Kornimate/medical-research-clean huggingface dataset:
study of omni surgical system and istent for eyes with oag (trident)

Conditions: Glaucoma, Open-Angle

Summary: first, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the omni surgical system to implantation of the istent inject in lowering intraocular pressure (iop) in pseudophakic eyes with open angle glaucoma (oag), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the omni surgical system)to implantation of the istent inject in lowering iop in pseudophakic eyes with oag.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, 18 years or older 2. pseudophakic 3. diagnosis of open angle glaucoma (oag) 4. on 1-5 ocular hypotensive medications exclusion criteria: 1. any of the following prior treatments for glaucoma: * suprachoroidal stent (e.g. cypass, istent supra) * laser trabeculoplasty ≤ 8 weeks prior to baseline visit with a migs or other glaucoma device including but not limited to istent, istent inject, hydrus, cypass * trabeculectomy or other bleb forming procedure including xen, preserflo, express, glaucoma draining device/valve * prior canaloplasty, goniotomy, or trabeculotomy including procedures with gatt, kahook dual blade, itrack, trabectome * ciliary ablation procedures including endocyclophotocoagulation (ecp), cyclophotocoagulation (g probe), micropulse laser, or high intensity focused ultrasound (hifu) 2. any other form of glaucoma other than oag 3. concurrent ocular pathology or systemic medical condition which, in the investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet amd, corneal edema, fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to screening visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits). 4. women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
otivacto spain non interventional study

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a self-controlled study design enrolling consented copd patients who will be treated with spiolto® respimat® according to the approved smpc. patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.

purpose: study design:

Eligibility criteria:
inclusion criteria: 1. written informed consent prior to participation 2. female and male patients = or \> 40 years of age 3. patients diagnosed with chronic obstructive pulmonary disease (copd) and requiring long-acting dual bronchodilation (long-acting muscarinic antagonist (lama) + long-acting beta2 agonist (laba)) treatment according to approved spiolto® respimat® summary of product characteristics (smpc) and copd global initiative for chronic obstructive lung disease (gold) guideline recommendation exclusion criteria: 1. patients with contraindications according to spiolto® respimat® smpc 2. patients who have been treated with a laba/lama combination (free and fixed dose) in the previous 6 months 3. patients continuing long-acting beta2 agonist and inhalative corticosteroids (laba-ics) treatment should not be additionally treated with spiolto® respimat® in order to avoid a double dosing of long-acting beta2 agonists 4. patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. pregnancy and lactation 6. patients currently listed for lung transplantation 7. current participation in any clinical trial or any other non-interventional study of a drug or device
effects of vertebral derotation on pulmonary functions

Conditions: Adolescent Idiopathic Scoliosis; Scoliosis Idiopathic

Summary: this study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.

sixty patients from both sexes with idiopathic scoliosis underwent posterior correction (fusion). they were presented with idiopathic scoliosis for 6-12 month. their mean cobb's angle was measured in degrees and their mean angle of rotation was measured also in degrees. before participation all the patients were examined clinically by a chest physician to exclude any cardio pulmonary or vascular disorders which may alter the pulmonary functions. all of them did not receive any physical therapy program prior to the operation. patients were arranged randomly into two groups (1 and 2), each containing 30 patients. group 1 (drg) received posterior correction, vertebral derotation technique during posterior correction and pulmonary rehabilitation program while group 2 (ndrg) received posterior correction and the same rehabilitation program given to group 1.

Eligibility criteria:
inclusion criteria: * male patients suffering from adolescent idiopathic scoliosis. * participant age ranged from 12- 18 years old. * all patients had the same medical care. * participants have received a good explanation of the treatment and measurement device. * treatment was conducted surgical intervention. exclusion criteria: * instability of patient's medical condition. * presence of any diseases that could affect the study results. * participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.

Keywords: lung functions, vertebral derotation, chest intervention
safety and efficacy of saxagliptin for glycemic control in non-critically ill hospitalized patient

Conditions: Diabetes Mellitus

Summary: the purpose of this research study is to test the safety and efficacy of a drug called saxagliptin (onglyza) for treatment of type 2 diabetes in non-critically ill hospitalized patients who have an hba1c of 7.5 or lower, on 1 or no non-insulin agent at home, or an hba1c ≤7.0% on ≤ 2 non-insulin agents at home.

the current professional organization guidelines recommend insulin as the preferred treatment for hospitalized patients. it is recommended that most critically ill patients should receive insulin infusion therapy and non-critically ill patients should receive basal bolus insulin therapy in the hospital. the study will test the hypothesis that treatment with saxagliptin is non-inferior to treatment with basal bolus insulin in this group of patients during their hospital stay. the study will evaluate the effect of saxagliptin, a dpp4 inhibitor, on glycemic control in non-critically ill hospitalized patients with type 2 diabetes mellitus (t2dm) the primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. the study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as compared to the control group

Eligibility criteria:
inclusion criteria: * patients with t2dm and hba1c ≤7.5% on ≤1 non-insulin hypoglycemic agent or hba1c ≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a non-critical illness. * written informed consent. exclusion criteria: * admitted to or expected to require admission to icu * patients with a history of diabetic ketoacidosis or hyperosmolar state * hba1c \>7.5% at the time of admission or within 3 months before admission * insulin requiring before admission * unable to take oral food or medications * systemic steroid use * pregnancy or breastfeeding * women of child-bearing potential (wocbp) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 4 weeks after the last dose of study drug. * history of pancreatitis or active gallbladder disease * end stage renal disease on dialysis * hypersensitivity to saxagliptin or another contraindication to dpp4 inhibitors * subject unable to give informed consent
computer aided respiratory therapy based on audio and spirometry signals

Conditions: Respiratory Therapy

Summary: the purpose of the study is to collect data: audio in the form of respiratory sounds and instructions from the therapist, spirometry data during the execution of the therapy, physiological parameters, and patient information. with the help of this data, algorithms will be developed for the automatic detection, localization, and classification of respiratory sounds, linked to the respiratory cycle using spirometric signals.

the study is an interventional study. patients receive their standard respiratory physiotherapy, but in the mean time they are monitored with a stethoscope, spirometer and a wearable to measure physio-logical parameters. it has been chosen to intervene as little as possible in the therapy to measure the respiratory sounds and breathing of the patient as accurately as possible. by recording therapy sessions with 15 patients, we expect to register several hundred events of respiratory sounds. this provides a good foundation for training an algorithm to detect and classify respiratory sounds.

Eligibility criteria:
inclusion criteria: * the patient has a chronic or acute respiratory condition and may need oxygen therapy * the patient is minimally 12 years old exclusion criteria: * the patient is cognitively impaired. * the patient has an undrained pneumothorax. * the patient is experiencing an acute pulmonary hemorrhage. * the patient is having an asthma exacerbation. * the patient has an infection with burkholderia cepatia. * the patient is in isolation due to the risk of infection.

Keywords: spirometry respiratory sounds
capable for frail dually eligible older adults

Conditions: Muscle Weakness

Summary: the johns hopkins school of nursing offers this research study which aims to learn more about whether services that help with medications, muscle strengthening, pain management and changes to houses can help improve older adults' ability to, walk, and take care of themselves while saving costs by reducing hospitalizations and nursing home admissions.

* 65yrs or older * be able to stand (with or without assistance) * have some difficulty with getting dressed, or preparing food, bathing * receive a low monthly income * have no plans to move in the next year * not be receiving home nursing or other therapy right now

Eligibility criteria:
inclusion criteria: * 65 or older * cognitively intact (≥ 10 on brief interview of mental status) * difficulty with ≥ 2 iadls or ≥ 1 adl * ≤ 199% of federal poverty level exclusion criteria: * terminally ill --active cancer treatment * hospitalized \> 3 times in last 3 years * receiving home nursing, occupational therapy or physical therapy * don't have phone or do plan to move in less than a year

Keywords: medical costs improved iadls and/or adl's decreased nursing home admissions
validity and reliability of the turkish version of woos

Conditions: Evaluating the Validity and Reliability of the Turkish WOOS

Summary: various clinical scales are available to investigate shoulder diseases. some of them, culturally adapted to the turkish population. however, none of them are specific for osteoarthritis of the shoulder. thus, this study aimed to translate the woos index into turkish and investigate its psychometric properties in the turkish population.

purpose; the aim of this study is to adapt the western ontario osteoarthritis of the shoulder index (woos) specific to shoulder osteoarthritis, to turkish and evaluate its validity and reliability. methods; woos index was translated and culturally adapted to turkish, systematically. it was applied to 68 patients with osteoarthritis of the shoulder treated conservatively. the reliability of the scale was checked through internal consistency and test-retest methods. internal consistency was analyzed with cronbach's alpha value. test-retest reliability was assessed using an intraclass correlation coefficient with 25 patients. the western ontario rotator cuff (worc), the shoulder pain and disability index (spadi), and the society of american shoulder and elbow surgeons standardized shoulder assessment (ases) score were used to conduct concurrent validity.

Eligibility criteria:
inclusion criteria: * presence of the shoulder osteoarthritis, to be a native turkish speaker exclusion criteria: * illiteracy, cognitive impairment, presence of shoulder circumference fractures

Keywords: woos validation osteoarthritis shoulder turkish version
using us to evaluate aortic aneurysm size based on 3d co-registration to previous ct scan

Conditions: Aortic Aneurysm, Abdominal

Summary: examine a new method based on fusion between ultrasound (us) and previous ultrasound/computerized tomography(us/ct) studies to evaluate the size of abdominal aneurysm and measure the changes over time and following invasive repair procedure.

selection test for assessing aortic aneurysm is ct angio, it performed after injection of contrast material and allows a complete demonstration of the blood vessels. this test exposes the patient to ionizing radiation and the injection of iodine contrast medium. repeated tests pose a risk of developing a malignancy in the future due to the use of ionizing radiation and risk of renal impairment and allergic reactions due to the injection of contrast material. ultrasound is another test that enables the detection and evaluation of aortic aneurysm. patients with a known diagnosis of aortic aneurysm detected on ct are required to continuous monitoring in light of its growth over time and the risk of rupture. using co-registration over the us device will enable to conduct a us directed aorta examination, which uses the information produced from the ct as a "roadmap" for detection and localization of the aneurysm. that can theoretically improve detection capabilities and characteristics of the aneurysm and outcomes of the invasive treatment.

Eligibility criteria:
inclusion criteria: •patients with abdominal aortic aneurysm diagnosis in clinical follow-up or after an invasive procedure to fix it. exclusion criteria: * inability to perform ultrasound * pace maker * hemodynamic instability * inability to cooperate in us examination * pregnant women - does not undergo ct
addressing psychosocial comorbidities in hiv treatment and prevention

Conditions: Human Immunodeficiency Virus; Depression; Mental Health

Summary: project aproach is an open pilot trial of a cognitive behavioral therapy (cbt) for individuals with hiv with various psychological comorbidities, which the investigators call "syndemics". syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as hiv sexual transmission risk behavior and adherence to self care.


Eligibility criteria:
inclusion criteria: * hiv+ individuals * uncontrolled virus (plasma hiv rna concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (sti) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months. exclusion criteria: * unable or unwilling to provide informed consent * active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation * opinion of the pi that the participant would be at risk for harm to himself or others as a result of study participation, * under the age of 18 or over the age of 65, * current cbt for a psychiatric disorder, or a course of cbt in the past year.
evaluation of endorefix endovascular delivery system and staple

Conditions: AAA Graft Implant for Primary Aneurysm Treatment; AAA Graft Repair to Extend Life of Implant

Summary: this study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. a newly modified delivery system will provide endovascular access for implantation of a staple during endovascular graft procedures.


Eligibility criteria:
inclusion criteria: 1. male or female \>21 years of age 2. undergoing endovascular stent grafting for aaa repair 3. post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak. exclusion criteria: 1. pregnant 2. religious, cultural or other objection to the receipt of blood, or blood products. 3. unwilling to comply with follow-up schedule 4. unwillingness, or inability to provide informed consent to both trila and procedure 5. ruptured aneurysm 6. area where staple is to be placed has significant loose thrombus associated with it 7. acute or chronic aortic dissection or mycotoc aneurysm 8. allergy to device materials 9. allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine. 10. clinically and morbidly obese such that imaging would be severely adversely affected. 11. uncorrectable bleeding abnormality 12. inflammatory aneurysm 13. connective tissue disease (e.g., marfans syndrome, ehlers danlos syndrome) 14. patients with ptfe grafts 15. patients with investigational grafts (i.e., those grafts that are not fda approved)

Keywords: abdominal aortic aneurysm
bone marrow transplantation in treating patients with multiple myeloma, chronic phase chronic myelogenous leukemia, or agnogenic myeloid metaplasia

Conditions: Chronic Myeloproliferative Disorders; Leukemia; Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: bone marrow transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. purpose: phase ii trial to study the effectiveness of allogeneic bone marrow transplantation in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia, or agnogenic myeloid metaplasia.

objectives: * determine the efficacy of allogeneic bone marrow transplantation (bmt) following high-dose cyclophosphamide and total body irradiation in patients with multiple myeloma, agnogenic myeloid metaplasia, or chronic myelogenous leukemia in first or second chronic phase. * determine the efficacy of bmt following busulfan and cyclophosphamide in these patients. * determine the toxic effects of these preparative regimens in these patients. outline: patients are stratified by remission (first vs second vs third). patients who have not undergone prior radiotherapy receive cyclophosphamide iv on days -6 and -5 and then undergo total body irradiation twice a day on days -4 to -1. allogeneic bone marrow is infused on day 0. patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7 to -4 or -6 to -3 and cyclophosphamide iv over 2 hours on days -3 and -2. allogeneic bone marrow is infused on day 0. patients are followed at days 30 and 90, at 6 months, and then annually thereafter. projected accrual: a total of 20-30 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * cytologically proven disease of one of the following types with transfusion-dependent anemia or thrombocytopenia (less than 50,000/mm\^3): * multiple myeloma * agnogenic myeloid metaplasia * chronic myelogenous leukemia in first or second chronic phase * philadelphia chromosome with bcr gene rearrangement * suitable sibling bone marrow donor available patient characteristics: age: * 15 to physiologic 55 performance status: * ecog 0 or 1 life expectancy: * not specified hematopoietic: * see disease characteristics hepatic: * bilirubin no greater than 2.0 mg/dl * sgot less than 2 times normal * alkaline phosphatase less than 2 times normal renal: * creatinine less than 2 mg/dl cardiovascular: * ejection fraction normal by muga * no acute myocardial infarction within the past 6 months * no active angina pectoris * no active congestive heart failure pulmonary: * fev greater than 50% predicted * dlco at least 50% other: * hiv negative * no active infection * no concurrent organ damage or medical problems that would preclude therapy prior concurrent therapy: * not specified

Keywords: refractory multiple myeloma stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma chronic phase chronic myelogenous leukemia chronic idiopathic myelofibrosis philadelphia chromosome positive chronic myelogenous leukemia
pupillometry dynamic measures in patients without ocular or neurological disease

Conditions: Optic Neuritis

Summary: retrobulbar optic neuritis (norb) is the damage to the optic nerve caused by inflammation. it causes a rapidly progressive and painful visual loss, often among young subjects. diagnosis confirmation is important to start proper treatment, because a norb is often the first symptom of multiple sclerosis. this diagnosis, based on a set of arguments, is difficult to define by a non-expert ophthalmologist. the pupillary light reflex is a way to test the visual afferent pathways. if it is subject to a large inter-individual variability, the dynamics of the pupillary light reflex and its latency are more reproducible. an easy way to study the dynamics of the pupillary light reflex is to study the pupillary cycle time (pct). in the case of norb, elongation of the conduction in the visual afferent pathways related to demyelination plate increases the latency of the pupillary light reflex and decreases the frequency of the pct. our hypothesis is that pct dynamics measures would be a reliable indicator and easy to evaluate some pathologies affecting the integrity of the nerve. the validation of a decrease in the frequency of the pct in norb, compared to the frequency observed in subjects ophthalmological or neurological disease, could help developing methods to study the conduction of the visual pathways with portable devices used during the standard ophthalmologic consultation and quickly orientate patients to specialized centers.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * subject without known ocular or neurological disease * ametropia inferior to 3 diopters for spherical correction and inferior to 1.50 diopter for astigmatism correction * matched for age and sex with one of the 22 subjects of the patients' unilateral norb database exclusion criteria: * history of disease affecting pupillary motility * anisocoria * patient under legal protection * pregnant or breast feeding patient * patient's refusal to participate in the study * no medical insurance coverage

Keywords: pupillary light reflex multiple sclerosis
ct based definition of a tissue window for acute stroke thrombolysis

Conditions: Stroke

Summary: aim of this study is to define a ct-based "tissue window" for stroke thrombolysis. our primary hypothesis is that 1. patients with a "tissue window" (favourable non-contrast ct (ncct) scan and an intracranial occlusion on ct angiography (cta) or perfusion-ct-mismatch" (area of reduced cerebral blood flow (cbf) \> area of reduced cerebral blood volume (cbv)) represent a significant proportion (\> 20%)of acute stroke patients and therefore are an important target group for future interventional studies 2. patients with a "tissue window" suffer an unfavourable outcome (\> 50 % mrs =\>4 at 3 months)if the occluded artery was not recanalized.


Eligibility criteria:
inclusion criteria: * ischemic anterior circulation stroke * last seen normal \< 12 hours * stroke severity =\> 3 on the national institute of health stroke scale * multimodal ct stroke protocol performed * informed consent obtained exclusion criteria: * premorbid modified rankin scale score \> 3 * contraindications to contrast media application * pregnancy or breast feeding * subacute stroke \> 50 % of mca territory * ct evidence of non-vascular cause of stroke symptoms

Keywords: stroke, ischemic computed tomography thrombolysis