Kornimate/medical-research-clean huggingface dataset:
chronic total occlusion crossing with the wildcat catheter

Conditions: Peripheral Arterial Disease

Summary: this is a prospective, multi-center, non-randomized study of the wildcat catheter to cross a single femoropopliteal chronic total occlusion (cto). safety and efficacy will be evaluated during the index procedure through 30-day follow-up.

patients with a cto, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. following providing informed consent, the cto will be addressed by the wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the cto. data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.

Eligibility criteria:
inclusion criteria: 1. patient is willing and able to provide informed consent. 2. patient is willing and able to comply with the study protocol. 3. patient is \> 18 years old. 4. patient has peripheral arterial disease requiring revascularization as evidenced by contrast, ct or mr angiography. 5. patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate. 6. target femoropopliteal vessel is ≥ 3.0 mm in diameter. 7. patient has rutherford classification of 2-5. exclusion criteria: 1. patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated. 2. patient has a known sensitivity or allergy to anti-platelet medications. 3. patient is pregnant or lactating. 4. patient has a co-existing disease or medical condition contraindicating percutaneous intervention. 5. target vessel is severely calcified as evidenced by angiography. 6. target lesion is in a bypass graft. 7. target lesion is in a stent (i.e., in-stent restenosis). 8. patient has had a procedure on the target limb within 7 days. 9. patient has had a procedure on the target limb within the past 30 days and is unstable. 10. patient is simultaneously participating in an investigational device or drug study. 11. patient has a planned surgical or interventional procedure within 30 days after the study procedure.

Keywords: chronic total occlusions superficial femoral artery popliteal artery
hummingbird tts ear tube delivery study

Conditions: Otitis Media

Summary: the purpose of this study is to determine if the hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

the objective of this study is to evaluate the safety and performance of the tti device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.the trial will be a multi-site, prospective, treatment only study of the preceptis ear tube introducer . patients will already have a scheduled tympanostomy procedure. enrollment in the study at each site will begin after receipt of institutional review board (irb) approval. patients will be considered enrolled at the time the informed consent document is signed. a maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.

Eligibility criteria:
inclusion criteria: 1. scheduled to undergo tympanostomy tube insertion. 2. at least 6 months old. 3. subject is able and willing to comply with follow-up requirements. 4. signed informed consent, parental consent form, or child assent form as applicable. exclusion criteria: 1. any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy) 2. significantly atrophic tympanic membrane. 3. significantly atelectatic tympanic membrane. for example, the tympanic membrane is in contact with the promontory of the cochlea. 4. anatomy precludes sufficient visualization and access to the tympanic membrane.

Keywords: tympanostomy myringotomy otitis media ear tubes ear infection
the effect of probiotics on microbial translocation and inflammation in hiv-infected patients

Conditions: HIV

Summary: objective: in this study the investigators aim at investigating: 1. probiotics ability to modulate the microbiome and microbial translocation, 2. if probiotics affect the level of cholesterol, triglycerides as markers of cardiovascular risk factors and 3. if a reduction of microbial translocation is associated with a reduction of inflammation in the gastro-intestinal tract. design: the study is a prospective clinical intervention trial of 40 hiv-infected patients. method: the investigator will administer the bacteria lactobacillus rhamnosus in capsular form to each patient 2 times a day in 8 weeks. at baseline and at the 8th week of the intervention, the investigators will collect blood samples, feces samples and make a positron emission tomography-magnetic resonance scans.


Eligibility criteria:
inclusion criteria: * age over 18 * confirmed hiv * no hiv treatment * cluster of differentiation 4+ cell count over 350 exclusion criteria: * antibiotic or probiotic in last 2 month * drugs that influence gut motility * diabetes * inflammatory bowel disease * cancer * autoimmune diseases
the use of a silver containing dressing (acticoat) on wound complication rates post elective cesarean section

Conditions: Surgical Wound Infection

Summary: the purpose of this study is to determine the effect of a silver containing dressing (acticoat post-op) compared to a standard dressing (opsite postop) on post elective cesarean section wound complications in obese women (bmi \>35).

women scheduled for an elective cesarean section at term will be recruited to participate in this study. the investigators plan to recruit 100 women. baseline demographic information will be obtained at the pre-op visit. eligible subjects will be randomized to received a silver containing dressing (acticoat postop) or the standard dressing (opsite postop). a randomization table will be computer generated in blocks of 20. a sealed opaque envelope containing the assigned dressing will accompany the patient to the operating room. standard antibiotic prophylaxis will be provided prior to skin incision. a subcuticular suture will be used for skin closure. at the time of skin closure, the envelope will be opened and the assigned dressing will be applied. the dressing will only be changed if it is saturated. the dressing will be removed at the time of discharge from hospital. a questionnaire regarding wound complications will be completed at the time of discharge from hospital, at 2 weeks post-op and 6 weeks post-op.

Eligibility criteria:
inclusion criteria: * women scheduled for elective cesarean section * bmi \>35 at the pre-op visit * consent to participate exclusion criteria: * allergy to silver * immunocompromised (hiv/aids, on immunosuppressive medications)

Keywords: complications cesarean section wound infection (following delivery)
arb, acei, dri effects on covid-19 course disease

Conditions: Hypertension; COVID-19

Summary: it is supposed to monitor hypertensive patients who are infected or have clinical manifestations of covid-19 for 1 month after the onset of the disease. three groups will be considered: 1. receiving ace inhibitors 2. receiving arbs 3. receiving dir.

poem (patient-oriented evidence that matters) intervention is performed as an open prospective randomized two medical centres trial in subjects suffering from covid-19 who have been receiving iras, either acei, arb or dri as basic antihypertensive therapy. covid-19 is confirmed by a pcr test, the disease follow-up is divided into 2 periods: up to 12 weeks and up to 24 weeks. primary outcome measure: bp was known one week before covid-19 and is tested during the disease onset on weeks 2, 4, 12, 24. secondary outcome measures are clinical features. subanalysis in patients with ckd is additionally performed for those who have ckd.

Eligibility criteria:
inclusion criteria: * hypertensive person, stage 1-2 exclusion criteria: * hypertensive subjects, stage 3, hf (nyha) 3-4

Keywords: acei, arb, dri clinical features ckd
the effects of hot yoga on vascular function

Conditions: Hypertension; Elevated Blood Pressure

Summary: this study will examine the effects of a 12 week hot yoga intervention on vascular health in adults between the ages of 20 and 65. the investigators are seeking individuals with slightly elevated blood pressure and stage i hypertension who are not currently taking blood pressure medications or exercising regularly. participants will receive 12 weeks of free yoga for their participation.

this study will examine the effects of a 12 week hot yoga intervention on vascular health by assessing changes of pre-intervention and post-intervention measurements in ambulatory blood pressure, endothelial function, and arterial stiffness in adults between the ages of 20 and 65. the investigators are seeking individuals with elevated blood pressure and stage i hypertension who are not currently taking blood pressure medications or exercising regularly. participants will receive 12 weeks of free yoga for their participation.

Eligibility criteria:
inclusion criteria: * elevated blood pressure or stage i hypertension; * sedentary (not currently exercising regularly); * not currently taking blood pressure medications. exclusion criteria: * pregnancy; * renal disease; * prior heart attack; * known coronary artery disease; * history of stroke, * heart failure, cardiac arrhythmias or chronic obstructive pulmonary disease (copd); * recent chest pain; * heat intolerance; * body mass index of 40 or more.
efficacy of vildagliptin 100 mg as compared to placebo as add-on to metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: vildagliptin is an oral anti-diabetic agent. this is a 24-week study to assess the efficacy on hba1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.


Eligibility criteria:
inclusion criteria: * patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1 * body mass index in the range 22-40 * blood glucose criteria must be met exclusion criteria: * pregnancy or lactation * history of type 1 diabetes * evidence of significant diabetic complications other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hemoglobin a1c
a single preoperative dose of gabapentin to decreases postoperative pain in ambulatory anal surgeries

Conditions: Pain, Postoperative

Summary: single dose 600 mg gabapentin will be given preoperatively in anal surgeries

patients will be grouped into 2 groups of 25 patients each, the first group will receive 600 mg of gabapentin one hour before surgery and the second group will receive a placebo tablet. pain scores will be measured postoperatively

Eligibility criteria:
inclusion criteria: 1. asa physical status i or ii 2. aged from 18 to 65 years 3. scheduled for anal surgeries at minya university hospital exclusion criteria: 1. presence of contraindications to neuraxial anesthesia 2. presence of history of central nervous system or mental disorders, epilepsy, chronic pain, or drug abuse. 3. the use of neuropathic analgesic or antiepileptic drugs

Keywords: anal surgery, gabapentin, postoperative pain
can nephrocheck™ predict the reversibility of early, acute kidney injury during septic shock?

Conditions: Heading

Summary: patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (aki).

patients with septic shock in the intensive care unit have an elevated risk of developing acute kidney injury (aki). aki is an independent factor for mortality. interventions that limit the worsening of renal function might have an impact on the mortality rate in these patients. given the absence of validated pharmacological treatments for limiting the progression of aki or for accelerating recovery from aki, early intervention and the restoration of the glomerular filtration rate (gfr) in this context of hemodynamic change during the initial phase of septic shock might improve the patients' prognosis. one major challenge is therefore how to determine whether or not the aki is reversible. the best-studied biomarkers (ngal and kim 1) have little discriminant power in septic patients because of their poor specificity or unsuitable kinetics for very early diagnosis. the combination of urine assays for tissue inhibitor of metalloproteinase 2 (timp2) and insulin-like growth factor binding protein 7 (igfbp7) has shown good diagnostic performance for the very early detection of the risk of developing aki in the following 12 hrs. urine levels of these two markers specifically reflect damage to kidney tubules. moreover, the levels appear to be strongly correlated with the severity of tubule damage. thus, one can reasonably hypothesize that measurement of these markers in the very early stages of septic shock might determine the presence and severity of kidney tubule damage. a threshold (yet to be defined) would help to differentiate between (i) transient, non-severe injury and (ii) injury that is already too severe to be reversible.

Eligibility criteria:
inclusion criteria: * age 18 or over * septic shock (according to bone's criteria) within 4 hours of introduction of catecholamines * aki, characterized by a kdigo score ≥ 1 * social security coverage exclusion criteria: * aki requiring emergency rrt (in the critical care physician's opinion). * anuria * stage 4-5 chronic kidney failure with a gfr below 30 ml/min. * rapidly progressing renal disorders (glomerulonephritis, hus, blockage, etc.) * obstructive aki * probable glomerular damage (nephritic syndrome, nephrotic syndrome, chronic glomerulonephritis) * pregnancy or breastfeeding * legal guardianship or lack of social security coverage. * cardiocirculatory arrest * life expectancy \<48 hours. * child c cirrhosis * prior occurrence of aki during the current hospital stay * transplantation * subject participating in another study with an exclusion period ongoing at the time of the pre-inclusion

Keywords: nephrocheck™ acute kidney injury
effect of transauricular vagal stimulation on cardiac function after spinal cord injury

Conditions: Spinal Cord Injury (SCI)

Summary: the aim of this study is to investigate the effect of transauricular vagal nerve stimulation (tavns) on cardiac autonomic functions in patients with spinal cord injury (sci).

spinal cord injury impairs autonomic pathways and ultimately cardiovascular homeostasis. spinal cord injury affects the autonomic system, resulting in impaired cardiac autonomic functions. this study is designed to evaluate the effect of transauricular vagal nerve stimulation (tavns) on cardiac autonomic functions in patients with spinal cord injury.

Eligibility criteria:
inclusion criteria: 1. aged between 18-60 2. having a traumatic spinal cord injury 3. cervical spinal cord injury patients with a history of autonomic dysreflexia 4. at least 6 months after the injury 5. signing an informed consent form showing consent to participate in the study exclusion criteria: 1. having a cardiac or neural pacemaker 2. presence of pregnancy 3. clinical coronary artery disease confirmed by invasive or coronary computed tomographic angiography 4. history of acute coronary syndrome (unstable angina, myocardial infarction) 5. documented arrhythmia and/or use of antiarrhythmic drugs on ecg 6. diagnosis of hypertension and use of antihypertensive drugs 7. damaged skin lesion in the application area

Keywords: vagus nerve stimülation
metacognitive therapy for post-concussive symptoms after mild traumatic brain injury

Conditions: Brain Injuries; Post-Concussive Symptom; Post-Concussive Syndrome

Summary: the purpose of this open trial is to investigate the feasibility, acceptability, and effect of metacognitive therapy in patients with prolonged post-concussive symptoms after mild traumatic brain injury.


Eligibility criteria:
patients with prolonged recovery after mild tbi (gcs \>12) will be recruited to our study if they have post concussive symptoms \> 6 months after injury. patients will be recruited from an ongoing cohort study investigating mild and moderate tbi at st. olavs hospital and trondheim municipality emergency clinic, and in addition (as of october 2017) among tbi patients at st olavs hospital who were not included in the cohort study. inclusion criteria * aged ≥between 16 and \< 60 years * have sustained a traumatic brain injury exclusion criteria * severe tbi (gcs score 8 or less) * non fluency in norwegian * living outside of norway * major other trauma with high risk of disability lasting more than 3 months. * major incidental intracranial findings in acute mri e.g. cyst, tumor, malformation, infarctions. * severe psychiatric, neurological or medical disease, including: psychotic disorders, bipolar disorder, ongoing severe depressive episode * personality disorders affecting adherence to the research protocol * alcohol/drug abuse affecting adherence to the research protocol * mental retardation, autism or other severe developmental disorders * prior complicated mild, moderate or severe tbi * stroke or other acquired brain injuries * progressive neurological disorders (e.g. parkinson's disease, ms) * advanced cancer, heart- or respiratory disease or other somatic diseases that interfere with function. * major other trauma e.g. spinal cord injury in addition to exclusion criteria already employed in the cohort study, patients with co-occurring psychiatric disorders that necessitate referral to specific treatment according to existing guidelines will be excluded from the current intervention study.

Keywords: psychotherapy
effect of advanced hybrid closed loop system on adjunctive continuous glucose monitoring metrics

Conditions: Diabetes Mellitus, Type 1

Summary: type 1 diabetes mellitus (t1dm) is an autoimmune disease characterized by pancreatic beta cells destruction, resulting in insulin secretion deficit (1). insulin therapy is essential in the therapeutical management of subjects with t1dm (1). the diabetes complications and control trial (dcct) has showed that intensive insulin treatment was associated with a reduction in the onset of complications related to diabetes. in recent years, treatment of t1dm evolved rapidly because of the significant improvements in the use of technology (2). with the spread of continuous glucose monitoring (cgm) systems, standardized metrics, summarizing time spent within optimal glucose range (time in range - tir), time below target glucose range (tbr) and time above target glucose range (tar), have become commonly used metrics in clinical practice (3,4). furthermore, glucose management indicator (gmi) estimates glycated haemoglobin from the average glucose level of cgm readings for 14 days and coefficient of variation (cv) evaluates the amplitude of glucose excursions. advanced hybrid closed loop (ahcl) systems combine insulin pump infusion and real time cgm (rtcgm) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected and can administer automatic corrective boluses in case of hyperglycaemia (6). different algorithms, as model predictive control (mpc) or proportional-integral-derivative (pid), are used by different systems available on the market and are currently used in clinical practice. overall, ahcl are associated with improvement of glycated hemoglobin (hba1c) and tir opening to the possibility to gain even tighter glycemic control. the primary objective is therefore to evaluate the glycemic improvement expressed through adjunctive cgm metrics in subjects with t1dm 24 months after starting ahcl therapy


Eligibility criteria:
inclusion criteria: 1. informed consent signed before any activity related to the study 2. age ≥18 years, both sexes 3. start of ahcl for at least 6 months before enrollment (from 01/01/2021 to 31/12/2023). exclusion criteria: 1. diagnosis of type 2 diabetes mellitus or other forms of diabetes, such as metasteroid diabetes, secondary to pancreatectomy, related to pancreatitis or secondary to endocrinological disorders, gestational diabetes, maturity-onset diabetes of the young (mody).
efficacy of motor control and diathermy treatment in acute low back pain

Conditions: Low Back Pain

Summary: lumbar pain is considered one of the most frequent health problems faced by human populations on a global scale. this study will be carried out to evaluate the efficiency of motor control treatments combined with diathermy in patients diagnosed with acute lower back pain, focusing upon the potential for accelerated patient recuperation if both treatments are applied simultaneously and jointly.


Eligibility criteria:
inclusion criteria: * acute low back pain (no more of 4 weeks) * spanish speaker * between 18-65 years exclusion criteria: * patients in whom diathermy is a contraindicated therapy * pacemaker * pregnant * not intact skin * thrombophlebitis * hypotension * anticoagulated patient or with local surgical intervention

Keywords: capacitive resistive diathermy motor control
two intensities of transcranial direct current stimulation to improve consciousness in severely brain injured patients

Conditions: Disorder of Consciousness; Minimally Conscious State; Vegetative State; Cognitive Impairment

Summary: limited treatments are available to improve consciousness in severely brain injured patients. transcranial direct current stimulation (tdcs) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (mcs) patients, and in some vegetative state (vs) patients. however the optimal intensity of electrical current stimulation remains unknown. this study will test the effects of two intensities of tdcs stimulation (either 0.2ma or 2ma) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the coma recovery scale-revised (crs-r) scores -, as well as quantified eeg recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (mcs, vs, and conscious but cognitively disabled patients) of various etiologies.

this study will use a cross-over double-blind design with each patient receiving both current intensities in a randomized order during 4 weeks (2 weeks for each tdcs intensity, totalizing a number of 10x2 stimulation sessions of 20 minutes each).

Eligibility criteria:
inclusion criteria: * non communicative patients (including conscious patients but presenting with major fluctuations of vigilance and/or of cognitive abilities) * patients with stable clinical examination * age between 18 and 80 years * brain injury confirmed by cerebral imaging (mri or tdm) * disorder of consciousness diagnosed by crs-r (vs, mcs, exitmcs) exclusion criteria: * status epilepticus * severely neurodegenerative illnesses (alzheimer disease, lewy body dementia) * pregnancy * patients underage

Keywords: consciousness disorder of consciousness minimally conscious state vegetative state exit-mcs transcranial direct current stimulation (tdcs) crs-r eeg cognitive erps