Kornimate/medical-research-clean huggingface dataset:
best vcli registry

Conditions: Critical Limb Ischemia

Summary: for subjects with critical limb ischemia, identify patient, physician/hospital, and geographic factors associated with variations in treatment strategies; compare treatments and outcomes, including quality of life, cost and cost effectiveness, at 6, 12 months.

the study will be a prospective multicenter registry evaluating the real world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia. population: patients over age 18 presenting with critical limb ischemia after initial enrollment at 40 study sites throughout the us. participants will complete follow-up 6 months and 12 months via call center telephone calls. the study plan calls for enrollment of approximately 1,200 participants throughout the us that will then have 12 month followup that includes collection of medications, hospitalizations for collection of events.additionally, the best-cli trial will be gathering quality of life data and cost data using similar instruments, thus providing an opportunity for comparison between cost and quality of life analyses in a clinical trial versus in a real-world registry and collection of quality of life using validated instruments: eq-5d, vasqol, sf-12.and bill review to determine economic impact of disease.

Eligibility criteria:
inclusion criteria: * male or female * age 18 years or older * infrainguinal peripheral artery disease (occlusive disease of the arteries below the inguinal ligament) * critical limb ischemia, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with rutherford categories 4-6 * documented consideration for enrollment in the best-cli trial with documented failure to meet inclusion / exclusion criteria. phase ll after best cli official enrollment ends, this inclusion criteria will be removed. * willingness to comply with vcli protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent. exclusion criteria: * presence of a popliteal aneurysm (\> 2 cm) in the index limb * life expectancy of less than 2 years due to reasons other than peripheral artery disease * active vasculitis, buerger's disease, or acute limb-threatening ischemia * current chemotherapy or radiation therapy * pregnancy or lactation * administration of an investigational drug for peripheral artery disease within 30 days of randomization * participation in a clinical trial (except observational studies) within the previous 30 days * prior enrollment or randomization into the best-cli trial
condensed percutaneous tibial nerve stimulation (ptns) protocol

Conditions: Overactive Bladder Syndrome

Summary: the purpose of this study is to understand how the frequency of ptns sessions impacts their efficacy in the treatment of over active bladder syndrome.

this study aims to evaluate the impact of the periodicity of the ptns treatments on the efficacy of treating patients with oab. we will compare the efficacy of a condensed (twice weekly) protocol to the standard (once per week) protocol of ptns therapy. objective #1 (6-wk cp vs. 12-wk sp) is to show that 6 weeks of the condensed protocol (cp) will yield a higher efficacy compared to the standard 12-week protocol (sp). if this 6-week cp is proven effective, candidates for ptns treatment could potentially experience symptom relief in half the time as the current standard of care, improving their quality of life quicker. objective #2 (12-wk cp vs. 12-wk sp) is to show that 12 weeks of the cp will have a higher efficacy compared to the 12-week sp. if the superiority of this 12-week cp is proven, it could be beneficial in treating patients with refractory oab.

Eligibility criteria:
inclusion criteria: * women and men (18 years of age and older) with overactive bladder syndrome, who are interested in receiving ptns treatment. exclusion criteria: * patients with anatomical limitations preventing successful placement of the electrode, medical disorders precluding stimulation (bleeding disorders, cardiac pacemakers, peripheral vascular disease or ulcers, or lower leg cellulitis). * pregnant women or women who are planning to become pregnant during the course of the study.

Keywords: overactive bladder syndrome percutaneous tibial nerve stimulation
the efficacy and safety of 2.5 mg chlorhexidine gluconate chip (periochip®) in frequent treatment versus routine treatment in therapy of adult chronic periodontitis

Conditions: Generalized Adult Periodontitis

Summary: the purpose of this study is to assess the efficacy and the safety of chlorhexidine gluconate chip (periochip®) in frequent treatment versus routine treatment in therapy of adult chronic periodontitis.


Eligibility criteria:
inclusion criteria: 1. signed and dated informed consent form. 2. good general health. 3. male or female patients aged \>21 years old. 4. availability for the 25 week duration of the study. 5. chronic periodontal disease on natural teeth 6. females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study. exclusion criteria: 1. oral health or factor that may influence the outcome of the study. 2. history of allergy to chlorhexidine . 3. patient uses chlorhexidine oral rinses/mouthwashes on a regular basis. 4. patients treated with medications that may influence the outcome of the study. 5. presence of any of the following conditions: type 1 diabetes, un-controlled type ii diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies. 6. the presence of any medical or psychiatric condition or any other condition that, in the opinion of the investigator, could affect the successful participation of the patient in the study. 7. patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
epidemiology and prevention of methicillin resistant staphylococcus aureus (mrsa) transmission in the community

Conditions: MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Summary: the overall goal of this project is to elucidate the epidemiology of mrsa transmission in the community and test an intervention to prevent mrsa transmission in this setting.

the overall goals of this project are to: 1. to investigate the determinants of and evaluate potential interventions to reduce the spread of methicillin resistant staphylococcus aureus (mrsa) infections in community settings in order to reduce the burden of this illness in the state of pennsylvania. this objective has the following specific aims: * to identify host, microbiological and environmental risk factors for prolonged mrsa colonization, mrsa transmission and clinical mrsa infection among patients with mrsa skin and soft tissue infections (sstis) and their household contacts and to use stochastic agent-based modeling methods to quantify secondary spread of co-mrsa in households. * to evaluate the impact of a decolonization intervention on mrsa infections in the household. * to identify immunological mechanisms underlying the ability of streptococcus pneumoniae colonization to inhibit mrsa colonization, transmission and infection in order to identify potential future immunological targets for interventions. 2. to foster multi-disciplinary and cross-institutional collaborations and develop the infrastructure for a center of excellence focused on antimicrobial drug resistance research, with the capacity for activities linking basic science, epidemiological and clinical intervention studies 3. to enhance opportunities for basic and clinical research training for undergraduate and graduate students, particularly from underrepresented minorities, in order to increase the pipeline of future biomedical scientists and clinical investigators

Eligibility criteria:
inclusion criteria: * all members of a household in which the index case is treated for a skin or soft tissue infection due to mrsa. all household members must agree to participate in order for the household to be enrolled exclusion criteria: * prior mrsa within past 6 months in the index case; age less than 6 months.

Keywords: mrsa; household; infection; colonization
effect of first rib mobilization with balloon breathing exercises

Conditions: Neck Pain

Summary: as non specific chronic neck pain is effecting quality of life in many ways, there are many studies evaluating the methods to treat that problem. this study aims to determine effect of first rib mobilization with balloon breathing exercises in non specific chronic neck pain. patients would be divided into two groups and both received conventional treatment. group a got conventional treatment only but group b got 1st rib mobilization with balloon breathing exercises in addition.

nonspecific chronic neck pain (nscnp) is defined as neck pain persisting for longer than 12 weeks or after the healing period or recurring neck pain that intermittently affects an individual over a long time. due to current life style, 22 to 70% of the population is expected to feel neck pain somewhere in their lives. people with non-specific chronic neck pain (nscnp) present with local hyperalgesia, impaired conditioned pain modulation, low quality of life, and psychological disruptions (fear of movement, depressive symptoms, pain catastrophizing) a systematic review and meta-analysis on respiratory dysfunction in patients with chronic neck pain reports that, patients with chronic neck pain have reduced respiratory muscle strength and pulmonary function compared with asymptomatic individuals, and this difference could be clinically meaningful. as previous studies provides evidence about effect of mwm on non specific chronic neck pain and also states relation of breathing dysfunction in nscnp so we aim to determine effect of first rib mobilization with balloon breathing exercise in addition to conventional treatment in non specific chronic neck pain. patients would be divided into two groups and both received conventional treatment. group a got conventional treatment only but group b got 1st rib mobilization with balloon breathing exercises in addition.

Eligibility criteria:
inclusion criteria: * age group 18-45 years * gender: male, female * patients with non-specific chronic neck pain referred by physician or orthopedic surgeon * computer users, mobile users and those with routine of prolonged sitting exclusion criteria: * any h/o neurological or vestibular disorders. * any h/o cervical trauma or surgery * any history of physiotherapy treatment for the cervical region within the previous three months * cardiac or respiratory insufficiency * pregnancy * neoplasm
non-invasive diagnosis of coronary artery stenoses by doppler echocardiography

Conditions: Stable Angina Pectoris; Unstable Angina Pectoris; Acute Myocardial Infarction

Summary: non-invasive evaluation of patients with stable angina and unstable coronary syndromes with transthoracic doppler echocardiography to evaluate presence of significant coronary stenoses. blinded evaluation and comparison with coronary angiography: presence and location of stenoses, and head to head comparison of clinical value and patient classification.

transthoracic doppler echocardiographic evaluation with extensive evaluation of coronary stenoses in all 3 main branches using colour flow, pulsed doppler and coronary flow velocity reserve (cfvr)after pharmacologic stress with adenosin in the area of lad and rdp. blinded evaluation of doppler results and coronary angiography regarding the other examination modality. coronary angiography diagnostic "gold standard". only stable and unstable patients otherwise scheduled for angiography on clinical reasons will be examined and included in the study. added january 2007 after ethics committee approval: comparison of cfvr with invasive fractional flow reserve (ffr) in selected subset of patients.

Eligibility criteria:
inclusion criteria: * unstable angina or acute myocardial infarction, or stable angina pectoris and * scheduled for coronary angiography on accepted clinical reasons exclusion criteria: * past coronary artery grafting

Keywords: doppler echocardiography coronary stenosis coronary angiography
the patient enablement instrument for back pain turkish version, validity and reliability study

Conditions: Low Back Pain

Summary: most people experience low back pain at some point in their lives, and most low back pain is classified as nonspecific because the factor causing the pain cannot be identified. current guidelines recommend self-management interventions for the management of nonspecific low back pain. the most commonly used assessment measures measure pain, disability, and quality of life. however, it is important to evaluate patients' ability to manage their nonspecific lbp-specific disease. in 1997, howie and colleagues introduced the concept of enablement, which represents patients' enablement, understanding of, and ability to cope with their health and illness. they developed the "the patient enablement instrument" to measure patient competence based on the theory that if patients' competence increases, other important outcomes will improve. the patient enablement instrument has since been translated into many languages and has generally demonstrated moderate to good validity and reliability. however, there are limitations to using the patient enablement instrument as an outcome measure. inspired by the patient enablement instrument, researchers from denmark and sweden developed the patient enablement instrument for back pain , which could potentially be used as an outcome measure for interventions aimed at improving self-management in people seeking treatment for low back pain. in 2021, nielsen et al. the validity and reliability of the scale was determined by and its use was recommended in the population experiencing low back pain. the aim of our study is to culturally adapt the patient enablement instrument for back pain into turkish and to examine its validity and reliability.


Eligibility criteria:
inclusion criteria: * having low back pain for at least 3 months exclusion criteria: * having acute pain
a resiliency and tic intervention for pmhnp specialty dnp students

Conditions: Stress; Trauma

Summary: the goal of this observational study is to explore the impact of a resiliency and trauma informed care educational intervention for psychiatric mental health nurse practitioner (pmhnp) students at the university of arizona college of nursing during the final, clinical year of the program. specifically, the investigators will examine if the educational intervention is feasible, acceptable and helpful to students, and can decrease burnout and increase resiliency.

students in the doctor of nursing practice (dnp) and certificate programs during their final, clinical year of the program will be asked to complete anonymous online surveys before each semester (spring, summer, and fall) that measure levels of burnout, resiliency, adverse childhood experiences (aces), perceived stress, and knowledge related to trauma-informed care principles and ways to promote their resiliency. students in the psychiatric mental health nurse practitioner (pmhnp) specialty will receive an educational intervention related to trauma-informed care and resiliency during an in-person clinical immersion in january, may, and august 2023; after each session, they will be asked to complete an anonymous online post-intervention survey. each survey includes a disclosure statement and list of university and national mental health resources in case participants experience any emotional distress related to the topics/questions related to the survey.

Eligibility criteria:
inclusion criteria: * doctor of nursing practice (dnp) and post-masters certificate students at the university of arizona college of nursing in the final, clinical year of their program. exclusion criteria: * none.

Keywords: graduate nursing students resiliency trauma informed care
evaluation of the effect of human recombinant growth hormone in patients with advanced heart failure

Conditions: Heart Failure

Summary: prospective randomized, placebo controlled, clinical trial to evaluate the effect of human growth hormone supplementation compared with placebo to patients with severe heart failure for a duration of 6 months on exercise capacity, heart function and quality of life


Eligibility criteria:
inclusion criteria: individuals with a diagnosis of chf, nyha functional class iii or iv symptoms, an ef of \< 35 % estimated on radionuclide angiography (rna) or 2d echo within the last 6 months, and a 6 minute walk distance of less than 400 meters. patients must be stabilized on "chf" therapy at the time of randomization. exclusion criteria: 1. exercise limited by claudication, angina, neurological, pulmonary (fev1 \< 50%; fvc \< 50%), or musculoskeletal disease. 2. active known malignancy; remission of \< 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study. 3. current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or type i diabetes mellitus. 4. any other non-cardiac condition that substantially decreases survival. 5. significant valvular stenosis or hypertrophic cardiomyopathy. 6. unable to comply with gh injection. 7. pregnancy or women of child bearing age not using adequate contraceptive means. 8. unstable angina, acute myocardial infarct, cardiac surgery, or ptca within 3 months. 9. cor pulmonale. 10. acute myocarditis. 11. known need for cardiac surgery (e.g., valvular intervention, or cabg, or ptca) within the next 6 months. 12. clinical hypothyroidism or hyperthyroidism with biochemical corroboration (tsh \> 7 or \< 0.2) at screening. 13. patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible). 14. sustained ventricular tachycardia (lasting \> 30 seconds) on screening holter. 15. significant liver disease (inr\>1.4 off anticoagulant therapy; or ast, or alt, or ggt, or alkaline phosphatase \> 3x upper limit of normal; or bilirubin \> 2x the upper limit of normal) at baseline. 16. failure to give informed consent

Keywords: severe heart failure growth hormone exercise capacity quality of life cardiac function
femoral or radial approach in coronary chronic total occlusion

Conditions: Chronic Coronary Occlusion

Summary: pecutaneous coronary intervention (pci) of chronic total occlusions (ctos) is most commonly performed using bilateral transfemoral access and 8 french guiding catheters. however, transfemoral approach (tfa) is associated with higher risk of vascular access complications.5 it has been reported that using transradial approach (tra) reduces vascular complications and may be associated with a better clinical outcome. transradial access is also used in complex pci interventions.there is a growing body of evidence regarding the use of this approach also in cto procedures. in available literature, all studies comparing tra vs. tfa in cto consisted of single center and single operator experience. besides, none of them is randomized. to fill in the gap, we sought to examine the technique and outcomes of transradial vs. transfemoral cto pci in a contemporary multicenter randomized study.

all consecutive patients referred for cto pci between august 2017 and july 2021 at acibadem university kocaeli acibadem hospital, kocaeli; erciyes university medical faculty, kayseri; istanbul university cerrahpasa medical faculty, haseki cardiology institute; istanbul; memorial bahcelievler hospital, istanbul were screened for enrollment in the study. the exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe heart failure issues; (c)severe renal failure (d) failure to provide written informed consent.the radial access group consisted of patients with single or bi-radial approach. any femoral artery puncture was considered a femoral case. for example, a crossover from any radial to femoral access was considered a femoral case. procedures were performed by 4 interventional cardiologists, who are dedicated radial operators, at 4 different centers. the protocol was approved by the institutional review board and all patients provided written informed consent.

Eligibility criteria:
inclusion criteria: * any patient with coronary total occlusion \>3 months and indication for intervention exclusion criteria: * acute coronary syndrome within 3 months

Keywords: femoral approach radial approach chronic total occlusion
effect of partially hydrolyzed formula with synbiotics on skin barrier function

Conditions: Atopic Dermatitis (AD)

Summary: the main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. other efficacy and safety parameters will be assessed as well.


Eligibility criteria:
inclusion criteria: 1. written informed consent has been obtained from at least one parent or legally acceptable representative (lar), if applicable 2. infant gestational age ≥ 37 completed weeks 3. infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg 4. infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment 5. infant from singleton birth or infant from multiple births may if all birth siblings are enrolled. 6. at least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire 7. a. for the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age. or b. for the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. the decision to introduce formula feeding was independently made by the parents before enrollment. 8. parents/lar must be able to provide evidence of parental authority and identity. 9. infant's parent(s)/lar must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol. exclusion criteria: 1. infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes. 2. infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding. 3. infant has already been diagnosed with allergy by a physician, including ad and/or cow's milk allergy. 4. infant is currently participating or has previously participated in another clinical trial prior to enrollment. 5. infant's parents or lars have not reached legal age of majority (18 years).
glucosamine sulphate and increased level of blood cholesterol

Conditions: Osteoarthritis

Summary: glucosamine sulphate causes no changes in blood levels of cholesterol

the effects on glucosamine sulphate on blood levels of choleterol is measuered in patients with mild to moderate osteoarthritis

Eligibility criteria:
inclusion criteria: osteoarthritic pain, normal blood cholesterol levels - exclusion criteria: systemic diseases, pregnancy, need of medication besides painkillers -

Keywords: glucosamine sulphate, osteoarthritis, cholesterol,