Kornimate/medical-research-clean huggingface dataset:
paclitaxel eluting stent or exercise for thigh atherosclerosis

Conditions: Peripheral Arterial Disease

Summary: this randomized clinical study is intended to evaluate the use of zilver ptx stents for treatment of thigh atherosclerosis. research question: is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, zilver-ptx, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.


Eligibility criteria:
inclusion criteria: * patient has signed and dated the informed consent. * patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria. * reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm. * taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, mri or cti), i.e. proximal cm of sfa must be open * patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion. * patient has symptoms of peripheral arterial disease classified as rutherford category 2 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (positive claudication questionnaire) * exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect. * patient has a resting abi \ 1.2) must have a tbi \<0.8. * patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months. exclusion criteria: * patient is pregnant, breast-feeding or under 18 years of age. * patient unable to understand and sign informed consent forms * patient is simultaneously participating in another investigational drug or device study. * patient has any planned surgical or interventional procedure within 30 days after the study procedure. * patient in whom antiplatelet and/or anticoagulant therapy is contraindicated. * patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol. * patient 2-3 patent crural vessel runoff with \<50% stenosis throughout its course. * activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and bmi \> 40 * other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia

Keywords: atherosclerosis intermittent claudication angioplasty
ctcs for high grade glioma

Conditions: Stage III and IV Glioma Patients

Summary: the purpose of this study is to identify and quantify circulating tumor markers, which are associated with the presence of tumors. the current imaging available does not allow specificity of tumor size as it relates to pseudoprogression (a temporary enlargement or "swelling" of the tumor after treatment before it shrinks). our hope is that ctcs will provide a more accurate description of tumor state for high grade glioma patients.


Eligibility criteria:
inclusion criteria: * patients with biopsy-proven high grade glioma who are undergoing definitive radiotherapy as a part of their treatment regimen or patients with radiographic appearance of high grade glioma * age 18 or older * signed informed consent exclusion criteria:
pilate mat exercise versus muscle energy technique on chronic non specific low back pain

Conditions: Chronic Non Specific Low Back Pain

Summary: to investigate the effect of pilat mat exercise versus met on chronic non specific lbp:randomized controlled trial

low back pain (lbp) affects almost everyone at least once per life. hence,it has been considered one of the most common musculoskeletal problems.the pilates method starts by strengthening the core, which is achieved by coordinating breathing with movement. muscle energy technique is an associate degree of osteopathic manipulation methodology. the muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce.pilate mat exercise and muscle energy technique play a major role in treatment of patients with chronic non specific lbp so this trial will be conducted to investigate the effect of pilat mat exercise versus met on chronic non specific lbp:

Eligibility criteria:
inclusion criteria: * seventyeight subjects will be selected from both genders, with age above 18 years. * normal body mass index (bmi) will be included. * participants diagnosed with chronic nonspecific lbp. exclusion criteria: * the participants will be excluded if they had one of the following criteria: * patient with previous back surgery, lumbar disc herniation, spinal deformities. * neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis. * history of cardiovascular disease, diabetes mellitus and rheumatoid arthritis * pregnant women and osteoprosis. * leg length discrepancy.

Keywords: lbp pilate mat exercise met
safety and efficacy study of iontophoresis and dexamethasone phosphate to treat anterior uveitis

Conditions: Uveitis, Anterior

Summary: the purpose of this study is to define a safe and effective dose of iontophoretic delivery of dexamethasone phosphate ophthalmic solution using the eyegate® ii drug delivery system in patients with non-infectious anterior segment uveitis.

this is a randomized, double-masked, parallel group, dose-comparison, exploratory study of four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in patients with non-infectious anterior segment uveitis. the current study will evaluate the safety, tolerability, and efficacy of this technology at the four dose levels to determine a safe effective dose appropriate for future trials.

Eligibility criteria:
inclusion criteria: • non-infectious anterior uveitis exclusion criteria: * uveitis of infectious etiology * previous anterior uveitis episode ≤ 4 weeks prior to baseline * intraocular pressure (iop) ≥ 25 mmhg at baseline, a history of glaucoma, and/or patients who require ocular anti-hypertensive medications * topical corticosteroid treatment in either eye \< 48 hours prior to baseline * oral corticosteroid or intraorbital corticosteroid treatment in either eye \< 2 weeks prior to baseline * active intermediate or posterior uveitis

Keywords: iontophoresis non-infectious acute anterior segment uveitis ophthalmology
apt001 plasma/no generator to treat diabetic foot ulcer in adults

Conditions: Foot Ulcer, Diabetic

Summary: this is a 10-week, randomized, controlled study to evaluate the efficacy and safety of the apt001 plasma and nitric oxide treatment in subjects with a diabetic foot ulcer.

approximately 80 subjects will be randomized by computer to receive equally either sham therapy or plasma / nitric oxide treatments topically. the nitric oxide / plasma treatment will be delivered from 11.5 to 15 centimeters from the wound surface for 10 seconds per cm2 of wound size. subjects will be evaluated for efficacy and safety on a regular basis with clinical observations. the wounds of both groups will be treated with sharp debridement as determined by the site investigator. a collagen dressing, a non-adherent dressing, and an absorptive dressing will be applied to the wound after either the study therapy or the sham therapy. for an initial safety evaluation in patients with dfu, the first ten patients randomized will be limited to wound size of 7 cm2 or less and their wounds will be assessed 2-4 days after each treatment session. following completion of the final assessment in these 10 patients, data will be submitted to fda for review and approval before opening the enrolment for the remaining patients.

Eligibility criteria:
inclusion criteria: * 19 to 80 years of age * type 1 or 2 diabetes with hemoglobin a1c less than 12% * abi ≥ 0.7, palpable pulses and/or biphasic waveform study with doppler * wound size ≥ 1cm2 and ≤ 30cm2 (the first 10 patients enrolled will be limited to a wound size of 7 cm2 or less) exclusion criteria: * have a significant concomitant illness that would adversely affect participation in the study or affect the healing of the wound * have a severe infection in the ulcer including the presence of an abscess, cellulitis extending \> 2 cm beyond the ulcer margin, or osteomyelitis * have involvement of deeper tissues including bone or tendon * be currently receiving steroid medications, chemotherapy, or other medications that might affect healing of the wound * have received topical or systemic antimicrobial therapy within 48 hours of screening * have a malignancy other than skin cancer currently being treated * have substance abuse issues within the 6 months prior to screening * is a woman who is pregnant or breast feeding * has been treated with another investigational product within 30 days of screening * has been treated with tissue engineered skin or a biological therapy within 30 days of screening
long-term study of safety and efficacy of roflumilast in japanese patients older than 40 years with chronic obstructive pulmonary disease (apta-2217-08)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of this long-term study is to investigate the effect of roflumilast (apta-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (copd) who completed the 24-week evaluation of study apta-2217-06. roflumilast will be administered orally once daily. the present study consists of a 28 weeks treatment period, and is an extension of the 24-week study apta-2217-06 (registered study). the study will provide further long-term safety and efficacy data of roflumilast.


Eligibility criteria:
main inclusion criteria: * patients with chronic obstructive pulmonary disease (copd) * written informed consent * patients who completed the 24-week evaluation of study apta-2217-06 main exclusion criteria: * if patients required hospitalization or received emergency care for copd exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day * patients with long-term oxygen therapy * serious diseases

Keywords: copd phosphodiesterase 4 inhibitor roflumilast
a new measurement of anseikonia tolerance

Conditions: Aniseikonia; Anisometropia and Aniseikonia

Summary: population 1: measure the effect of size glasses from1-9% on stereopsis population 2: measure the effect of size glasses from 1-9% on stereopsis in two settings: * before and after cataract surgery * after dilation of the eye

population 1: 21 eye healthy phakic individuals. measurements: baseline stereopsis and stereopsis after size glass (1-9%) is added in front of the right eye and in front og the left eye. this measurement provides details on how much size difference a person can endure without impairing stereopsis. population 2: 11 phakic eye healthy individuals awaiting cataract operation on both eyes. measurements are the same as population 1 but this study group is also measured after dilating the eyes. this is to see if accommodation affects the measurement. a postoperative measurement six weeks after cataract operation is also performed to examine if cataract operation affects the measurement.

Eligibility criteria:
inclusion criteria: * no previous eye history * cataract grade \<= 1 * visual acuity above 0.8 exclusion criteria: * lack of cooperation * amblyopia * axial anisometropia * ametropia
a study to evaluate further therapeutic strategies with guselkumab in participants with moderate-to-severe plaque-type psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to demonstrate that super-responders (sre; defined as psoriasis participants who receive on-label guselkumab treatment until week 20 and respond with a psoriasis area and severity index score (pasi) = 0 at weeks 20 and 28) maintain control of disease until week 68 with prolonged treatment intervals of 16 weeks (guselkumab 100 mg every 16 weeks).


Eligibility criteria:
inclusion criteria: * has a disease duration of plaque psoriasis of either less than or equal to (\ 2) years calculated from date at which first symptoms \[plaque\] were reported by subject to date of screening visit at screening; approximately 40 percentage (%) of participants must have a disease duration \<=2 years * has moderate-to-severe plaque-psoriasis defined by a psoriasis area and severity index (pasi) score \>10 or affected body surface area (bsa) \>10%) and additionally a dermatology life quality index (dlqi) score \>10 at baseline (week 0) * have no signs or symptoms suggestive of active tuberculosis (tb) upon medical history and/or physical examination * agrees not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug * agrees not to receive a bacille calmette-guerin (bcg) vaccination during the study, or within 12 months after the last administration of study drug exclusion criteria: * has previously received any therapeutic agent directly targeted to interleukin (il) -23 (including but not limited to guselkumab, tildrakizumab \[mk3222\], risankizumab \[bi-655066\]) * has received any systemic immunosuppressant (for example, methotrexate, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, tacrolimus, fumaric acid esters), or anakinra within 4 weeks of the first administration of study drug. * tests positive for hepatitis b virus (hbv) infection or who are seropositive for antibodies to hepatitis c virus (hcv), unless they have 2 negative hcv rna test results 6 months apart after completing antiviral treatment and prior to baseline and have a third negative hcv rna test result at baseline * has received natalizumab, belimumab, or agents that modulate b cells or t cells (e.g., rituximab, alemtuzumab, abatacept, or visilizumab) within 12 months of the first administration of study drug * has received any anti - tumor necrosis factor (tnf)-α biologic therapy within 3 months before the first administration of study drug
factor xiii activity in gastrointestinal bleedings

Conditions: Gastro Intestinal Bleeding

Summary: the aim of this retrospective study is to investigate the relationship between factor xiii activity and the outcome of gastrointestinal bleedings. since factor xiii is of great importance in haemostasis and plays a key role in stabilizing the fibrin clot, it can be assumed that a deficiency of factor xiii leads to an unfavorable course of gastrointestinal bleedings. our hypothesis is that early detection of such a deficiency can prevent a more severe course and that substitution of factor xiii contributes to faster cessation of bleeding, improves patient outcome and reduces the number of red cell concentrates required.


Eligibility criteria:
inclusion criteria: * age over 18 years * confirmed diagnosis of gastrointestinal bleeding * assessment of factor xiii activity during the gastrointestinal bleeding episode exclusion criteria: * age under 18 years * diagnosis of hemophilia a or b or other congenital coagulation disorders
circulating stem cells, sdf-1, hif-1 and sepsis's indices in emergency abdominal surgical patients

Conditions: Sepsis

Summary: septic shock is a systemic inflammatory response syndrome with acute circulatory failure secondary to a documented infection. it is the most feared complication in icu patients, with a 50% mortality rate. the study of stem cells and their experimental use in sepsis treatment is particularly relevant in the international scientific research, where italy plays an important role. in the vast and complex field of stem cell research, the primary aim of the current proposal is to evaluate the time course level of circulating endothelial progenitor stem cells cd34 + / cd133 + (epcs), and some factors epcs-related, such as hypoxia- inducible factor (hif- 1) and stromal derived factor-1 (sdf-1) in septic patients undergoing major abdominal surgery. secondary objective 2: to investigate the relationship between cd133/cd34, hif-1, sdf-1a and outcome of septic/septic shock patients treated with standard conventional therapy alone (ct) or with extracorporeal hemoperfusion therapy (hct).

primary objective: to determine the time course level of the circulating epc (cd133/cd34), sdf-1a, and hif-1 in septic patients undergoing major abdominal surgery. secondary objective 1: to investigate the relationship between these factors: cd133/cd34, hif-1 and sdf-1a. secondary objective 2: to investigate the relationship between cd133/cd34, hif-1, sdf-1° and outcomeof septic/septic shock patients treated with standard conventional therapy alone (ct) or with extracorporeal hemoperfusion therapy (hct). in this trial, we hypothesize that cd133/cd34, hif1 and sdf1a will increase in septic surgical patients as consequence of impaired tissue perfusion and cellular hypoxia. our hypothesis is based on the fact that the stimulation of factors hypoxia-related, as sdf-1a and hif-1 could be the primary step for bone marrow stem cells stimulation. furthermore, we assume that survivors septic patients will show higher levels of epc, hif-1 and sdf-1a. each day, the anesthesiologist of the operating room and the on-call anesthesiologist will alerts the principal investigator to a potential eligible patient. participants included in the trial will be divided into two groups: * c group: postoperative non septic patients in emergency surgical ward (es) (control group) * s group: postoperative septic shock patients in intensive care unit (icu) healthy volunteers (h group) will be recruited from among staff members of the university hospital of foggia the research study can provide useful parameters for early diagnostic and therapeutic interventions in sepsis which is the leading cause of death from infection, with an incidence of approximately 10% in icu postoperative patients according to recent epidemiologic studies.

Eligibility criteria:
inclusion criteria: caucasian, over 18 years of age exclusion criteria: when it is impossible to collect blood samples (organizational reasons or because of emergencies regarding the health of the patients),pregnant patients,organ transplantation, palliative care,metastatic cancer patients
use of ventavis in patients with postembolic residual pulmonary hypertension

Conditions: Residual Pulmonary Hypertension

Summary: to assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.


Eligibility criteria:
inclusion criteria: * patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation) * patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm hg exclusion criteria: * patient did not sign the informed consent. * mean pulmonary artery pressure after surgical treatment less than 25 mm hg * age above 75 years. * patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke. * severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months). * acute heart failure or chf iv in nyha. * severe arrhythmias. * pregnancy, lactation. * the presence of severe diseases of other organ systems that may result in death during the first year after surgery.
fnirs in pediatric hearing aids

Conditions: Hearing Loss

Summary: pilot phase. monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fnirs) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants. hemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (hbo) and deoxygenated hemoglobin (hbr) recorded by the fnirs. the use of the fnirs in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.


Eligibility criteria:
inclusion criteria: * group a: infants and toddlers 3-18 months of age who are normal hearing. * group b: infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional. * socially insured subject * parents or guardians who have given their consent to participate in the study exclusion criteria: * medical condition that does not allow for research compliance.

Keywords: nirs hearing aid pediatrics cochlear implant rehabilitation neuroimaging
effectiveness of curcuminoids in controlling postoperative pain following total laparoscopic hysterectomy

Conditions: Postoperative Care; Pain Management

Summary: total hysterectomy is one of the most common surgical procedures in gynecology. total laparoscopic hysterectomy (tlh) has several advantages over open surgery, such as better cosmetic outcomes, faster recovery, and an earlier return to normal activities and work, and has thus become the preferred approach nonetheless, postoperative pain (pp) remains an issue of concern. the reported incidence of pp after tlh ranges from 35 % to 63 %. the origin of pp after laparoscopy is multifactorial, arising from several perioperative factors, including pneumoperitoneum, stretching of the intraabdominal cavity, blood left in the abdomen, and dissection of the pelvic region. a prospective trial found more intense pain and greater analgesia requirement in the immediate postoperative period associated with laparoscopic surgery than with laparotomy. methods to decrease the severity of pp are required before tlh can be confidently recommended. curcumin has several benefits, which are endorsed by the world health organization (who). that is, it can be used to treat dyspepsia and peptic ulcer. moreover, it has anti-inflammatory and analgesic properties. most benefits are attributed to its anti-oxidant and anti-inflammatory effects. curcuminoid is the active ingredient of turmeric. curcuminoids are used in laparoscopic surgery because of their aforementioned benefits. further, the use of traditional medicine, which is low-cost and effective in improving postoperative pain due to abdominal diştention, is assessed.


Eligibility criteria:
inclusion criteria: -laparoscopic total hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, or sentinel lymphadenectomy candidates * they should be able to understand and sign an informed consent * they should be literate enough to understand the maintenance of a diary recording pain scores, qol-15 scores, and any adverse event exclusion criteria: * patients with any peripheral or central neuropathic pain * patients used to taking over-the-counter painkiller pills * patients with a history of alcohol intake/drug dependence * patients with a history of psychosis \*patients with chronic inflammatory diseases who cannot be taken off nonsteroidal anti-inflammatory drugs (nsaids)/painkillers * patients on immunosuppressive/cytotoxic/steroid therapy. \*patients with a known allergy to duloxetine