Kornimate/medical-research-clean huggingface dataset:
pilot study of slow release oral milrinone in patients with advanced heart failure

Conditions: Heart Failure

Summary: advanced heart failure (hf), ineffective pumping of the heart, is a common, life-threatening cardiovascular disorder, characterised by marked symptomatic limitation and frequent hospitalization. it is particularly prevalent in older individuals (up to 10% of the population) and it has become the most common cause for hospitalization in people \>65yrs. as such it is also one of the leading consumers of healthcare spending. recurrent hospitalization is frequently due in significant part to the lack of viable therapeutic options for severe hf. during hospital admission, medications through a drip to give through a vein (intravenous therapy), is required to improve heart pumping capacity (such as milrinone).they are frequently used and in many cases prolonged treatment periods of intravenous therapy are required. in a growing number of cases, there is a need to continue this treatment at home, however this is particularly costly and often complicated by intravenous line infection. as such there is an expanding need for therapeutic options in patients with advanced hf. over 20 years ago, studies of the potential utility of a rapid release form of oral milrinone were examined, however these studies demonstrated adverse effects due to its quick release. this study aims to determine the safety and tolerability of slow release oral milrinone in advanced hf patients with no further clinical option and to evaluate its effects on hf status.


Eligibility criteria:
inclusion criteria: * advanced hf (current inpatients) with no further clinical options as defined by treating cardiologist. * nyha iii-iv * lvef\<35% * recurrent hospitalization (\>/=3 admissions in the preceding 12 months) for hf * on optimal tolerated medical/device therapy. stable therapy for 48hrs. * age 18-85 yrs * provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements exclusion criteria: * hypotension (bpsys\<85) * unstable rhythm including frequent non-sustained ventricular tachycardia or poorly controlled atrial fibrillation (ventricular rate \>100). * severe renal impairment cr\>250umol/l or dialysis. * other life-threatening eg neoplastic, haematological, hepatic or pulmonary disease. * pregnancy or female with childbearing potential and inability to use contraception
effects of education with jigsaw technique on diabetic foot risk knowledge and self-efficacy in nursing students

Conditions: Nursing Education

Summary: the aim of this study is to evaluate the effects of education given with the jigsaw technique on the diabetic foot risk knowledge and self-efficacy in nursing students

one of the important roles of nurses, the 'educational role', aims to provide the necessary behaviors for the protection, development and maintenance of health through planned education given by the nurse to healthy/sick individuals and their relatives. the focus of patient education is to provide the individual with self-management through skill and behavioral change. the provision of knowledge and skills to nurses to fulfill the requirements of the educational role begins during the student period and continues. the development of knowledge and skills for the assessment of diabetic foot risk will affect the quality of care that nursing students will provide to their patients when they start their profession after graduation. in recent years, methods and tools that facilitate learning and positively affect learning outcomes have been frequently used in education processes in order to strengthen nursing education and train more equipped nurses before graduation. one of these methods, the jigsaw (collaborative learning) model, is used to improve learning outcomes. the jigsaw technique (jt) is used as a teaching technique in which each student creates pieces of an academic and educational puzzle, specializes in puzzle groups and teaches the subject they specialize in to other group members. when the literature is examined, there are a limited number of studies on the jigsaw technique in the education of health professionals and students, and no study showing its effect on diabetic foot risk assessment was found.

Eligibility criteria:
inclusion criteria: * agree to participate in the study exclusion criteria: * don't agree to participate in the study

Keywords: jigsaw technique diabetic foot assessment self-efficacy
an open enrollment study of factor xiii concentrate in subjects with congenital factor xiii deficiency

Conditions: Factor XIII Deficiency

Summary: congenital deficiency of factor xiii is an extremely rare inherited disorder associated with potentially life-threatening bleeding. factor xiii concentrate is given to patients whose blood is lacking factor xiii. factor xiii concentrate works by assisting blood in the usual clotting process, thereby preventing bleeding. in this study, patients will be treated with fxiii concentrate (human) and followed closely to determine that they receive the dose of fxiii concentrate (human) that will best minimize the chance of bruising and bleeding. the purpose of the study is to provide fxiii concentrate (human) to patients until the product becomes commercially available in the united states.


Eligibility criteria:
inclusion criteria: * written informed consent/assent for study participation obtained before undergoing any study specific procedures * diagnosed with congenital fxiii deficiency requiring prophylactic treatment * males and females of any age exclusion criteria: * diagnosis of acquired fxiii deficiency * administration of a fxiii-containing product, including blood transfusions or other blood products, within 3 weeks prior to the baseline/day 0 visit * any known congenital or acquired coagulation disorder other than congenital fxiii deficiency * use of any other imp within 4 weeks prior to baseline/day 0 visit * female subjects of childbearing potential not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study * suspected inability (e.g., language problems) or unwillingness to comply with study procedures or history of noncompliance * any laboratory finding or medical condition which, in the opinion of the investigator, would put the subject or subject's disease management at risk

Keywords: hereditary factor xiii deficiency factor xiii
a study of ly2090314 and chemotherapy in participants with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: purpose of this phase i/ii study is to test how well ly2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: * metastatic pancreatic cancer with metastases amenable to biopsy * willingness to provide tissue and blood samples for research purposes * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 exclusion criteria: * history of islet cell, acinar cell, or cystadenocarcinomas * prior cytotoxic chemotherapy for metastatic disease, except prior gemcitabine or folfirinox (5fu + leucovorin + irinotecan + oxaliplatin) * radiation therapy, immunotherapy or biologic therapy \<28 days prior to study entry
a prospective trial of the intelon boss(tm) system

Conditions: Cornea; Lens Diseases

Summary: a prospective, open-label, single-site clinical trial designed to evaluate the repeatability and reproducibility of biomechanical imaging by the boss device. subjects will undergo unilateral biomechanical mapping of the cornea and lens by three boss devices operated by three (3) different operators.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. availability, willingness and sufficient cognitive awareness to comply with the examination procedures and schedule 3. signed written informed consent exclusion criteria: 1. no light perception or low vision rendering the subject unable to fixate to keep gaze still enough to acquire images 2. presence of corneal opacity 3. presence of cortical cataracts visible in an undilated pupil 4. any systemic disease or disorder which would prohibit image acquisition (e.g., parkinson's disease).
comparison of characteristics of bronchoalveolar lavage dusting and of specific questionnary data in healthy volunteers and patients suffering from sarcoidosis

Conditions: Sarcoidosis

Summary: comparison of dusting rate of bronchoalveolar lavage in healthy volunteers and patients suffering from sarcoidosis. blind analysis of bronchoalveolar lavage with optical microscopy, transmission electron microscopy and microanalysis. for patients, comparison of bronchoalveolar lavage, pathological examination of biopsies (optical microscopy, transmission electron microscopy and microanalysis) and specific professional and environmental questionnary. healthy volunteers matched with patients regarding to age (every 10 years), sex and tobacco consumption (non-smoking, smoking less than 5 pack-year, smoking between 5 and 10 pack-year, smoking more than 10 pack-year)


Eligibility criteria:
inclusion criteria: * absence of respiratory and cardiac illness (healthy volunteers) * normal spirometry and chest x-ray (healthy volunteers) * absence of viral infection (b and c hepatitis, hiv) (healthy volunteers) * confirmation of sarcoidosis (endoscopic exam with bronchoalveolar lavage) (patients suffering from sarcoidosis) exclusion criteria: * pregnant women * lack of bronchoalveolar lavage (volume less than 20 ml)

Keywords: dust rate microscopic analysis
lllt and russian electrical stimulation in osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: objectives: to investigate the effect of low-level laser therapy (lllt) application combined with russian electrical stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee. design: randomized controlled double-blind study. setting: specialist rehabilitation services.

abstract objectives: to investigate the effect of low-level laser therapy (lllt) application combined with russian electrical stimulation on pain, mobility, functionality, range of motion, muscular strength, and activity in patients with osteoarthritis of the knee. design: randomized controlled double-blind study. setting: specialist rehabilitation services. participants: eighty participants with knee osteoarthritis were randomized. intervention: participants were randomized into four groups: group i (n=20; lllt over three weeks followed by an eight-week receiving russian electrical stimulation), group ii (n=20; placebo laser over three weeks followed by an eight-week receiving russian electrical stimulation), group iii (n=20; lllt over three weeks followed by an eight-week receiving lllt application combined with russian electrical stimulation), group iv (n=20; placebo laser over three weeks followed by an eight-week receiving placebo laser application combined with russian electrical stimulation). the groups treated with lllt received treatments with invisible infrared laser (904 nm, 3 joules/point). the placebo groups received identical treatment, but the infrared laser output was disabled. the sessions occurred three times a week. main outcome measures: the primary outcome was the change in knee pain and functionality (lequesne). secondary outcomes included change in mobility (8 meters and timed up and go test), range of motion (goniometer), muscular strength (dynamometer), activity (western ontario and mcmaster universities osteoarthritis questionnaire) and medication intake.

Eligibility criteria:
inclusion criteria: 1. levels 2-4 according to kellgren-lawrence grade 2. aged 50-75 years 3. both genders 4. have knee pain and functional disability for at least three months 5. according to the criteria of the american college for rheumatology. exclusion criteria: * cancer, diabetes, symptomatic hip osteoarthritis, or used antidepressants, anti-inflammatory medications or anxiolytics during six months prior to enrolment.

Keywords: low level laser therapy russian electrical stimulation
gynecare tvt secur for the management of stress urinary incontinence (sui)

Conditions: Stress Urinary Incontinence

Summary: this is a prospective, non-randomized, observational, multicentre (5 sites) study in which subjects that have surgically-correctable stress urinary incontinence undergo a tvt secur operative procedure. the study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires, intraoperative procedural data will be collected. postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals up to 24 months. the anatomic position of the device will be characterize by transvaginal ultrasound testing. to determine the rate and/or improvement rate of patients who have received the gynecare secur device after 12 months and after 24 months.


Eligibility criteria:
inclusion criteria: to be considered eligible to participate in this study, subjects must meet the following requirements: 1. subject has agreed to undergo surgical implantation of the tvt secur system 2. subject has the complaint of sui for at least 6 months prior to the preoperative evaluation visit. 3. subject has confirmed sui resulting from urethral hypermobility on cough stress testing. 4. subject has at least 4 gm of urine leakage on 1-hour pad testing during the preoperative screening visit. 5. subject is at least 18 years of age to maximum of 85 years of age 6. subject is willing and able to give written informed consent prior to any study related procedures. 7. subject is willing to return for follow-up evaluation and questionnaire completion at 4-6 weeks, and at 3, 6, 12 and 24 month follow-ups. 8. subject is willing to undergo transvaginal ultrasound evaluation at the 4 weeks and 12 month follow-up visit. exclusion criteria: subjects will not be eligible for entry into the study if they meet one of the following criteria: 1. subject is pregnant. 2. subject has had any previous synthetic sub-urethral sling procedure. 3. subject has current urinary tract or vaginal infections. 4. subject has blood coagulation disorders. 5. subject has a compromised immune system or any other conditions that would compromise healing. 6. subject has upper urinary tract obstruction. 7. subject is unwilling to provide written informed consent. 8. subject is unwilling or unable to return for evaluation at 4-6 weeks, and at 3, 6, 12, and 24 months. 9. subject has uncontrolled detrusor overactivity. 10. subject has pvr greater than 100 cc. 11. subject has peak flow rate less than 10 ml/sec. 12. subject has urethral diverticulum. 13. subject has significant pelvic organ prolapse (grade iii/iv) requiring surgical treatment. 14. subject has had radiation therapy to the pelvic area at any time. 15. subject has current or active history of pelvic cancer. 16. subject who in the opinion of the investigator is unable and/or unlikely to comprehend the nature, scope and possible consequences of the study and to follow the study procedures and instructions and complete all study related measurements.

Keywords: sui stress urinary incontinence patients with stress urinary incontinence
effect of acupuncture to endothelial dysfunction induced by ischemia-reperfusion injury

Conditions: Healthy

Summary: some studies suggest that acupuncture improve flow mediated dilation (fmd) that represents endothelial function, but no study has investigated whether acupuncture protects against ischemia and reperfusion (ir)-induced endothelial dysfunction in humans. this is a prospective crossover study clinical trial. in the first crossover study, 20 healthy nonsmoking volunteers (25 to 40 years old) will be randomly assigned to acupuncture or control. endothelium-dependent, fmd of the brachial artery will be measured before and after ir (15 minutes of ischemia at the level of the proximal upper arm followed by 15 minutes of reperfusion). acupuncture will be performed from 10 minute after ischemia till the end time of reperfusion for 20 minutes. in the second single arm study, 16 volunteers are administered oral 5mg glibenclamide two hours before ir injury (n=8) or selective cox-2 inhibitor celecoxib 200mg twice a day for 5 days to know what mechanism is responsible for acupuncture effect on ir injury. fmd measurements and acupuncture intervention during ir injury are same as above mentioned.


Eligibility criteria:
inclusion criteria: * healthy volunteer age 25 to 40 years * non-smoker exclusion criteria: * hypertension (\>140/90 mmhg), diabetes any cardiovascular disease kidney disease thyroid disease cerebrovascular disease liver disease (bilirubin level \>2 mg/dl) pregnancy body mass index \>25 kg/m2

Keywords: volunteer bmi(25 kg/m2)
safety study of lifitegrast to treat dry eye

Conditions: Dry Eye Disease

Summary: the purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered bid for approximately 1 year.


Eligibility criteria:
inclusion criteria: * willing and able to read, sign and date the informed consent and hipaa documents * willing and able to comply with all study procedures * be at least 18 years of age * patient-reported history of dry eye in both eyes * a negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period exclusion criteria: * any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy * unwilling to avoid wearing contact lenses for 24h prior to visit 1 and for some duration during the study * any blood donation or significant loss of blood within 56 days of visit 1 * any history of immunodeficiency disorder, positive hiv, hepatitis b, c, or evidence of acute active hepatitis a (anti-hav igm), or organ or bone marrow transplant. * use of any prohibited medications during the appropriate pre-study washout period and at any time during the study unless otherwise specified * any significant illness that could interfere with study parameters * history of laser-assisted in situ keratomileusis (lasik) or similar type of corneal refractive surgery within 12 months prior to visit 1, and/or any other ocular surgical procedure within 12 months prior to visit 1; or any scheduled ocular surgical procedure during the study period. * known history of alcohol and/or drug abuse * subjects with dry eye secondary to scarring or destruction of conjunctival goblet cells (as with vitamin a deficiency)
risk of hospitalized infections among patients with type 2 diabetes exposed to oral antidiabetic treatment

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare the incidence of hospitalizations for infections among patients with type 2 diabetes mellitus who are new initiators of saxagliptin and those who are new initiators of oral anti-diabetic drug (oads) in classes other than dpp4 inhibitors; and to compare the incidence of hospitalizations with infections associated with t-lymphocyte dysfunction (i.e., herpes zoster, tuberculosis, or non-tuberculous mycobacterial infections \[evaluated as a composite outcome\]) among patients with type 2 diabetes mellitus who are new initiators of saxagliptin and those who are new initiators of oads in classes other than dpp4 inhibitors.

prospectively designed retrospective database study. this study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice

Eligibility criteria:
inclusion criteria: * 18 years of age or older * newly prescribed saxagliptin \[or an oad in a class other than dipeptidyl peptidase-4 (dpp4) inhibitors\] * enrolled in the respective database for at least 180 days prior to the first prescription of new oad exclusion criteria: * patients identified with a diagnostic code for inpatient diagnostic code for any of the infections of interest within the 180-day baseline period * patients with dpp4 inhibitor exposure during the baseline period * patients currently using exenatide or insulin
the ohsu pregnancy exercise & nutrition (pen) program

Conditions: Gestational Diabetes

Summary: personal behaviors can influence development of gestational diabetes mellitus (gdm), a condition that can adversely affect the pregnant woman, her developing fetus and future events for both. to reduce gdm risk, we will develop and implement an in-person team and web-based nutrition and exercise program for women, beginning in their first trimester. a scripted, peer-led, 20-week educational program, tailored for pregnant women working in teams (5 women/team), will be developed and implemented among pregnant employees and/or their spouses. each weekly thirty minute session will focus on achieving 30-minutes of moderate daily physical activity with nutrition targets of five servings of fruits and vegetables, 3 servings of whole grains and lower fat food choices. diet, exercise and lab assessments will occur before enrollment during the first trimester, each subsequent trimester and 12 weeks after delivery. in addition to exercise and diet survey results, we will assess fasting glucose, insulin, hemoglobin a1c levels, pregnancy weight gain, blood pressure, lipid and lipoprotein levels, pedometer records, weekly accelerometer data, each trimester and at 12 weeks post delivery, as well as gestational birth age, apgar score, delivery mode and infant birth weight, and weekly health thermometer self-ratings during the assessment period.


Eligibility criteria:
inclusion criteria: healthy first trimester pregnant women - exclusion criteria: hypertension, diabetes, known cardiopulmonary disease; orthopedic problems or other conditions that would prevent regular physical activity. -

Keywords: gestational diabetes exercise diet fruits vegetables whole grains pregnancy weight
comparison of functional recovery after distal intra-articular radius fracture with a dorsal tilt treated with an anterior plate versus a posterior plate

Conditions: Distal Intra-articular Radius Fracture With a Dorsal Tilt

Summary: for les intra-articular fractures, plate osteosynthesis is the indicated technique. despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. indeed, this therapeutic option allows a more anatomical reduction and stable fixation. first-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. over the last ten years, a new generation of thinner anterior plates has reduced these complications. in the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. the hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.


Eligibility criteria:
inclusion criteria: * patients who have provided written informed consent * patients older than 45 years * patients presenting a closed intra-articular fracture of the distal radius with a dorsal tilt (stages b2, c1, c2 and c3) exclusion criteria: * adults under guardianship * patients without national health insurance cover * pregnant or breast-feeding women * patients presenting other injuries in the same upper limb * patients presenting injuries of the wrist or hand (scapholunate injury, fracture of the carpal bone or fingers) * pre-trauma paralysis of the limb * open fracture * fracture with palmer tilt or extra-articular