Kornimate/medical-research-clean huggingface dataset:
effects of ccm-therapy in patients with heart failure

Conditions: Heart Failure

Summary: the effects of cardiac contractility modulation (ccm) treatment are observed in patients with heart failure.

the optimizer iii system is indicated for use in patients greater than 18 years of age with symptomatic heart failure due to left ventricular systolic dysfunction despite appropriate medical therapy. the study will gather additional data on the effect of ccm treatment with the objective of determining the impact of ccm on the composite of heart failure hospitalizations and mortality in the low ejection fraction (ef \< 35%) and mildly reduced ejection fraction (35 ≤ ef ≤ 45) heart failure population. the study will also assess the impact of ccm on exercise tolerance (six minute hall walk test, 6 minute walk test) and quality of life (minnesota living with heart failure questionnaire, mlwhfq) in these same populations.

Eligibility criteria:
inclusion criteria (treatment group): * any subject who receives an optimizer system implant and provides informed consent exclusion criteria (treatment group): * none inclusion criteria (control group): * symptomatic heart failure (nyha class 2, 3 or 4) despite receiving optimal medical therapy with doses of medications that are stable (no more than 50 % variation) for at least 7 days. * ef ≤ 45% * signed informed consent exclusion criteria (control group): * heart failure due to a potentially correctible cause ( e. g. valvular disease, congenital disease) * idiopathic hypertrophic cardiomyopathy, restrictive or constrictive cardiomyopathy, or heart failure on the basis of a known inflammatory or infiltrative disease (e. g. amyloidosis, sarcoidosis) or constrictive disease * active ischemia or exercise tolerance limited by angina * hospitalizations for heart failure which required the use of inotropic support within 14 days of enrollment * chronic (permanent or persistent) atrial fibrillation or atrial flutter * scheduled for a cabg or a pci procedure, or has undergone a cabg procedure within 90 days or a pci procedure within 30 days of enrollment * myocardial infarction within 90 days of enrollment * hemodialysis or peritoneal dialysis * prior heart transplant * participating in another study
coronary ct angiography in aneurysms repaired with open or endovascular approach

Conditions: Complex Aortic Surgery

Summary: this proposal is for the pilot study that will inform the conduct of a larger prospective randomized controlled trial to guide perioperative work up and the cost/utility of ctca (high definition ct coronary angiography.)

this proposal is for a pilot study that will inform the conduct of a prospective, blinded randomized controlled trial designed to determine the cost effectiveness of an algorithm for pre operative cardiac risk stratification that uses coronary ct angiography. in addition perioperative and long-term cardiac event rate will be recorded to determine if there is any difference in these rates between the 2 groups.

Eligibility criteria:
inclusion criteria: * patients being considered for a complex aortic surgery and undergoing medically indicated contrast enhanced ct aortic angiography of the chest abdomen and pelvis exclusion criteria: * patients with contraindications to undergoing ct coronary angiography * coronary revascularization within the last six months * renal dysfunction in whom the treating physician has decided a contrast enhanced ct scan is not warranted as part of the routine clinical work up
assessing the effects of patient self-rating of voice quality on voice therapy attendance and outcomes

Conditions: Dysphonia

Summary: the purpose of this study is to assess the effects of incorporating educational online modules into voice therapy. one of the main reasons that voice therapy fails is lack of participation and engagement from the patient's side. the researchers hope to learn if increasing patient engagement via educational online modules during this waiting period between evaluation and first therapy session is useful in increasing understanding of the therapeutic framework of voice therapy.

attendance and adherence are established as consistent challenges in voice therapy. specific logistical and psychological factors linked to these challenges include the interval between evaluation and initiation of treatment and components of patient motivation. the authors propose a novel online education module involving patient self-ratings of voice quality to be completed at various time points throughout the therapeutic process, including during the waiting period between initial evaluation and first treatment session. the authors hypothesize that completion of this module will increase patient understanding of the conceptual framework of therapy, provide opportunities for inclusion of patient-driven acoustic goals and establish skills in auditory and kinesthetic awareness, which are foundational to behavioral voice therapy.

Eligibility criteria:
inclusion criteria: * age \>18 years * english-speaking * have access to technology, including internet * diagnosed with dysphonia with a recommended treatment of voice therapy. * willingness to complete all clinical/research assessments * ability to give informed consent exclusion criteria: * patients who undergo surgical intervention during the course of therapy contraindications for participation in voice therapy * diagnosis of parkinson's disease or other neurodegenerative, progressive disorder (e.g., als) * previous training in acoustic-perceptual voice quality rating, for example a speech language pathology student * visual impairments that would prevent the completion of an online module. * those with self-reported moderate-profound hearing loss or deafness that would preclude them from participating in the study * inability to give informed consent
statstrip lactate, hemoglobin, and hematocrit meter in whole blood

Conditions: Sepsis; Anemia; Bleeding; Erythrocytosis

Summary: the purpose of this study is to evaluate the clinical utility of the statstrip lactate, hemoglobin and hematocrit hospital meter system in the testing of whole blood specimens from patients in hospital settings by clia waived operators, over a period of at least twenty days. the specimens shall include capillary (obtained by fingerstick), and venous whole blood. the study will also evaluate the use of a fingerstick blood contamination barrier for capillary sampling from the fingertip. this submission to the fda is intended for a point of care (poc), clia waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.

the study will be conducted at three (3) different healthcare settings (hereafter referred to as "testing sites") in poc sites/departments, by at least nine (9) cliaw operators (at least 3 in each healthcare setting), over a period of at least twenty days at each healthcare setting. examples of hospital departments include (but are not limited to) emergency department (ed), intensive care unit (icu), pediatric intensive care unit (picu), surgical intensive care unit (sicu), medical intensive care unit (micu), cardiac intensive care unit (cicu), operating room (or), where point-of-care lactate, hemoglobin and hematocrit testing can be utilized. each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. an attempt will be made to enroll 50% males and 50% females. each study subject will provide: 1. two (2) capillary whole blood fingerstick specimens 1. one lactate capillary test using the fingerstick blood contamination barrier 2. one hb/hct capillary test following traditional fingerstick protocol 2. one (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe: 1. one lactate venous test 2. one hb/hct venous test

Eligibility criteria:
inclusion criteria: * adult subjects (over or equal to 18 years old) with ordered hemoglobin and hematocrit exclusion criteria: * pediatric

Keywords: lactate hemoglobin hematocrict
sitagliptin in prevention of type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the hypothesis is, in subjects with persistent impaired glucose tolerance(igt) , sitagliptin will decrease the conversion rate to diabetes as compared to a placebo in three years.

the dpp-4 inhibitor sitagliptin may be a suitable preventive agent in subjects with igt or ifg on account of observed functional improvements in islet cell function and potential protective effect on beta cell mass. objectives of the study 1. primary objectives : - to test whether the dpp4 inhibitor sitagliptin is effective in preventing conversion of igt to diabetes when compared with a placebo. 2. secondary objectives: * to assess rates of reversal from igt to normal glucose tolerance (ngt) in igt patients administered sitagliptin * to assess the effect of sitagliptin on measure of beta cell function and insulin resistance in patients with igt. study design double blind placebo controlled, parallel group study - three years follow up . subjects with igt in the age group of 30-55 years (n=900) will be identified by screening with a standard ogtt. selected subjects will be randomized to the control arm using placebo and the two study arms using sitagliptin. at baseline all group will receive a standard advice on lifestyle modification. the dose of sitagliptin will be 100 mg/d. the subjects will be reviewed at 6 monthly intervals and repeat ogtt will be done annually. proforma containing details of anthropometry, occupation, physical activity, diet habits, details of medications, regularity of treatment and biochemical investigations will be filled up at each interview. investigations: initial screening 1. demographic data 2. height, weight, waist and hip measurements. 3. details of family history of diabetes, hypertension and cardiovascular diseases. 4. history of any other major illness. 5. history of blood pressure and measurements. 6. details of education and occupation. 7. diet habits will be analyzed by dietician. 8. details of physical activity will be assessed by a questionnaire. laboratory investigations: 1. initial ogtt 2. plasma glucose and hba1c. 3. lipid profile 4. liver function tests 5. serum amylase and serum lipase 6. plasma insulin 7. 12 lead ecg. review analysis: 1. review will be done with all clinical and biochemical assessment annually. 2. evaluation of adherence to prescription will be done at 6 monthly intervals.

Eligibility criteria:
inclusion criteria: subjects with igt in the age group of 30-55 years (n=900) will be identified by screening with a standard ogtt. exclusion criteria: 1. known diabetes 2. pregnant women 3. alcohol abuse 4. transferable jobs. 5. subjects with major illness like cancer, hepatic or cardiac diseases.

Keywords: sitagliptin type 2 diabetes prevention of type 2 diabetes
oral stereognosis in completely edentulous patient with maxillary tori

Conditions: Torus Palatinus and Torus Mandibularis

Summary: this study aimed to evaluate the oral stereognosis in completely edentulous patients with palatal tori. oral stereognosis is tested using different test specimens in completely edentulous patients with maxillary tori and completely edentulous patients without maxillary tori.

oral stereognosis has been defined as appreciation of the form of objects that is explored intra-orally. in this study the oral stereognosis is determined by placing objects of various shapes in the patient's mouth and having the patient identify the correct form. several studies has proved that oral stereognosis ability (osa) can be used as a predictor for determining the ability of the patients with missing teeth to adapt to a new prosthesis placed in the patient's mouth. maxillary tori is a non-cancerous bony swelling found in palate and have high prevalence among malaysian population. whether osa is higher or lower in patients with maxillary tori is not known.

Eligibility criteria:
inclusion criteria: * complete edentulous patient with maxillary tori and without maxillary tori * complete edentulous patient who were willing give consent and eager to participate exclusion criteria: * patients with swallow and mastication dysfunction * patients with cognitive disturbances * uncooperative patients. * patients with oral lesions, pathologies and tempromandibular joint disorders. * patients with systemic diseases * patients allergic to acrylic resin

Keywords: oral stereognosis completely edentulous
sinefix-2022 comparative phase

Conditions: Rotator Cuff Tears of the Shoulder

Summary: shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. its incidence furthermore is expected to grow as the population ages. a wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full- thickness rotator cuff tears (rcts). the latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the sinefix implant and instruments, are intended. despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. rcts may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however rcts typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative rcts. for rcts, treatment options include both surgical and non-surgical (conservative) procedures. in this context, the sinefix implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction. a pilot study phase investigating the sinefix implant and instruments was conducted and showed adequate performance, usability and preliminary safety. hence, the device is now being tested on a larger number of participants as part of the comparative study phase.


Eligibility criteria:
inclusion criteria: * patient indicated for surgical repair of the rotator cuff tear according to current guidelines * patient aged 18 years or older * up to 2 cm tear size (medio-lateral) of supraspinatus, infraspinatus * up to 2 cm tear size (anterior-posterior) of supraspinatus, infraspinatus exclusion criteria: * subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder * history of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments * inflammatory arthropathies * subject with a contraindication/non-compliance for mri examination * subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule * pregnant and breastfeeding woman
multimodal prognostic system for heart failure: a multi-center study

Conditions: Heart Failure

Summary: this study is a multicenter retrospective research aimed at developing a heart failure prognosis warning system based on multimodal clinical data to improve the diagnosis and treatment of heart failure. this study aims to address the following main questions: 1. what are the clinical characteristics and current treatment status of heart failure patients? 2. what factors influence the onset of heart failure and the prognosis of patients? 3. how can real-world big data be utilized to construct an accurate heart failure prognosis assessment model? 4. how can this prognosis assessment model help improve the therapeutic effects and quality of life for heart failure patients?


Eligibility criteria:
inclusion criteria: age requirement: we plan to include adult patients aged 18 and above to ensure the study covers a broad spectrum of the adult heart failure patient population. diagnostic criteria: patients should have a discharge diagnosis of heart failure according to the guidelines for heart failure diagnosis and treatment. time frame: the discharge time of patients should be between january 2011 and december 2024 to collect and analyze data from the past several years. data integrity: there is a preference for including medical records with high data integrity, but the specific criteria may be adjusted according to the actual situation of the dataset. exclusion criteria: data missing: patients with more than 30% missing data in their medical records may be considered for exclusion to ensure the accuracy and reliability of the analysis. diagnostic inconsistency: patients with unclear diagnoses or potential for confusion with other diseases may be excluded to ensure the specificity of the study. non-standard treatment: patients who have not received treatment according to the established treatment protocol may be excluded to reduce the impact of treatment variability on the study results.
family cardiac caregiver investigation to evaluate outcomes

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: the purpose of the fit-o study was to estimate the prevalence of having a caregiver (paid and/or informal) among hospitalized cardiac patients by demographic factors such as patient age and race/ethnicity, and to link caregiver status to clinical outcomes following hospitalization. a secondary aim was to collect anonymous family tree data to provide an estimate of the number of first degree family members, their basic demographics, and the distance at which they live from the medical center.

it has been established that cardiac caregivers are a vehicle by which health information can be transmitted, and that caregivers themselves may be at increased cvd risk. our research evaluated the potential pool and demographic profile of cardiac caregivers as well as the role(s) they play in improving quality of patient care and to enhance adherence to secondary prevention guidelines post discharge. this research also provided important information about targeting educational efforts to specific caregivers to enhance the clinical outcomes of hospitalized coronary patients. the purpose of this study was to estimate the prevalence of caregiving in hospitalized cardiac patients by demographic factors such as patient age and race/ethnicity, and to link caregiving to clinical outcomes in cardiac patients. a secondary aim was to collect family tree data which would allow us to estimate the number of first degree family members, their basic demographics, and the distance at which they live from the medical center in order to determine the feasibility and scope of a targeted preventive intervention. the significance of this research is that it addressed specific challenges outlined in the recent nhlbi strategic plan to develop and evaluate programs to improve patient, provider, and health care system behavior and performance to enhance quality of care and health outcomes, especially in populations that experience a disproportionate disease burden. unique information was obtained about caregivers as a potential intervention to improve preventive care and health outcomes of patients and families that suffer disproportionate cvd burden. improved adherence to evidence-based preventive therapies could have a substantial public health benefit.

Eligibility criteria:
inclusion criteria: * all inpatients admitted to the cardiovascular service line at columbia university medical center/new york-presbyterian hospital during a consecutive 11-month period will receive a survey as a routine part of hospital admission. exclusion criteria: * inability to read or understand english or spanish. * refusal to complete survey.

Keywords: cardiac caregivers cardiac patient clinical outcomes prevention of cvd
comparison of the effects of erector spinae area (esp) block and thoracic paravertebral block (tpvb) on acute pain, postoperative persistent pain and neuropathic pain in video-assisted thoracoscopic surgery

Conditions: Postoperative Pain

Summary: vats is a minimally invasive approach that allows the introduction of a video camera and surgical instruments into the thoracic cavity through small incisions made in the chest wall. the first thoracoscopy was performed by jacobeus in 1910, and a cystoscope was used in this procedure. over the years, with the development of surgical techniques and technology, the procedures performed using vats have diversified. today, it is used for the diagnosis of pleural diseases and effusions, the staging of lung cancer, lung lobectomies, and the determination of parenchymal diseases. respiratory therapy and pain management after extubation are important issues in postoperative care. adequate postoperative pain control is necessary for a good respiratory effort. the use of intravenous opioids has become the standard in pain management for years. opioids administered to adequately control pain can cause sedation and respiratory depression. due to the large number of opioid-related side effects, alternative pain relief methods are being sought. erector spinae area (esp) block and thoracic paravertebral block (tpvb) have recently been described for the treatment of pain after thoracic surgery. although these blocks have been shown to be effective in the treatment of pain after thoracotomy when compared with systemically administered opioids, they have not been compared in terms of the quality of recovery and postoperative pain after minimally invasive thoracic surgery. the aim of this clinical trial is to compare the effects of erector spinae area (esp) block and thoracic paravertebral block (tpvb) on postoperative acute pain in patients scheduled for vats surgery. the effects of the 2 blocks on postoperative chronic pain and neuropathic pain will also be compared. participants: their pain status will be recorded for 24 hours after spinal surgery when they come for a follow-up visit 3 months after surgery, 2 tests will be performed to check their pain status.


Eligibility criteria:
inclusion criteria: * elective vats surgery performed * asa i-iii * 18-75 years old exclusion criteria: * 1. refusal at enrollment 2. request for withdrawal from the study 3. inability to give informed consent 4. emergency surgery 5. bleeding diathesis 6. presence of contraindications to the la agents used in this study 7. use of chronic opioids 8. psychiatric disorders 9. presence of infection at the injection site

Keywords: postoperative pain