Kornimate/medical-research-clean huggingface dataset:
nash-fitter: nonalcoholic steatohepatitis fitness intervention treatment targeting endothelial dysfunction reversal

Conditions: Non-Alcoholic Fatty Liver Disease; Non Alcoholic Steatohepatitis; NASH - Nonalcoholic Steatohepatitis

Summary: this research is being done to find out if aerobic exercise is beneficial in reversing scarring. physical activity has been shown to increase fitness in healthy individuals as well as in those with nash. this research will allow for better understanding the effects of physical activity on fitness and endothelial function in patients with nash with the goal of reversing scarring. approximately 12 people will take part in this research study at penn state (psu) milton s. hershey medical center (hmc), penn state physical medicine \& research (pm\&r) laboratories housed at the hershey center for applied research (hcar) and the penn state university fitness center (ufc).

preliminary studies show universally low cardiorespiratory fitness (crf) in nonalcoholic steatohepatitis (nash) patients was dependent on body composition. the proposed work is based on the hypothesis that gains in cardiorespiratory fitness and improved endothelial function achieved through exercise can arrest or reverse progression of hepatic fibrosis, lessen cardiovascular disease risk (cvd), and improve all-cause mortality in patients with nash. the aims of this research proposal are designed to characterize and better understand the effects of physical activity (pa) on crf and endothelial function in patients with nash. the goal is to arrest progression of fibrosis and reduce cvd risk. this proposal includes a cross-sectional study and a small pilot clinical trial in a high-risk subgroup of nash most likely to benefit from pa.

Eligibility criteria:
inclusion criteria •enrollment and completion of irb study # 00011797 exclusion criteria * inability to provide informed consent * institutionalized/prisoner * non-english-speaking patients due to unavailability of translators for all visits/sessions

Keywords: fatty liver nash nafld
sensorimotor integration exercises on post-stroke balance and fall efficacy

Conditions: Stroke

Summary: to study the effect of sensorimotor integration exercises on balance and fall efficacy in sub-acute stroke by performing 18 balance training exercises with three progressive steps.

balance impairment after stroke is significantly correlated with fall risk. to improve balance and reduce fall efficacy, the participants in the study group will be trained by six weeks three progressive steps of sensorimotor integration exercises. each exercise step will take 30 minutes of a practice session, three sessions per week. conventional physiotherapy (passive and active exercises and lower extremities strengthening exercises) will be given to the control group. the changes in balance performance and fall efficacy will be measured and compared within and between groups.

Eligibility criteria:
inclusion criteria: * first episode of sub-acute stroke (from 1 to 26 weeks) referred from physicians * both sexes * age above 20 * good cognition (mini mental state examination scale ≥24) * moderate and moderately severe disability (modified rankin scale- 3 and 4) * impaired balance (bbs \<41) exclusion criteria: * recurrent stroke * associated with other neurological conditions (such as parkinson's disease, epilepsy, meningitis) * deficits of somatic sensation involving the paretic limb (fugl-meyer assessment - sesation\< 1) * lower extremity weight bearing pain (fugl-meyer assessment- pain \<1) * low back pain (vas ≥ 3) * severe visual deficits which cannot be corrected by lens or glasses * symptomatic vestibular disorders (paroxysmal postural vertigo) * associated serious cardiac disorder

Keywords: sensory motor integration exercise
equine facilitated cbt group therapy for youth anxiety

Conditions: Anxiety

Summary: the purpose of this study is to evaluate a 10-week equine facilitated cognitive behavioral therapy (cbt) group program for youth between ages of 6 to 17 with symptoms of anxiety. the program will be delivered at gallopnyc, a stable that provides equine-facilitated group therapy to youth with a range of mental health problems.

the equine-facilitated group therapy normally provided at gallopnyc (treatment as usual, tau) will be compared to an augmented group program that will include cbt strategies, including psychoeducation to the child and caregiver about anxiety, coping strategies to use when anxious, and identifying and addressing dysfunctional thoughts that maintain anxiety. seventy-five children between 6 to 17 years of age will be randomized to tau (equine-facilitated group therapy), the augmented group therapy that contains cbt strategies, or wait list control. outcomes include anxiety symptoms, self-efficacy,receipt of services, functioning and the child's relationship with the horse.

Eligibility criteria:
inclusion criteria: * a child aged 6-17 seeking services for anxiety at gallop nyc, who (based on the screener administered by gallopnyc) evidence symptoms of anxiety (as measured by a score of 2 or more on the gad 2 item questionnaire) and a minimum functioning score of 51 (as measured by the child global assessment scale) * caregivers will also serve as study respondents. to do so, they must meet the following criteria: * primary caregiver/ legal guardian of a child who meets eligibility criteria * aged 18 years or older * english speaking providers will serve as study therapists. to do so, they must meet the following criteria: * path-certified provider employed at gallop nyc exclusion criteria: * inability to provide informed consent * child does not meet criteria for anxiety symptoms (as measured by a score of 2 or more on the gad 2 item questionnaire) and/or does not meet minimum level of functioning (does not meet a minimum functioning score of 51 as measured by the child global assessment scale)
effect of cpap on blood pressure in patients with sleep apnea and refractory hypertension

Conditions: Obstructive Sleep Apnea; Refractory Arterial Hypertension

Summary: the purpose of this study is to determine the effects of cpap treatment on blood pressure in patients with sleep apnea syndrome (sas) and refractory arterial hypertension (rah). also, some of the mechanisms mediating sas and rah (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed.


Eligibility criteria:
inclusion criteria: * refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15 exclusion criteria: * excessive sleepiness * professional drivers * secondary arterial hypertension

Keywords: obstructive sleep apnea refractory arterial hypertension continuous positive airways pressure
early adjuvant diagnosis of pulmonary nodules based on ctc.

Conditions: Pulmonary Nodules, Solitary; Pulmonary Nodules, Multiple

Summary: the goal of this observational clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. the main questions it aims to answer is: the sensitivity and specificity of peripheral blood circulating tumor cell detection in differentiating benign and malignant pulmonary nodules (≤3cm). participants will be asked provide 4ml of peripheral blood for the test.

the aim of this clinical trial is to evaluate the value of circulating tumor cell detection in the early diagnosis of malignant pulmonary nodule. patients with clinical suspected malignant pulmonary nodules will be included in this trial. peripheral blood of participants will be collected before surgery or biopsy. clinical and imaging data of enrolled patients will also be collected. pathological diagnosis is the gold standard for differentiating benign and malignant pulmonary nodules. the sensitivity and specificity of ctc detection for diagnosing malignant pulmonary nodules will be analyzed.

Eligibility criteria:
inclusion criteria: 1. patients with single or multiple pulmonary nodules on ct imaging; 2. subjects ≥18 years old, regardless of gender, occupation, and region, should have independent capacity for civil conduct and sign the informed consent for clinical study; 3. subjects are generally in good condition, with ecog score 0-1 and life expectancy of no less than 2 months; 4. organ function level requirements: 1. peripheral blood: 1.5 x 10\^9/l≤ absolute neutrophil count (anc) ≤15 x 10\^9/l, platelets ≥100 x 10\^9/l, hemoglobin ≥9.0 g/dl; prothrombin time (pt) ≥11 seconds, international normalized ratio (inr) ≥0.8; 2. bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5 times the upper limit of normal; 3. serum creatinine ≤1.5 times the upper limit of normal value. exclusion criteria: 1. the subjects had a history of malignant tumors, or serious cardiovascular and cerebrovascular diseases (had undergone heart stent surgery within 6 months or had been admitted to icu, ccu or other intensive care units due to cardiovascular and cerebrovascular diseases, or ef≤50%); b. severe vasculopathy, pulmonary tuberculosis or large-scale acute inflammation (including but not limited to acute bronchitis, vasculitis, etc.) or active chronic infection (hiv, hbv, hcv, etc.) within 3 months; 3. poor compliance, unable to cooperate with the research program; 4. participants in any drug trial within three months prior to enrollment; 5. pregnant or breastfeeding; 6. puncture/surgical contraindications.
erector spinae plane block (espb): in patients undergoing surgery through a flank or anterior subcostal incision.

Conditions: Nephrectomy; Partial Nephrectomy; Incision Site Discomfort

Summary: using a randomized double-blinded study design, the study goal is to evaluate the superiority of erector spinae plane block (espb) in the peri-operative pain management of patients undergoing surgery through a flank or anterior subcostal incision as compared to the standard of care of using iv and oral opiates.

40 subjects will be randomized in to 2 groups, with 20 in each group. * group 1. erector spinae plane block (espb) (containing ropivacaine) * group 2. sham erector spinae plane block. (sespb) (with normal saline)

Eligibility criteria:
inclusion criteria: * consenting adults age 18-85 * american society of anesthesiologists (asa) physical status classification i to iii * planned to be hospitalized for at least 24 hours post-op * cognitive capacity to use the visual analogic scale (vas) and complete the patient satisfaction survey exclusion criteria: * patient refusal * patients with allergies to local anesthetics or opiates (hydromorphone or oxycodone) * scoliosis * patients with chronic pain syndromes or who are on chronic pain medications/other neurologic medication of more than 3 months or whom have neuromodulators/stimulators * concurrent surgeries requiring additional incisions on the body

Keywords: kidney surgery analgesia surgical incision opioid sparing flank pain local anesthesia
effects of quetiapine on sleep and next day alertness in people with obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: quetiapine is medication used to treat schizophrenia and bipolar disorder. increasingly, low doses of quetiapine are prescribed "off-label" for insomnia. quetiapine increases sleep duration with fewer interruptions, and people report feeling more rested. this accounts for why it is popular to prescribe for insomnia. insomnia and obstructive sleep apnea (osa) share many symptoms and differential diagnosis can be difficult. while quetiapine may improve sleep and breathing in certain people (i.e in light sleepers) an initial study indicated that quetiapine caused breathing disturbances in healthy individuals. effects in osa are unknown. in this placebo-controlled double blind study, participants with mild-moderate osa will spend 2 nights in the sleep lab, one with quetiapine at a dose commonly prescribed for insomnia and one with placebo. the investigators will assess participants sleep by standard clinical sleep study, and morning alertness using questionnaires, reaction tests, and a driving simulator test.


Eligibility criteria:
inclusion criteria: * ages: 18+ (adult, older adult) * gender: all * moderate or more "difficulty staying asleep" score on the insomnia severity index questionnaire * obstructive sleep apnoea (osa), apnoea hypopnea index ≥ 5 events/hour * bmi between 18.5 and 40 kg/m2 exclusion criteria: * concomitant medications that interact or are contraindicated with quetiapine * concomitant medications known to influence breathing, sleep, arousal, or muscle physiology * current pregnancy or breast-feeding * current or recent other medical conditions likely to affect results or safety

Keywords: sleep apnea, obstructive quetiapine randomised double-blind placebo respiratory arousal threshold
evaluation of enalapril versus placebo in patients with diastolic heart failure

Conditions: Heart Failure With Preserved Ejection Fraction; Heart Failure, Congestive

Summary: background: exercise intolerance is the primary symptom in older patients with heart failure and preserved ejection fraction (hfpef), however little is known regarding its mechanisms and therapy. methods: 71 elderly stable, compensated hfpef patients (age 70+1 years; 80% women) with controlled blood pressure were randomized into a 12 month follow-up (fu) double-blind trial of enalapril 20 mg per day (e) vs. placebo (p). assessments included: peak exercise oxygen consumption (vo2); six-minute walk test; minnesota living with hf questionnaire (mlhf); mri; doppler-echocardiography; and vascular ultrasound.


Eligibility criteria:
inclusion criteria: * all participants will be 60 years of age or older. exclusion criteria: 1. systolic dysfunction 2. patients with evidence of significant ischemic or valvular heart disease 3. chronic pulmonary disease. participants who appear preliminarily eligible are invited to a formal screening visiting with an investigator cardiology physician. they also undergoing a rest and exercise electrocardiogram and echocardiogram and pulmonary function testing as well as blood hematology and chemistry tests. final eligibility will be based upon all information available at the conclusion of the screening visits test, including hospital and outpatient records, history, physical examination, echocardiogram and exercise test.
endogenous renin-angiotensin-aldosterone system and glucose metabolism

Conditions: Metabolic Syndrome

Summary: aim 1.test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion. aim 2. test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor dependent mechanism.

in aim 1 subjects are randomized to cross over between an 8 day high salt and 8 day low salt diet and assessments are made. in aim 2, subjects are randomized to a 2x2 cross over study with an 8 day low salt diet and either eplerenone 50mg or amlodipine 5mg.

Eligibility criteria:
inclusion criteria: 1. ambulatory subjects, 18 to 70 years of age, inclusive 2. for female subjects, the following conditions must be met: 1. postmenopausal status for at least 1 year, or 2. status-post surgical sterilization, or 3. if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day. 3. metabolic syndrome as defined by the presence of \> 3 of the following: 1. systolic blood pressure \> 130 mm hg or diastolic blood pressure \> 85 mm hg. 2. glucose intolerance (fasting plasma glucose ≥ 100 mg/dl) 3. increased triglyceride level \> 150mg/dl (1.7mmol/l) 4. decreased levels of hdl cholesterol (for males, less than 40 mg/dl; for females, less than 50 mg/dl) 5. waist circumference (for males, greater than 40 inches; for females, greater than 35 inches) exclusion criteria: 1. type 1 diabetes 2. type ii diabetes 3. impaired renal function 4. prior allergies to medications used in the study protocol 5. screening plasma potassium \>5.5 mmol/l or sodium \<135 mmol/l 6. cardiovascular disease 7. use of hormone replacement therapy 8. breast-feeding 9. treatment with anticoagulants 10. history of serious neurologic disease 11. history or presence of immunological or hematological disorders 12. diagnosis of asthma requiring use of inhaled beta agonist 13. clinically significant gastrointestinal impairment 14. impaired hepatic function 15. hematocrit \<35% 16. any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs 17. treatment with chronic systemic glucocorticoid therapy 18. treatment with lithium salts 19. history of alcohol or drug abuse 20. treatment with any investigational drug in the 1 month preceding 21. mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study 22. inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
community-led navigation to address disparities in mammography among native american women

Conditions: Breast Cancer

Summary: the goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the navajo nation. the intervention is tablet-based education to improve the acceptance of mammography (team). team encompasses culturally-tailored mammography education modules that were developed using a community-based participatory research process. women will be randomized to receive team or team + navigation. navigation involves monthly 1:1 support from a diné peer-navigator.


Eligibility criteria:
inclusion criteria: * self-identify as american indian or alaska native (aian) * identify as female * are 40-74 years of age * are a registered patient at chinle comprehensive healthcare facility (cchfc) * live within 80 miles of cchfc * have not received a mammogram within the prior 12 months * do not have a personal history of breast cancer * are not planning to move in the next 6 months * willing to be randomized exclusion criteria: * do not self-identify as american indian or alaska native (aian) * do not identify as female * are not 40-74 years of age * are not a registered patient at cchcf * do not live within 80 miles of cchcf * have received a mammogram within the prior 12 months * have a personal history of breast cancer * are planning to move in the next 6 months * unwilling to be randomized
a trial comparing the efficacy of subcutaneous injections of brodalumab to oral administrations of fumaric acid esters in adults with moderate to severe plaque psoriasis

Conditions: Psoriasis Vulgaris

Summary: the primary objective is to demonstrate added benefit of brodalumab versus a selected systemic comparator in treatment of moderate to severe plaque psoriasis in germany in subjects who have not previously received systemic treatment for psoriasis. fumaric acid esters have been selected as the comparator because it is an established systemic treatment of psoriasis in germany.

a 24-week, randomised, open-label, active-controlled, parallel group, multi-centre trial with investigator-blinded efficacy assessments

Eligibility criteria:
main criteria for inclusion: * men or women ≥18 years of age at the time of screening. * subjects with chronic plaque type psoriasis diagnosed at least 6 months before randomisation. * subjects with moderate to severe plaque psoriasis in whom topical therapy is not adequate and who are candidates for systemic therapy, defined at randomisation by pasi 10, affected bsa \>10%, and dlqi \>10. * subject has no known history of active tuberculosis. * subject has a negative test for tuberculosis taken at screening (negative quantiferon test). * subject and/or subject's designee is/are capable of administering subcutaneous injections. main criteria for exclusion: * previous or current systemic treatment of plaque psoriasis or known contraindication for systemic therapy. * previous or current puva (psoralens and ultraviolet a) therapy. * washouts and non-permitted drugs: 1. have received phototherapy (uva light therapy without psoralens, uvb light therapy, excimer laser, tanning beds etc. within 4 weeks of baseline, or 2. have had topical psoriasis treatment within 2 weeks of baseline (exceptions: bland emollients without urea or beta or alpha hydroxy acids) 3. have received any biologic immune modulating treatments used for indication other than psoriasis within 4 weeks of baseline or within a period of 5 half-lives of the imp, whichever is longer 4. have received any other systemic immune modulating treatment (including but not limited to oral retinoids, methotrexate, calcineurin inhibitors, oral or parenteral corticosteroids etc. used for indications other than psoriasis) within 4 weeks of baseline or within a period of 5 half-lives of the imp, whichever is longer. * subjects with any of the following laboratory abnormalities at screening: 1. leukocyte cell count below 3×10\^9/l or lymphocyte count below 0.7×10\^9/l 2. aspartate aminotransferase (ast) or alanine transferase (alt) \> 2× uln (upper level of normal limit) 3. absolute neutrophil count \< 2×10\^9/l 4. serum creatinine \> uln. * history of depressive disorder within the last 2 years including current antidepressive treatment. * subjects with a history of suicidal behaviour (suicide attempt). * any suicidal ideation of severity 4 or 5 based on the ec-ssrs questionnaire at screening. * a phq-8 score of ≥10 corresponding to moderate to severe depression at screening.