Kornimate/medical-research-clean huggingface dataset:
a patient navigation intervention for the improvement of risk management among women at high risk of breast cancer

Conditions: Breast Carcinoma

Summary: this clinical trial studies whether a patient navigation (pn) intervention can be used to improve risk management among women at high risk of breast cancer. women with a family history of breast cancer have a higher lifetime risk of developing it. risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. pn is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. the pn intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.

primary objective: i. test the feasibility of the pn intervention and of recruiting participants to a randomized controlled trial of the intervention. outline: participants are randomized to 1 of 2 arms. arm i: participants receive links to informational websites on breast cancer risk and risk management options on study. participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. participants may choose to receive additional patient navigator phone calls as needed on study. arm ii: participants receive links to informational websites on breast cancer risk and risk management options on study. after completion of study intervention, participants are followed for up to 1 month.

Eligibility criteria:
inclusion criteria: * are non-hispanic black or non-hispanic white * identify as women * are between 18 and 75 years old * have been identified as at potentially high risk by a population-based risk screening program * have never been diagnosed with breast or ovarian cancer * are early in their risk-management adoption process, defined as currently identifying with stage 0 (never heard of it) or 1 (haven't decided) of the risk-management adoption pathway (r-map) in relation to at least one of the four risk-management actions recommended for all high-risk women: attending genetic counseling appointment, having a personalized risk assessment, undergoing annual clinical breast exams, and considering chemoprevention * who do not believe cancer can be prevented and/or have not received risk-management guidance from a specialist
illness expectations in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study investigates the impact of expectations on individuals with chronic obstructive pulmonary disease (copd) and aims to develop and validate a novel tool to assess these expectations. by understanding the role of expectations, healthcare providers can better tailor interventions and support for copd patients, ultimately improving their quality of life and treatment outcomes.

this research, carried out at the specialized cardiorespiratory rehabilitation unit of the don gnocchi foundation in milan, delves into the influence of expectations on individuals living with chronic obstructive pulmonary disease (copd). the primary objective is to craft and validate a fresh assessment tool to gauge these expectations. moreover, the questionnaire is reintroduced to patients after a month, during which additional data, as detailed in the corresponding section, are gathered.

Eligibility criteria:
inclusion criteria: * diagnosis of copd confirmed by spirometry * adults * italian speakers * ability to complete the required tests * informed consent from the patient to participate in the study exclusion criteria: * non-italian speakers * psychiatric comorbidities * cognitive impairment

Keywords: chronic obstructive pulmonary disease clinical psychology rehabilitation psychology chronic illness
initiation of continuous glucose monitoring in adults with type 2 diabetes treated with basal insulin, in italy

Conditions: Type 2 Diabetes Treated With Insulin

Summary: the goal of this clinical study is to determine the impact of starting the use of the freestyle libre 2 glucose monitoring system, over a three month period, on hba1c in adults with type 2 diabetes treated with a basal insulin regimen.

this is a post-market, multi-centre, prospective, interventional single arm study in italy. participants will use the freestyle libre 2 flash glucose monitoring system, according to the labelling, to monitor their glucose for approximately 3 months. additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance. hba1c will be tested at the start and end of the study for primary endpoint analysis.

Eligibility criteria:
inclusion criteria: * aged ≥18 to ≤ 75 years. * type 2 diabetes diagnosis ≥1 year prior to enrolment. * type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment. * current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment. * screening hba1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days. exclusion criteria: * participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment. * currently participating in another study that could affect glucose measurements or glucose management. * currently receiving dialysis treatment or receives dialysis during the study. * a female participant who is pregnant. * a breastfeeding female participant.
effect of a combination of local steroid injection with oral steroid administration for the prevention on esophageal stricture after endoscopic submucosal dissection for early esophageal neoplasm

Conditions: Esophageal Stricture

Summary: the method of esophageal endoscopic submucosal dissection (esd) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in asian countries. however, besides of perforation and bleeding, another complication postoperative esophageal stricture is frequently observed after the removal of large-sized esophageal neoplasms by esd. dysphagia caused by postoperative stricture substantially decreases the patient's quality of life, requiring further therapy. although the exact incidence is unknown, esophageal stricture is supposed to be related to the extent of the circumference being resected. in previous study by ono et al，it is reported that 90% of patients with lesions of circumferential extension of more than three-fourths experienced postoperative stricture after esophageal esd. there were some reported studies exploring new ways to prevent esophageal stricture after esd, such as oral prednisolone and local corticosteroid injection. corticosteroids can inhibit not only collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture formation. some studies reveled that just oral prednisolone oral is effective option for the prevention of post-esd stricture. however, most of the reported studies were non rcts with small sample. in the primary study, the investigators search a new method of combination of both oral and local injection to prevent esophageal stricture，as a result，stricture at 8 weeks after esd was found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the corticosteroid group. unfortunately，the study was also retrospective. so, the investigators plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic effects of combination of local steroid injection with oral steroid administration for esophageal stenoses complicating extensive esd.


Eligibility criteria:
inclusion criteria: 1. patients who has undergone esophageal esd 2. histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus 3. esd resulted in a mucosal defect involving more than two-thirds of the esophageal circumference. exclusion criteria: 1. severe circulatory or respiratory disease，severe renal impairment 2. women in pregnancy and lactation 3. patients with steroid contraindications 4. patients refuse to join in this study

Keywords: esophageal stricture endoscopic submucosal dissection prevention
gait modification treatment for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (oa) is a costly health condition affecting more than 10% of canadian adults. excessive and unbalanced loads passing through the knee joint have been implicated in the progression of oa. typical conservative treatment of oa has focused on increasing daily activity, without consideration for the underlying joint loading. this study aims to compare a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during walking - a measure shown to reduce joint loading and oa disease progression - while increasing walking time/distance, with a standard walking program that aims to increase walking time/distance. it is predicted that the walking program focusing on increasing toe-out will provide greater reductions in self-reported knee pain and a greater reduction in unfavorable knee joint loading.


Eligibility criteria:
inclusion criteria: * aged 50 years and older * radiographically confirmed medial compartment tibia-femoral knee osteoarthritis * available for weekly training sessions in the vancouver british columbia canada region * able to safely perform treadmill walking under therapist supervision exclusion criteria: * articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial * inflammatory arthritic condition * history of knee replacement or arthroscopic knee surgery * recent use of corticosteroids (oral or via injection) * inability to ambulate without a gait aid * non-english speaking * planning to commence a new treatment approach within the next 4 months

Keywords: osteoarthritis knee walking toeout gait modification
cox-2 inhibitor study in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this study is being conducted to find out if an investigational drug called gw406381 can help people with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis (ra) for at least 12 months. * required a non-steroidal anti-inflammatory drug (nsaid) or cox-2 inhibitor for ra for at least 5 out of 7 days of each week for the 4 weeks prior to screening. exclusion criteria: * any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism. * have an active stomach ulcer or history of any stomach tear or bleeding.

Keywords: rheumatoid arthritis cox-2 inhibitor
a dose response study of dabigatran etexilate(bibr 1048) in pharmacodynamics and safety in patients with non-valvular atrial fibrillation in comparison to warfarin

Conditions: Atrial Fibrillation

Summary: the primary objective was to evaluate the safety of dabigatran etexilate(bibr 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.


Eligibility criteria:
inclusion criteria inclusion criteria 1. patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) 2. patients who had additional risk factor for thromboembolism; one or more of the following conditions/events: * hypertension * diabetes mellitus * left-side heart failure * a previous ischemic stroke or transient ischemic attack * age 75 years or older * a history of coronary artery diseases exclusion criteria exclusion criteria 1. patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery 2. patients who were to receive electric defibrillation or pharmacological defibrillation during the study period 3. patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent 4. patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent 5. patients with atrial myxoma or left ventricular thrombosis 6. patients with contraindication to anticoagulant therapies 7. patients scheduled for major surgery or invasive procedure 8. patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent 9. patients with uncontrolled hypertension
study of the symptomatic improvement in patients with fibromyalgia by means of a food supplement

Conditions: Fibromyalgia

Summary: fibromyalgia is a syndrome (set of symptoms) of unknown etiology and characterized by diffuse musculoskeletal pain and chronic fatigue. in addition, other symptoms such as cognitive alterations, sleep rhythm disturbances, psychiatric syndromes such as anxiety, depression, etc. other very characteristic symptoms are hyperalgesia (very low pain threshold) and allodynia (amplified response to painful stimuli). the treatment of fibromyalgia is symptomatic and the drugs only serve to reduce symptoms in some patients, in addition to the fact that these available treatments (antidepressants, pain signal modulators, rescue analgesics, etc.) have many side effects. the food supplement which is the object of this study, fibrofixplus®, is made up of a combination of natural substances. this is the reason why this observational study aims to improve symptoms caused by fibromyalgia in patients treated with fibrofixplus®.

patients who meet the fibromyalgia criteria according to the definition of the american college of rheumatology (acr) in 1990 and 2010, with a minimum score of 4 on the visual analogue scale (vas) of fatigue and pain and without any treatment (anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics) in a minimum of 4 weeks prior to the beginning of the study, with some exceptions, and who do not meet any of the exclusion criteria will be invited to participate in the study. there are three study visits which are distributed throughout 8 weeks.

Eligibility criteria:
inclusion criteria: * women ≥ 18 years. * meet the fibromyalgia criteria according to the definition of the american college of rheumatology of 1990 and 2010. * minimum score of 4 on the visual analogue scale (vas) for fatigue and pain. * period prior to the start of the study of a minimum of 4 weeks without treatment with anxiolytics, neuroleptics, antidepressants and/or narcotic analgesics. the use of paracetamol up to 2 g/day is allowed, and tramadol 100 mg/8h maximum. exclusion criteria: * current diagnosis of a psychiatric disorder other than major depressive disorder. * pain caused by a traumatic or structural injury. * chronic inflammatory diseases. * autoimmune disease. * use of medications that may interfere with the assessment of pain improvement, including analgesics (with the exception stated in the inclusion criteria), antidepressants, anticonvulsants, or other medication taken to combat fibromyalgia, fatigue or pain. * rehabilitation with therapeutic intent. * intent to apply or current disability application process. * natural therapies (homeotherapy, acupuncture, food, etc.) to improve fibromyalgia. * hypersensitivity to the active principles or to any of the excipients of the products included in the study. * pregnancy. * breastfeeding.
improving venous thromboembolism prophylaxis

Conditions: Venous Thromboembolism; Delivery of Health Care; Quality Improvement

Summary: preventing the formation of blood clots in the veins so they do not injure leg veins or travel to the lungs, also called venous thromboembolism prophylaxis (vte-p) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including the investigators own. two prior vte-p improvement projects were completed at mayo clinic hospitals, one in the department of medicine, and the other in selected divisions of the department of surgery. both projects resulted in marked improvement in the percentage of patients receiving appropriate vte-p. this project seeks to utilize the lessons learned from these two pilots along with known best practices for \&quot;spreading\&quot; to deploy methods that enhance vte-p to the entire hospitalized population. the investigators seek appropriate vte-p rates exceeding 95%.

venous thromboembolism prophylaxis (vte-p) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including our own. two prior vte-p improvement projects were completed at mayo clinic hospitals, one in the department of medicine, and the other in selected divisions of the department of surgery. both projects resulted in marked improvement in the percentage of patients receiving appropriate vte-p. this project seeks to utilize the lessons learned from these two pilots along with known best practices for \&quot;spreading\&quot; to deploy methods that enhance vte-p to the entire hospitalized population. the investigators seek appropriate vte-p rates exceeding 95%. this began as a quality improvement project. the investigators have taken baseline measures of vte-p rates in our hospitals, intervened with various electronic prompts to use appropriate vte-p, and have and will re-measure vte-p rates. the investigators intend to present and publish our methods and results so that lessons learned may be shared and applied elsewhere.

Eligibility criteria:
inclusion criteria: * inpatients with age \> 17 years old exclusion criteria: * outpatients * inpatients with age less than or equal to 17 years old

Keywords: venous thromboembolism delivery of health care quality improvement evidence-based practice
pancreatic fistula after minimally invasive enucleation

Conditions: Pancreatic Tumor, Benign; Pancreatic Neuroendocrine Tumor; Solid Pseudopapillary Tumor of the Pancreas

Summary: patients suffering from postoperative pancreatic fistula (popf) after minimally invasive enucleation (mien) show a characteristic pattern of longer duration and milder symptoms, which is different from pancreatic fistula after standard pancreatectomy. this study aimed to analyze the factors influencing clinically-relevant popf (cr-popf) after mien, investigate and develop a personalized predictive model for accurate prediction of cr-popf.

minimally invasive enucleation (mien) has been widely used in managing benign and low-grade malignant pancreatic tumors, showing better protection of pancreatic function and better long-term outcomes compared to standard pancreatectomy. however, the incidence of postoperative pancreatic fistula (popf) after mien is higher compared to standard resection, mainly since a large part of the pancreatic wound is exposed, and the main pancreatic duct may be exposed or injured, etc. popf is the most important postoperative complication, and it has become a major constraint to the conduct of pancreatic mien. although risk factors and predictive models for popf in standard pancreatic surgery have been reported in the past, no predictive models have been reported specifically for men. with the increasing adoption of mien, there is an urgent need for a predictive model to guide the treatment and prognosis of popf. therefore, this study aims to conduct a cohort study, with data prospectively collected and retrospectively analyzed. the result of this study will provide a valuable reference for the development and application of mien.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 years, regardless of gender. 2. benign or low-grade malignant tumor of the pancreas. 3. patients evaluated according to guidelines that indicate a need for surgery or a strong request for surgery. 4. feasibility of performing minimally invasive pancreatic tumor enucleation based on preoperative imaging evaluation. 5. patients with an eastern cooperative oncology group (ecog) performance status of 0 or 1. 6. willingness to comply with the follow-up programme of the study and other protocol requirements. 7. voluntary participation and signed informed consent. exclusion criteria: 1. concurrent presence of other malignant tumors. 2. intraoperative frozen pathology or postoperative pathology indicating the tumor to be malignant, requiring oncological resection instead. 3. severe impairment of cardiac, hepatic, or renal function (e.g., nyha class 3-4 heart failure, alt and/or ast levels exceeding three times the upper limit of normal, creatinine levels exceeding the upper limit of normal). 4. missing data due to patient loss of followup, etc.

Keywords: pancreatic benign or low-grade malignant tumors minimally invasive enucleation postoperative pancreatic fistula prediction model
sarcopenic index and related factors in patients with type 2 diabetes

Conditions: Type 2 Diabetes; Sarcopenia

Summary: sarcopenia, characterized by a progressive loss of skeletal muscle mass and function, is particularly common in individuals with t2dm and is often associated with insulin resistance, chronic inflammation and oxidative stress. the sarcopenia index (si), calculated as serum creatinine divided by serum cystatin c, is a practical tool for assessing sarcopenia and is used in many clinical settings. in this study, we aimed to investigate the relationship between sarcopenic index and variables such as age, diabetes duration, diabetes control and complication-related parameters such as nt-probnp and fib4 score in patients with type 2 diabetes.

this study was planned retrospectively. between september 01, 2023 and march 31, 2024, the records of patients who presented to the diabetes outpatient clinic of goztepe prof. dr. suleyman yalcin city hospital for internal medicine and whose routine biochemical tests (including nt-probnp and cystatin c) were found in the system will be retrospectively reviewed. both male and female patients with a definite diagnosis of type 2 diabetes were included in the study. inclusion criteria included: age 40 years or older, age 85 years or younger, no acute infection, no steroid use, no acute changes in creatinine or cystatin c levels, no recent surgery, no limb loss. demographic data included age, gender, duration of diabetes, medications and concomitant diseases. the fib 4 score was calculated using the patients' routine biochemical and hematologic results. the sarcopenia index was calculated from the serum creatinine/cystatin c values. a cut-off value of 0.90 is normally used for the diagnosis of sarcopenia in people without diabetes, but there is no cut-off value for patients with diabetes. therefore, in addition to the correlation, the si value was divided into 3 groups and the patients in the lowest and highest groups were compared with each other.

Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosis * with complete biochemical data on record exclusion criteria: * acute infection, * steroid use, * acute changes in creatinine or cystatin c levels, * recent surgery, * limb loss.

Keywords: type 2 diabetes sarcopenic index cystatin c