Kornimate/medical-research-clean huggingface dataset:
uv1 vaccine with pembrolizumab for patients with unresectable or metastatic melanoma

Conditions: Malignant Melanoma

Summary: uv1 is a therapeutic cancer vaccine that has been explored in prostate and lung cancers, and in combination with ipilimumab in malignant melanoma. this study will explore the safety, tolerability and efficacy of uv1 administered with gm-csf in melanoma patients who are also receiving pembrolizumab.


Eligibility criteria:
key inclusion criteria: 1. stage iiib, iiic or iv melanoma 2. previously untreated and eligible for pembrolizumab treatment (prior treatment with braf and mek inhibitors permitted) 3) adequate blood, liver and kidney function 4) consent to undergo tumor biopsies during the study exclusion criteria: 1. uveal or ocular malignant melanoma 2. history of hematologic or primary solid tumor malignancy with the exception of patients in remission for at least 5 years, as judged by the investigator are allowed 3. prior systemic treatment for unresectable or metastatic melanoma. exception: prior treatment with braf and mek inhibitors permitted. a washout period of at least 3-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed. 4. prior therapy with an anti-ctla4, anti-pd-1, anti-pd-l1, anti-pd-l2 agent or oncolytic virus. 5. known hypersensitivity to gm-csf 6. women who are breastfeeding, pregnant or expect to be pregnant during the study through 6 months after the last dose 7. men who plan to become a father during the study through 4 months after the last dose of study medication 8. known history of, or any evidence of active, non-infectious pneumonitis 9. history of cardiac disease
post market clinical follow-up of the zimmer stafit acetabular system

Conditions: Osteoarthritis, Hip; Fracture of Hip; Avascular Necrosis of Hip; Dislocated Hip; Osteonecrosis; Post-traumatic; Arthrosis; Rheumatoid Arthritis; Subluxation Hip

Summary: this study is a post market clinical follow up study to fulfil the post market surveillance obligations according to medical device directive and european medical device vigilance system (meddev) 2.12-2. the data collected from this study will serve the purpose of confirming safety and performance of the zimmer stafit acetabular system.

the objective of this study is to obtain implant survival and outcome data on the stafit acetabular system by analysis of standard scoring systems, radiographs, and adverse event records. data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the stafit acetabular system in primary total hip arthroplasty. the study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the stafit acetabular system.

Eligibility criteria:
inclusion criteria: * males and females * patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty. * 18 years minimum * patients able to participate in a follow-up program based upon physical examination and medical history * patients who have provided written informed consent by signing the patient informed consent form. exclusion criteria: * patients who are unwilling or unable to give informed consent, or to comply with the follow-up program * known pregnancy * revision hip arthroplasty
effect of dalfampridine in patients with hereditary spastic paraplegia

Conditions: Hereditary Spastic Paraplegia

Summary: there are limited but encouraging results supporting the use of dalfampridine in patients with hereditary spastic paraplegia. the investigators aimed to investigate the effects of dalfampridine on walking speed, muscle length, spasticity, functional strength, and functional mobility in patients with hereditary spastic paraplegia. in this triple-blinded, randomized, placebo-controlled trial, 4 patients with hereditary spastic paraplegia received dalfampridine (10 mg twice daily) plus physiotherapy (2 times per week), and 4 patients received placebo plus physiotherapy for a total duration of 8 weeks. the assessor and treating physiotherapists, and patients were masked to the group allocation. the primary outcome was timed 25-foot walk test at the end of the 8-week treatment. the secondary outcome measures were functional mobility, functional muscle strength, muscle length, and spasticity.


Eligibility criteria:
inclusion criteria: * diagnosis of hereditary spastic paraplegia at least 1 year ago exclusion criteria: * having another neurological disorder * an orthopedic deformity in the lower extremity * having a serious cognitive impairment
sleep apnea and refractory hypertension: prevalence and effect of cpap treatment

Conditions: Hypertension; Sleep Apnea

Summary: a small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that cpap treatment achieves a significant reduction of blood pressure in the short term. the purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.

we assess the prevalence of an apnea hypopnea index (ahi) \> 5 in patients with refractory hypertension referred from a hypertension clinic. patients with an ahi \>15 are randomized to either continuing their usual pharmacological treatment alone or adding cpap to their usual treatment, during a 3 month period. the main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as assessed by ambulatory blood pressure monitoring, between both treatment arms. the secondary endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis

Eligibility criteria:
inclusion criteria: * patients referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmhg despite the recommended doses of at least 3 drugs, including a diuretic. exclusion criteria: * causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.

Keywords: sleep apnea refractory hypertension continuous positive airway pressure
the therapeutic effect of exercise training on patients with dementia and mild cognitive impairment

Conditions: Dementia

Summary: this study aimed to clarify whether strength training or aerobic training could bring more benefits for patients with dementia, another study is to clarify whether isokinetic or isotonic training could bring more benefits for patients with mild cognitive impairment

exercise training has been evidenced to bring various of benefits for patients with dementia in past studies. however, whether strength training or aerobic training could bring better benefits has not been confirmed in the past. this study designed to recruit 30 patients with mild dementia in the first year. every patient will receive strength training using dumbbells, butterfly machine and vertical leg press machine for four weeks. outcome measures including self care ability, cognitive function, mcp-1, bdnf and igf-1 levels, and the degree of depression will be recorded before and after the training. in the second year, the investigators also designed to recruit 31 patients with mild dementia. these participants will instead receive aerobic training using stationary bicycle for four weeks. the same outcome measures will be tested as in the first year. the other part of the study recruited 46 patients with mild cognitive impairment, who were randomized into either a four-week isokinetic or isotonic training program. all cases were evaluated by isokinetic peak torque, 36-item short form survey (sf-36), mini-mental state examination (mmse), barthel index, geriatric depression scale (gds-15), and timed up and go test (tug test) before and after each kind of training.

Eligibility criteria:
inclusion criteria: 1. patients aged above 65 years old 2. patients with mild dementia with mini-mental state examination scoring 15 to 26 3. another arm is patients with mild cognitive impairment and mini-mental state examination scoring 23 to 27 exclusion criteria: 1. cardiopulmonary diseases or orthopedical conditions that prohibit the patient from receiving exercise training of our programs 2. cognitive problems that impede the patient to understand and answer the content of our questionnaires.

Keywords: dementia
program of community oral function enhancement

Conditions: Oral Hypofunction

Summary: the purpose of this study examined the effects of oral exercise on oral function among older adults in taiwan, focusing on gender-related outcome differences. seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal. after six-week, the participants were examed the salivary secretion, swallowing ability (rsst), oral diadochokinesis, bite force, quality of life (assessed by ohip-14) and eat-10.

objective: elderly individuals with systemic diseases and disabilities face an elevated mortality risk, with oral functional decline further contributing to both oral and systemic health challenges. given the rising prevalence of reduced oral function in older adults, this study aims to evaluate the effectiveness of oral exercise training on improving oral function and preventing functional decline. additionally, the study examines potential gender differences in response to the intervention. methods: seventy-seven community-dwelling older adults aged 65 and above participated in a six-week oral exercise program, performed before each meal. the study measured changes in oral function post-intervention.

Eligibility criteria:
inclusion criteria: * over the age of 65 exclusion criteria: * incomplete data * failed to perform the assigned daily exercise * unable to adhere to the protocol and steps outline in the oral exercise video

Keywords: oral exercises, community-dwelling elderly, oral function, prevention of chewing and swallowing disorders
effect of simvastatin as pulpotomy agent in cariously exposed permanent molars

Conditions: Reversible Pulpitis

Summary: the study will compare the outcome of complete pulpotomy in mature permanent mandibular molars with deep carious lesions by using mineral trioxide aggregate and simvastatin -alpha tricalcium phosphate as medicament agent

after a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure, its associated risks and benefits. clinical diagnosis of reversible pulpitis will be established. complete pulpotomy will be done in both groups. mineral trioxide aggregate and simvastatin -alpha tricalcium phosphate will be used as pulpotomy agents. pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. all the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1 year.

Eligibility criteria:
inclusion criteria: 1. patient willing to participate in the study. 2. age group of 15 to 40 years 3. mature permanent mandibular molars with reversible pulpitis (positive response on the cold test and early response as compared to the adjacent or contralateral tooth) 4. teeth exhibiting occlusal pulp exposure from primary dental caries. 5. absence of periapical lesions assessed by radiographic examination. 6. tooth demonstrating no mobility or swelling and no tenderness to percussion or palpation exclusion criteria: 1. primary teeth. 2. teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic periodontitis, cracked tooth, internal or external resorption, calcified canals, associated with sinus tract and furcation or apical radiolucency. 3. immune-compromised, pregnant and patients with any systemic disorder. 4. patients taking statin medication. 5. failure to obtain authorization from the patient.

Keywords: permanent teeth complete pulpotomy simvastatin -alpha tricalcium phosphate mineral trioxide aggregate
manage macular cystoid edema with retinal vein obstruction using traditional chinese medicine and ranibizumab

Conditions: Macular Cystoid Edema

Summary: the objective of this study was to investigate the efficacy and safety of traditional chinese medicine (jueling mingmu decoction) combined with ranibizumab in the treatment of macular edema with retinal vein obstructive.

compared to the sole intravitreal injection of ranibizumab, the combined use of traditional chinese medicine with intravitreal ranibizumab aims to determine if it is more effective in alleviating macular cystoid edema secondary to retinal branch vein occlusion, leading to improved visual prognosis and potentially reducing the frequency of intravitreal drug injections.

Eligibility criteria:
inclusion criteria: * foveal center-involved macular edema (me) lasting less than 9 months * central macular thickness (cmt) greater than or equal to 250 μm * best-corrected visual acuity (bcva) of 24-73 letters (20/40 to 20/320) in the study eye * initial diagnosis with no prior treatments, such as laser therapy or intravitreal injections exclusion criteria: * presence of any additional macular pathology, such as age-related macular degeneration (amd) or diabetic retinopathy (dr) affecting the macula * concurrent serious conditions, such as cardiovascular diseases, liver, or kidney diseases * concerns or doubts regarding treatment * known allergies to the ingredients of the medication.

Keywords: traditional chinese medicine ranibizumab retinal vein obstruction
comparison of the clinical examination and the joint ultrasonography in lupus patients

Conditions: Lupus Erythematosus, Systemic

Summary: arthritis is a current manifestation of systemic lupus erythematosus (sle) and participates to the sledai composite score calculation (0 to 105). ultrasonography (us) is a validated and sensitive tool for joint assessment. published studies showed us joint abnormalities in systemic lupus erythematosus patients with or without joint pain. nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. the objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (c-sjc) and sledai (c-sledai) score versus ultrasonography-sjc and ultrasonography-sledai.


Eligibility criteria:
inclusion criteria: * systemic lupus erythematosus patients (with or without joint involvement). * subjects will have to sign the inform consent before the beginning of the study exclusion criteria: * current pregnancy or no effective contraception

Keywords: ultrasonography clinical assesment joint abnormalities
entrust - taarget® thoracic stent graft clinical trial

Conditions: Thoracic Aortic Aneurysm

Summary: evaluate the safety and effectiveness of endovascular repair with the lemaitre taarget thoracic stent graft as an alternative to open surgical repair.

* subject is \> 18 years of age. * females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening. * subject is a candidate for endovascular thoracic aortic repair. * subject has a taa that meets one of the following criteria: * is diagnosed with a fusiform focal taa \>5cm, or * is diagnosed with a fusiform focal taa that has a diameter \< 5 cm and has exhibited rapid expansion, or * is diagnosed with a fusiform focal taa that has a diameter ≥ 4.5 cm and is at least twice the size of the normal dta, or * is diagnosed with a saccular taa of any size.

Eligibility criteria:
inclusion criteria: * subject is \> 18 years of age. female subjects are either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and have a negative serum pregnancy test at screening. subject is a candidate for endovascular thoracic aortic repair. subject has a taa that meets one of the following criteria: 1. is diagnosed with a fusiform focal taa ≥5cm, or 2. is diagnosed with a fusiform focal taa that has a diameter ≤ 5 cm and has exhibited rapid expansion, or 3. is diagnosed with a fusiform focal taa that has a diameter ≥ 4.5 cm and is at least twice the size of the normal dta, or 4. is diagnosed with a saccular taa of any size (where potential for rupture is increased\*). * tortuosity and angulation do not exceed 90 degrees. * subject has an arterial access site that allows for the introduction of the stent-graft delivery system. exclusion criteria: * subject has a life expectancy \< 2 years. * subject has a lesion that prevents safe delivery or expansion of the device. * subject has concomitant ascending aortic aneurysm. * subject has known allergies to any of the device materials. * subject has coagulopathy or bleeding disorders that cannot be pre-treated. * subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.

Keywords: taa thoracic descending thoracic aorta taarget
evaluation of zinc intake on essential fatty acid metabolism

Conditions: Inflammation; Oxidative Stress; Dyslipidemias

Summary: the purpose of this study is to determine the effect of different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers

this research is a dietary intervention study designed to evaluate the effect of progressive changes in zn intake on fatty acid metabolism and to correlate those changes with biomarkers of dyslipidemia and insulin resistance. the main objective is to validate plasma fatty acid metabolism as a biomarker of inadequate zn intake in subjects consuming identical diets with specific zn content. the relative sensitivity of some fatty acid enzyme activities will also be compared to the dna strand breaks. in addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. this will enable the determination of the effect of a low zn intake on various aspects of dyslipidemia. similar correlational analyses will be performed with clinical measures of inflammation and insulin resistance.

Eligibility criteria:
inclusion criteria: * willing to limit food and beverage intake to that provided by the study * willing to discontinue consumption of alcoholic beverages during the study * willing to stop zinc supplementation 4 weeks prior to start of the study * has an operative understanding of english * no plans to move from the area during the study period exclusion criteria: * chronic or acute metabolic disease * smoker or user of nicotine products * history of alcohol abuse, or use of illicit drugs. * is underweight or overweight, body mass index (bmi) \ 30 kg/m2.
remimazolam and propofol on the left ventricular strain during anesthesia induction for non-cardiac surgery

Conditions: Surgical Procedure, Unspecified

Summary: this study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (lv-gls) during anesthesia induction for non-cardiac surgery. lv-gls is analyzed by using speckle tracking technique of transthoracic echocardiography.

this study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (lv-gls) during anesthesia induction for non-cardiac surgery (n=40). remimazolam or propofol is randomly administered for anesthesia induction (group-r and group-p, respectively) the changes of lv-gls are analyzed by using using speckle tracking technique. for this study, 2-dimensional of transthoracic echocardiography lv images (apical 2-chamber, 3-chamber, and 4-chamber views) are recorded and stored before administration of remimazolam/propofol (t0), 2 minutes after the administration (t2), 4 minutes after the administration (t4), and 6 minutes after the administration (t6). after the completion of the study, lv-gls values at t0, t2, t4 and t6 are determined by the off-line analyses of the recorded and stored 2d-images. for the off-line determination of lv-gls, an automated software of speckle-tracking technique (qapp autostrain-lv™, philips) is employed. the primary measure: inter-group comparison of the lowest lv-gls value out of lv-gls values at t2, t4, and t6. the secondary measures: inter-group comparisons of the lv-gls values at t0, t2, t4 and t8. intra-group comparisons of the lv-gls value at t0 vs. those at t2, t4 and t8

Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction\> 50% * no left ventricular regional wall motion abnormality exclusion criteria: * atrial fibrillation * unfavorable airway * hypotension requiring inotropic support
positive psychology intervention for spanish-speaking hispanic/latino adults at risk for cardiovascular disease

Conditions: Uncontrolled Hypertension; Cardiovascular Risk Factor

Summary: the largest epidemiologic study of hispanic/latino participants thus far, i.e., the hispanic community health study/study of latinos (hchs/sol) documented that 80% of men and 71% of women have at least one major cardiovascular disease (cvd) risk factor. the american heart association emphasizes that current cvd prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. this observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week positive psychology (pp) intervention (compared to an attention control condition) in hispanic/latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.

the study features piloting of a cluster-randomized trial to determine whether a positive psychology (pp) intervention is associated with greater improvements in blood pressure compared to an attention control condition. the pilot trial additionally evaluates the efficacy of the pp intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity c-reactive protein. serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.

Eligibility criteria:
inclusion criteria: * hispanics/latinos recruited from catholic church sites in chicago-land area * aged ≥18 * fluent in english or spanish with ≥8th grade education * elevated 24-hour ambulatory blood pressure levels (systolic bp\> 140 mmhg and \>90 mmhg for diastolic bp). exclusion criteria: * unavailable for study period; have cognitive impairment denoting dementia * have severely reduced life expectancy * are currently enrolled in psychotherapy or take prescribed antidepressants * history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse * have severe depression.

Keywords: hispanics/latinos underserved population