Kornimate/medical-research-clean huggingface dataset:
"gameday ready": evaluating a behavioral weight management program for black men living in the rural south

Conditions: Obesity; Physical Inactivity; Diet, Healthy

Summary: the primary objective of this study is to test the feasibility and acceptability of a 12-week behavioral weight management intervention adapted for black men living in the rural south. the intervention is guided by self-determination theory of motivation, social cognitive theory, and ecological systems theory. key aspects of the intervention include a football-themed curriculum, facilitator and peer concordance to the extent possible (ie., similarly aged black men), an emphasis on male-specific health concerns, group-based competition at multiple levels of the intervention (e.g., during in-person physical activity sessions and for achieving behavioral goals), a limited educational component, and physical activity being a substantial component of meeting sessions.


Eligibility criteria:
inclusion criteria: * self-identified african american or black american male * bmi 27kg/m\^2 to 50kg/m\^2 (healthcare provider approval required for those with a bmi \>45) * able to speak and understand english exclusion criteria: * positive response to any question on the physical activity readiness questionnaire (par-q) (participant may be included if approval is provided and documented by a healthcare provider) * currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention * uncontrolled hypertension (systolic blood pressure ≥160 mm hg or diastolic blood pressure ≥100 mm hg), diabetes, or asthma (participant may be included if approval is provided and documented by a healthcare provider) * pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators * any musculoskeletal condition that would preclude meeting recommended levels of moderate-to-vigorous physical activity * within 30 days prior to participating in the intervention, have taken prescription or nonprescription medications, herbals, or supplements for weight loss * on special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia) * major surgery in the past 6 months * have undergone weight loss surgery or considering surgery * have been treated for cancer in the past 12 months (other than non-melanoma skin cancer) * weight loss ≥5% during the past 6 months * any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss * intending to move within 6 months
an observational study of mircera in patients with chronic renal anemia on dialysis (ckd stage v) or not on dialysis (ckd stage iii-iv)

Conditions: Anemia

Summary: this observational study will evaluate the use and efficacy of mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (ckd) stage iii-iv not on dialysis or ckd stage v on dialysis. patients will be followed during 12 months of treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * patients with chronic renal anemia with stage iii-iv ckd not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months * patients with chronic renal anemia with stage v ckd on dialysis * no contraindication to esa treatment exclusion criteria: * uncontrolled hypertension * hypersensitivity to the active substance or any other of the excipients of mircera and other esas
zinc/psa ratio as a novel biomarker for prostate cancer detection

Conditions: Prostate Cancer Detection

Summary: although prostate specific antigen (psa) is a useful marker for early detection of the prostate cancer, its specivity is not sufficient. several psa variations were defined in order to increase the specivity of the test, but they aren't much more effective than the psa alone for detection of disease. in older studies reported that, serum and prostatic tissue zinc levels decreased in prostat cancer disease. in our study we aimed to establish the utility of serum zinc, psa, free psa/psa (fpsa/tpsa), zinc/psa, levels for early detection of the prostate cancer.


Eligibility criteria:
inclusion criteria: patients with luts and elevated serum psa levels and/or suspicious rectal examination exclusion criteria: usage of zinc included drugs, older prostatic operations, older prostatic radiotherapy, older prostatic biopsies, chronic rectal diseases (anal fissure, hemorrhoid, etc..), pin(prostatic intraepithelial neoplasia) and asap(atypical small acinar proliferation) in pathologic evaluation.

Keywords: prostate cancer, psa, zinc, zinc/psa
assessment of vertigo and dizziness in individuals following covid-19

Conditions: COVID-19

Summary: this cross-sectional study aimed to assess the prevalence of dizziness/vertigo in individuals following covid-19 and to investigate potential risk factors associated with these symptoms. a total of 296 patients aged 20-66 years who had recovered from covid-19 were evaluated at istanbul physical medicine and rehabilitation training and research hospital between june 1, 2021, and december 31, 2021. clinical and demographic data, including covid-19 history, comorbidities, and symptom characteristics, were collected. dizziness-related disability was assessed using the dizziness handicap inventory (dhi), while balance performance was evaluated with the berg balance scale (bbs).


Eligibility criteria:
inclusion criteria: * individuals aged 20-66 years. * history of confirmed covid-19 infection. * ability to speak and understand turkish. * willingness to provide verbal and written informed consent. exclusion criteria: * pre-existing vertigo or balance disorders (e.g., benign paroxysmal positional vertigo, ménière's disease, vestibular migraine, vestibular neuritis). * inner ear diseases or vestibular dysfunction. * neurological disorders affecting balance (e.g., multiple sclerosis, parkinson's disease, history of stroke, epilepsy). * psychiatric conditions that could cause dizziness (e.g., anxiety, panic attacks, depression). * history of head or neck trauma in the past six months. * moderate to severe visual impairment. * chronic alcohol or substance use. * use of ototoxic medications. * severe cardiovascular diseases (e.g., orthostatic hypotension, advanced heart failure, severe arrhythmias). * pregnant or breastfeeding women. * acute infection other than covid-19 in the past three months. * severe covid-19 requiring hospitalization
conduction system pacing vs biventricular pacing in systolic dysfunction and wide qrs: mortality, heart failure hospitalization or cardiac transplant

Conditions: Cardiac Resynchronization Therapy; Heart Failure

Summary: conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide qrs: mortality, heart failure hospitalization or cardiac transplant (consyst-crt ii trial). superiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant or heart failure hospitalization at 12-month follow-up.

to date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy. this study will randomize 320 patients to a strategy of biventricular pacing versus conduction system pacing. consyst-crt ii study will analyze a clinical endpoint as primary endpoint and the following parameters in both groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (\>=15% decrease in left ventricular end-systolic volume), nyha functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, qrs shortening, echocardiographic dyssynchrony (atrioventricular, interventricular, intraventricular) and global longitudinal strain. as a secondary endpoint, baseline predictors of response to conduction system pacing and biventricular pacing according to cardiac magnetic ressonance and electrocardiographic imaging will be studied. clinical, electrocardiographic, echocardiographic follow-up will be performed during 12 months.

Eligibility criteria:
inclusion criteria: * patient must indicate acceptance to participate in the study by signing an informed consent document. * patient must be ≥ 18 years of age. * left bundle branch block, qrs ≥130 and lvef \<=35%. no indication of stimulation for av block. * non-left bundle branch block, qrs ≥150 and lvef \<=35%. * resynchronization therapy indication for ventricular dysfunction (lvef \<40%) and indication of cardiac pacing for av block. * lvef \ =130 ms, provided a strategy to ensure biventricular capture is in place. exclusion criteria: * myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months. * pregnancy. * participating currently in a clinical investigation that includes an active treatment.

Keywords: left bundle branch pacing biventricular pacing cardiac resynchronization therapy
chronic obstructive pulmonary disease

Conditions: COPD

Summary: chronic obstructive pulmonary disease (copd) is a preventable respiratory characterized by airflow obstruction that is not fully reversible. this disease a major cause of mortality worldwide. it is projected to rank the third-leading cause of death in 2020. the objective of this study is to examine the effects of a physical therapy intervention in stable patients with copd.

chronic obstructive pulmonary disease (copd) patients have demonstrated important balance impairment (1).the deficit in balance control is identified as one of the risk factors of fall in subjects with copd and alters their activities daily life (2,3). porto and al. (2015) reported in a recent review that individuals with copd have a decline in balance control when compared with healthy age matched controls(4).

Eligibility criteria:
inclusion criteria: * copd diagnosed by pulmonary function testing * clinically stable * abscence of other obstructive diseases * signed written consent * fall in the past five years or recent near fall exclusion criteria: * neuromuscular diseases * severe psychiatric, neurologic or musculoskeletal conditions and /or instable cardiovascular diseases. * contre-indications to physical therapy * acute exacerbations a month before the intervention

Keywords: copd, exercise training
an epidemiological study to evaluate standard daily practice in managing patients with arterial hypertension

Conditions: Hypertension

Summary: this study is aimed to evaluate response rate of the antihypertensive treatment with a calcium antagonist in real life practice, to evaluate patients' quality of life and to collect the following serbia-specific epidemiology data on hypertension: demographic data, patents characteristics, and patients' management/treatment.


Eligibility criteria:
inclusion criteria: * subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist

Keywords: essential arterial hypertension calcium antagonist
validation of the peripheral arterial tone to detect sleep-disordered breathing in patients with chronic heart failure

Conditions: Sleep-Disordered Breathing

Summary: a prospective validation study: level i-full night-polysomnography (psg) versus a diagnostic device with measurement of the peripheral arterial tone (pat) of patients with chronic heart failure (chf) and sleep-disordered breathing (sdb).

patients with chronic heart failure (chf), reduced left ventricular ejection fraction (lvef\<45%) and predicted sleep-disordered breathing (sdb) receive a diagnostic device (watchpat 200 (tm)) and polysomnography (psg) simultaneously during on night in a hospital sleep lab. the watchpat 200 (tm) is a wrist worn diagnostic device for detecting sdb. its main part is the measurement of the peripheral arterial tone (pat) via a plethysmographic based finger-mounted probe. it can measure the level of sympathetic activation of the autonomic nervous system. pulse rate, oxygen saturation and snoring/body position levels are calculated, too. a software program (zzzpat (tm)) with a special algorithm analyzes the raw data and creates a sleep report. therefore the property of the watchpat 200 (tm) proclaims that the watchpat 200 (tm) can detect sleep events and sdb. the psg is scored by sleep lab physicians/technicians blinded to the zzzpat (tm)-software results using current american academy of sleep medicine (aasm) guidelines. both results will be compared and the results of the device will be validated and evaluated against the results of the "gold standard" polysomnography.

Eligibility criteria:
inclusion criteria: * reduced left ventricular ejection fraction (lvef) \< 45 % * indication for a polysomnography exclusion criteria: * allergies against the device or parts of the device * psychogenic or neurological disorders which do not allow a sufficient patient compliance * osteogenetic disorders which do not allow a painless investigation * pregnancy

Keywords: chronic heart failure sleep-disordered breathing peripheral arterial tone
pharmacodynamics and efficacy of mk-7288 in adults with sleep apnea (mk-7288-010)

Conditions: Apnea, Sleep

Summary: this is a study of the safety and efficacy of mk-7288 for the treatment of excessive daytime sleepiness (eds) in participants with obstructive sleep apnea (osa)/hypopnea syndrome (hs) who are compliant with effective nasal continuous positive airway pressure (ncpap) therapy. the goal of this study is to determine the effect of mk-7288 after single dose administration on promoting wakefulness as measured by sleep latency on maintenance of wakefulness tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).


Eligibility criteria:
inclusion criteria: * female participants are of non-child-bearing potential. * male participants who have female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study. * participant has an international classification of sleep disorders diagnosis of obstructive sleep apnea/hypopnea syndrome. * participant has excessive daytime sleepiness. * participant has been using ncpap treatment for at least 2 months. * participant reported total sleep time of \>6 hours on at least 4 out of 7 nights each week * participant is willing to stay at the sleep laboratory for 5 overnight stays. * participant is willing to limit caffeine and alcohol consumption during the study. * participant has a valid driver's license in the past 5 years and has had at least 1 year of driving experience within the past 3 years. * participant's regular bedtime is between 9:00 p.m. and 12:00 a.m. exclusion criteria: * participant has a history of cancer. * participant has any history of a significant neurological disorder. * participant has moderate or severe persistent asthma. * participant has a history of any of the following sleep disorders: narcolepsy, primary insomnia, circadian rhythm sleep disorder, shift work sleep disorder, parasomnia including nightmare disorder, sleep terror disorder, rapid eye movement (rem) behavioral disorder, and sleepwalking disorder, periodic limb movement disorder, or restless leg syndrome. * participant consumes more than 10 cigarettes a day or routinely smokes during the night. * participant, in the opinion of the investigator, has a history or current evidence of any condition, therapy, lab abnormality or circumstances that might confound the results of the study, or interfere with participation for the full duration of the study.
dietary fish and omega 3 fatty acids for breast cancer prevention

Conditions: Breast Cancer

Summary: research studies show that the type of fat in the diet may affect breast cancer risk. fish oil and fish contain increased amounts of omega 3 fatty acids which appear to stop or slow down the growth and development of breast cancer cells in laboratory studies of mice and breast cancer cells. the use of omega 3 fatty acids to reduce the risk of breast cancer development in humans has not been adequately studied. eating fish or taking fish oil may increase the amount of omega 3 in the breast, which may lower one's risk of breast cancer development. persons in this study with do one of the following: (1) take two capsules daily of omega 3 fatty acid supplements, or (2) eat several servings of canned salmon / tuna per week for a total of three months. amounts of omega 3 fatty acids in the body's tissues will be measured by blood tests and a small sample of breast fat as obtained by a fine needle aspiration. this study is supported by funding from the national fisheries institute, food innovation center of the ohio state university, and the ohio state university comprehensive cancer center.

the primary objectives of this study are to: i.) determine the effects of increased fish consumption on serum and breast fat tissue fatty acids in women at high risk for developing breast cancer relative to an omega 3 fatty acid supplement; ii.) assess adherence and tolerability of increased dietary intake of fish relative to an omega 3 fatty acid supplement. secondary objectives include: iii.) evaluate possible correlations between physical factors such as body mass index (bmi) and dietary factors and target tissue effects. iv.) explore additional biomarkers as surrogate endpoints to measure effects of fish consumption.

Eligibility criteria:
inclusion criteria: * increased risk for breast cancer based on family history, personal history * normal mammogram, clinical breast examination in the past 12 months * \>1 year from pregnancy, lactation or chemotherapy exclusion criteria: * concurrent malignancy or metastatic malignancy of any kind * history of a bleeding tendency, use of anticoagulant medications * inability to undergo fine needle aspiration of breast adipose tissue * chronic use of omega-3 fatty acid supplements or regular consumption of \> 2 meals/servings of fish per week within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements * known sensitivity or allergy to fish * standing regimen of full dose aspirin (325 mg/day or more), non-steroidal anti-inflammatory drugs (nsaids) or nsaid-containing products.

Keywords: women at high risk of developing breast cancer
pectopexy surgery without mesh

Conditions: Pelvic Organ Prolapse

Summary: it is aimed to examine the effect of laparoscopic pectopexy surgery without mesh on pelvic organ prolapse measurement (pop-q) and quality of life of the patient.

every gynecological patient with prolapse is evaluated with pop-q staging. the pop-q staging to be performed before the laparoscopic pectopexy operation without mesh (performed by using non-melting sutures with natural tissue repair) performed on the patients will be compared with the pop-q staging that will be performed 6 months after the operation. in addition, the quality of life of patients before and 6 months after the operation will be compared with the incontinence quality of life scale questionnaire of pelvic organ prolapse / incontinence sexual questionnaire (pisq-12).

Eligibility criteria:
inclusion criteria: * having pelvic organ prolapse greater than stage 2 according to pop-q evaluation system * being sexually active exclusion criteria: * disease requiring chronic steroid use * asthma * having chronic obstructive pulmonary disease * having malignancy, * having metabolic and rheumatological diseases that impair tissue healing, such as scleroderma
post-market clinical follow-up study on the safety and performance of ennovate® cervical

Conditions: Spine Fracture; Degenerative Disc Disease; Spinal Instability; Spinal Tumor; Degenerative Myelopathy

Summary: multicenter post market clinical follow-up study on the safety and performance of ennovate® cervical - prospective, pure data collection of all ennovate cervical patients in total indications

this clinical study is one of the post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the ennovate® cervical system. the study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. it includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Eligibility criteria:
inclusion criteria: * patient is minimum 18 years old * informed consent in the documentation of clinical and radiological results * patient has indication according to instructions for use (ifu) * patient is not pregnant exclusion criteria: * patient's clear unability or unwillingness to participate in follow-up examinations

Keywords: cervical spine
telehealth stepped exercise program for rural veterans with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the goal of this study is to evaluate a telehealth stepped exercise program for knee osteoarthritis (step-koa) among rural veterans. methods: this is a single arm, pre-post pilot trial of the 6-month step-koa program among rural veterans with a physician diagnosis of knee oa who self-report knee pain ≥3 on a 0-10 scale and self-reported difficulty with either walking or stair climbing. we aim to enroll 20 veterans in this project but may enroll up to 30 in order to obtain sufficient information to evaluate the program, particularly among veterans who live in very rural areas. assessments will be conducted via a combination of telephone and video at baseline and 2-, 4-, and 6-month follow-up. assessments will include questionnaires related to pain, function and physical activity, as well as several physical performance tests. step-koa begins with a low cost, primarily self-directed exercise program (supported by an internet-based tool; step 1). patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (step 2) and physical therapy (step 3) if they do not make clinically relevant improvements in prior steps. for this project, patients will be assessed approximately every 2 months to determine step progression. participants will advance to the next step if they do not meet response criteria for pain and function established by the outcome measures in rheumatology group and the osteoarthritis research society international (omeract-oarsi). the step 2 intervention involves bi-weekly telephone or video calls. step 3 involves 3 telehealth pt visits, based on standard care for knee oa.


Eligibility criteria:
inclusion criteria: * rural dwelling veterans (va healthcare users) * clinician diagnosis of knee osteoarthritis * self-reported knee pain =\>3 on a scale of 0-10 and self-reported difficulty either walking or stair climbing. exclusion criteria: * advanced dementia * psychosis * active substance abuse disorder * meniscus or acl tear in the past 6 months * total joint replacement or other major lower extremity surgery in the past 6 months * severe hearing or visual impairment (e.g. unable to participate in step-koa intervention components) * serious / terminal illness * unstable angina * history of ventricular tachycardia * unstable chronic obstructive pulmonary disease (two hospitalizations within the previous 12 months and/or on oxygen) * uncontrolled hypertension (diastolic blood pressure \>110 mm/hg or systolic \> 200mm/hg) * stroke with moderate to severe aphasia * recent history of falls * resident of a long-term care facility * hospitalization for a cardiovascular condition in the past 3 months * other health conditions that would make home exercise unsafe or participation in the program not feasible

Keywords: exercise physical therapy