enrollment * hypertensive at time of enrollment, defined by sbp\>140 mm hg or dbp \>90 mm hg at the time of study screening * must own a smart phone capable of interacting with the connected blood pressure cuff (apple iphone 3gs or higher; android 4.0 or higher with bluetooth connectivity) * willingness and ability to sign informed consent by patient exclusion criteria: * moderate or severe disability, defined by modified rankin scale ≥ 3. * expected residence in a rehabilitation hospital, nursing facility or assisted living community during the study period. * upper arm circumference \ 17 inches * inability to monitor bp in both of the upper arms (i.e. history of bilateral radical mastectomy, bilateral severe subclavian stenosis, or bilateral arterial venous fistulas for dialysis). * blood pressure discrepancy between arms of \>10 mm hg. * inability to follow-up at 90 days and return bp monitor * active participation in another clinical trial * pregnant women
mid- and long-term outcomes of custom-made aortic devices

Conditions: Aortic Diseases; Thoracic Aortic Aneurysm

Summary: this study aims to evaluate mid- and long-term outcomes after thoracic endovascular aortic repair (tevar) with custom-made devices.


Eligibility criteria:
inclusion criteria: * thoracic aortic disease exclusion criteria: * urgent/emergent treatment
study of phosphate levels in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to investigate the ability of different doses of pa21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.


Eligibility criteria:
main inclusion criteria: * ≥ 18 years of age, * receiving stable maintenance hemodialysis 3 times a week * on restricted phosphate diet at screening and throughout study * receiving stable dose of phosphate binder for at least 1 month * serum phosphate levels \>1.78 mmol/l main exclusion criteria: * uncontrolled hyperphosphatemia * hypercalcemia at screening or during washout * serum calcium \< 1.9 mmol/l (\<7.6 mg/dl) * severe hyperparathyroidism (ipth levels \>600 ng/l) * pregnancy or lactation * iron deficiency anemia * history of hemochromatosis or ferritin \>800 mg/l, * hepatitis b, hepatitis c or other significant concurrent liver disorders * known positivity to hiv * use of oral iron preparations 1 month before screening, * serious medical condition or uncontrolled systemic disease

Keywords: hemodialysis