Kornimate/medical-research-clean huggingface dataset:
assessment of feasibility and acceptability of personalized breast cancer screening

Conditions: Breast Cancer

Summary: the overall objective is to assess the acceptability and feasibility of offering personalized breast cancer (bc) screening. the specific objectives are: 1) to design an information system; 2) to evaluate the barriers and facilitators of the coordination of health care services and the screening program; 3) to develop a proof of concept of personalized screening; and 4) to evaluate cost-effectiveness. methodology: 1. prototype information system with basal and longitudinal variables relevant to a personalized screening system; 2. qualitative study with focus groups and survey. the attitude and acceptability on a sample of 210 health professionals will be assessed; 3. prospective observational study, for proof of concept. participants will be professionals working in primary care, population breast screening program, or hospital breast unit. it will include 385 women, aged 40-50 from the city of lleida. various indicators of acceptability and feasibility will be assessed in women and health professionals; 4. probabilistic analytical models will be used to evaluate cost-effectiveness. the present protocol addresses the specific objective number 3, the proof of concept of personalised screening. expected results: the investigators expect to provide valuable and necessary information for the design of personalized screening.


Eligibility criteria:
inclusion criteria: * not having had a mammogram in the last 12 months or with a mammogram in this period available to evaluate breast density. * sign the informed consent. exclusion criteria: * previous diagnosis of breast cancer. * breast study in process. * fulfill clinical criteria defined by the medical oncology spanish society (seom to refer to the genetic counseling unit in cancer. * do not understand or speak catalan or spanish. * cognitive disability for mental or mental illness. * physical disability that prevents a mammogram.

Keywords: personalized early detection screening feasibility acceptability
combined adductor&sciatic nerve block vs femoral&sciatic nerve block in total knee replacement surgery

Conditions: Orthopedic Disorder; Total Knee Replacement; Post Operative Pain; Surgery

Summary: knee joints, one of the largest and most functional joints of the human body, have great features to provide ideal body posture and movement. in patients with knee osteoarthritis in whom pain and functional loss continue to increase despite conservative and medical burden, they are evaluated by orthopedic surgeons for surgical treatment. total knee replacement (tkr) surgery is aimed to eliminate the existing pain, restore and carry the movements, to protect the characteristics of the deformities and the quality of life. pain can be very severe after tkr surgery, which is very common in the middle and elderly patient population today. in the postoperative period, untreated pain prevents early physical therapy practices and restricts postoperative knee rehabilitation and recovery, but it also has negative effects on the respiratory, gastrointestinal, renal, and central nervous systems. effective management of postoperative acute pain can reduce these complications and the risk of developing chronic pain. in this study, investigators hypothesized that combined adductor canal and sciatic nerve block, applied with postoperative ultrasound guidance to patients who will undergo tkr surgery under general anesthesia, will provide effective analgesia, less opioid consumption, and faster ambulation time, similar to combined femoral and sciatic nerve block.

as a result of the power analysis investigators conducted for this study, the minimum sample size was calculated as 34 people for each group, 68 people in total, at the 95% confidence interval. 68 patients who meet the inclusion criteria will be included in our study. patients will be randomized and divided into 2 groups. accordingly, femoral and sciatic nerve blocks will be applied to 34 patients, and adductor canal and sciatic nerve blocks will be applied to 34 patients.

Eligibility criteria:
inclusion criteria: * ages of 40-85 * asa i-iii * patients who will undergo total knee replacement surgery under general anesthesia exclusion criteria: * patients with deformity and pathology in the thigh region * clinically known local anesthetic allergy * clinically diagnosis of opioid, alcohol and substance dependence * patients who cannot perceive and evaluate pain such as psychiatric illness, mental retardation, dementia * morbid obesity (body mass index\> 40 kg m2)

Keywords: femoral nerve block sciatic nerve block adductor canal block general anesthesia orthopedic surgery post operative analgesia
behavioral treatments for acute stress disorder in firefighters

Conditions: Stress Disorders, Post-Traumatic

Summary: this study will develop a treatment for firefighters experiencing symptoms of acute stress disorder (asd). effective treatments may reduce immediate symptoms and prevent the development of more chronic conditions, such as post-traumatic stress disorder (ptsd).

exposure to traumatic events has reached unprecedented proportions in american society, and the rates of ptsd have risen significantly, particularly among populations with repetitive exposure to critical incidents. the continued threat of attacks against americans warrants development of preventive interventions to reduce the occurrence of ptsd and its precursor, asd. this study will determine the effectiveness of a preventive treatment in urban firefighters who have experienced a traumatic event. firefighters will undergo an initial assessment that will include an interview and self-report questionnaires to measure depression, anxiety, coping skills, social support, physical health, and work functioning. following the occurrence of a traumatic work-related event, firefighters will be reassessed. the post-incident assessment will consist of self-report questionnaires that assess asd symptoms. participants who display asd symptoms will be randomly assigned to one of two groups: the first group will learn cognitive behavioral strategies for symptom reduction, and the second group will receive psychoeducation regarding common reactions to traumatic events. participants' treatment will last for 12 weeks. participants will have follow-up assessments 1 and 3 months after the interventional part of the study. assessments will include clinical scales and interviews.

Eligibility criteria:
inclusion criteria: * currently an active duty, nonofficer member of a boston area fire department * willing and able to comply with all study requirements exclusion criteria: * pregnancy or plan to become pregnant during the study * plan to relocate within 2 months of study entry * psychotic symptoms within 30 days prior to study entry * experiencing severe depression at study entry or having suicidal thoughts within 30 days prior to study entry * evidence of severe organic impairment that would interfere with participation in the study * current alcohol or substance dependence * currently awaiting outcome of a court case involving exposure to traumatic events through the fire department

Keywords: ptsd occupational health trauma job cbt
assessment of clinical practice administration of chemotherapy and anti-angiogenic agent (bevacizumab) in colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: investigators propose to assess, retrospectively (from 1/7/2009) and prospectively (up to 31/12/2013,) the safety and tolerability profile (number of participants with adverse events) of standard chemotherapy and anti-angiogenic agent bevacizumab (avastin) as first line treatment of patients with metastatic colorectal cancer with or without kras mutation. all treatment schedules that are going to be assessed are considered by the international guidelines as standard therapy for patients with metastatic colorectal cancer.

in addition investigators propose to assess the compliance of patients to treatment and the efficacy of treatment. that means percentage of objective responses, duration of response, frequency of curative liver resection after the administration of treatment, progression free survival and estimation of overall survival

Eligibility criteria:
inclusion criteria: * written informed consent * histologically confirmed metastatic or locally advanced non-operable colorectal cancer * no prior first line treatment for metastatic colorectal cancer * age ≥18 years * one or more measurable lesions (≥1cm in diameter with spiral ct scan or ≥2cm with conventional techniques) according to recist criteria * ecog performance status ≤2 * adequate haematological, renal and hepatic function * urine protein \<2+ (dipstick) * life expectancy of ≥12 weeks exclusion criteria: * previous first line treatment for metastatic colorectal cancer(progression \>6 months after the end of adjuvant treatment) * previous radiotherapy to target lesions * patients with brain metastases and/or cancerous meningitis * metastatic infiltration \>50% of the liver parenchyma * presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma * patients participating in interventional clinical trial

Keywords: mcrc kras mutation chemotherapy anti-angiogenic agent bevacizumab 1st line
single dose study in subjects with severe hemophilia a comparing pharmacokinetic parameters for bay81-8973 and advate

Conditions: Hemophilia A

Summary: the purpose of this study is to compare the pharmacokinetics of bay81-8973 and advate after intravenous administration.


Eligibility criteria:
inclusion criteria: * males, age 18 to 65 years * subjects with severe hemophilia a with a documented plasma fviii level of \<1% * ≥ 150 exposure days with fviii concentrate(s) as supported by medical records exclusion criteria: * evidence of current or past inhibitor antibody * history of any congenital or acquired coagulation disorders other than hemophilia a * platelet count \<75,000/mm3 * abnormal renal function (serum creatinine \>2 times the upper limit of the normal \[uln\] range) * active liver disease verified by medical history or persistently elevated alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>5 times the uln or severe liver disease as evidenced by, but not limited to any of the following: international normalized ratio (inr) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
effects of sglt2 inhibitor on type 2 diabetic patients undergoing cardiac surgery

Conditions: Diabetes Mellitus, Type 2; Cardiac Surgery

Summary: patients with diabetes have poorer cardiac surgery outcomes compared with non-diabetics. proper blood glucose management is critical to reduce the morbidity and mortality for diabetic patients after cardiac surgery. sglt2 inhibitors including dapagliflozin as a new diabetes drug can reduce heart failure hospitalization rates and overall cardiovascular mortality in patients with cardiovascular disease. this study is to assess the impact of one year of treatment of sglt2 inhibitors on cardiac function, postoperative complications and long-term cardiovascular mortality in diabetic patients undergoing cardiac surgery. the investigators use echocardiography to evaluated cardiac function in diabetic patients during perioperative cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old at index date. 2. diagnosis of type 2 diabetes. 3. scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy). 4. egfr ≥ 60 ml/min/1.73 m2. 5. patients who agree to receive treatment with sglt2 inhibitors. 6. patients must be on current stable hemodynamic profile , without dehydration. exclusion criteria: 1. diagnosis of type 1 diabetes. 2. egfr \< 60 ml/min/1.73 m2. 3. unstable or rapidly progressive renal disease. 4. hypersensitivity to dapagliflozin or any excipients. 5. severe hepatic disease. 6. patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days. 7. any other reason considered by a study physician to be inappropriate for inclusion.

Keywords: diabetes mellitus outcome sglt2 inhibitors cardiac surgery
effect of schisandra chinensis extract on musculoskeletal biomakers in relatively sarcopenic adults: a rct

Conditions: Muscular Sarcoidosis

Summary: the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the sce on muscle strength, muscle mass, and muscle function in healthy adults for 12 weeks.

previous studies have indicated that schisandra chinensis extract (sce) may have the ability to prevent skeletal muscle atrophy. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the sce on muscle strength, muscle mass, and muscle function in healthy adults; the safety of the compound are also evaluate. the investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 4 and 12 weeks of intervention. fifty-four healthy adults were administered either 1,000 mg of sce or a placebo each day for 12 weeks;

Eligibility criteria:
inclusion criteria: * \<110% of the standard lean body mass as measured using the body composition analyzer inbody 720) * body-mass index (bmi) ranging from 18.5 to 30.0 kg/m2 exclusion criteria: * abnormal liver or renal function (i.e., serum aminotransferase activity \> 60 iu/l and serum creatinine concentrations \> 1.2 mg/dl) * diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dl) * history of fracture during the previous year * uncontrolled hypertension * history of serious cardiac disease such as angina or myocardial infarction * history of gastrectomy * history of medication for psychiatric disease * administration of oriental medicine including herbs within the past 4 weeks * evidence of relatively high skeletal mass (more than 110% of the standard lean body mass as measured using the body composition analyzer inbody 720)
evaluating the effects of tasimelteon vs placebo on sleep disturbances in sms

Conditions: Smith-Magenis Syndrome; Circadian

Summary: the aim of this study is to investigate tasimelteon vs. placebo on sleep disturbances of individuals with smith-magenis syndrome.


Eligibility criteria:
inclusion criteria: 1. a confirmed clinical diagnosis of sms 2. informed consent from the patient or the legal guardian 3. male or female between the ages of 3- 65 years of age 4. recent history of sleep disturbances 5. have an appointed care-giver complete the required outpatient assessments 6. willing and able to comply with study requirements and restrictions exclusion criteria: 1. unable to dose daily with medication 2. exposure to any investigational drug, including placebo, within 30 days or 5 half-lives (whichever was longer) of screening 3. any other sound medical reason as determined by the clinical investigator

Keywords: sms
psychological intervention for relapse prevention in first episode schizophrenia

Conditions: Schizophrenic Disorders

Summary: the study is a randomized clinical trial investigating the efficacy of a comprehensive psychological intervention for the treatment of first episode schizophrenia

patients suffering from their first episode of schizophrenic disorders are randomly allocated to either a short "information centered psychoeducation" (icp) of 8 sessions or a "cognitive behavioral treatment" (cbt). cbt includes 8 sessions of psychoeducation, 8 sessions of computer based cognitive training, 8 sessions with relatives and 20 sessions of focusing on stress management, relapse prevention and coping with persistent symptoms. the primary endpoint is relapse at the one and two year follow up.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenic disorder according to icd 10: f20 * first episode * age between 18 and 55 * willingness to give informed consent also to a double blind pharmacological treatment study exclusion criteria: * residence outside of the catchment area * insufficient knowledge of the german language * substance abuse or addiction as primary clinical problem * serious physical illness * organic brain disease * pregnancy * contraindications to neuroleptic treatment

Keywords: schizophrenia, first episode, cognitive behavioural therapy, psychoeducation
wingspan stenting for symptomatic severe stenosis of intracranial atherosclerosis registry in china

Conditions: Intracranial Atherosclerosis

Summary: this is a prospective, multi-center, non-randomized trial to study one-year outcomes of the wingspan system for the treatment of chinese patients with symptomatic atherosclerotic severe intracranial stenosis.

the study will enroll 200 chinese patients with atherosclerotic intracranial stenosis of 70% to 99% that causes a recent ischemic neurologic event. the winspan stenting following undersized gateway balloon angioplasty will be performed at experienced centers (at least 10 cases' experiences of using the wingspan system to treat the patients with intracranial stenosis for each center). the primary endpoint of the study, independently evaluated by neurologists, is any stroke or death within 30 days, plus ischemic stroke in the stented artery territory between 31 day and 1 year.

Eligibility criteria:
inclusion criteria: * an angiographically verified ≥ 70% stenosis of a major intracranial artery that causes tia or minor stroke (nih stroke scale score \<9) within 90 days; * the lesion length \<15 mm and normal arterial diameter adjacent to it between 2.0 mm and 4.5 mm; * patients having at least one atherosclerotic risk factor (arterial hypertension, diabetes mellitus, hyperlipidemia, hyperhomocysteinemia and cigarette smoking). exclusion criteria: * non-atherosclerotic stenosis; * intracranial hemorrhage in the territory of the stenotic artery within 6 weeks; potential source of cardiac embolism; * concurrent intracranial tumor, aneurysm and cerebral arteriovenous malformation; * tandem \>50% stenosis of extracranial carotid or vertebral artery; known contraindication to heparin, aspirin, clopidogrel, anesthesia and contrast media; hemoglobin \<10 g/dl, platelet count \<100,000; * international normalized ratio \>1.5 (irreversible) and uncorrectable bleeding diathesis; and life expectancy \<1 years because of other medical conditions.

Keywords: atherosclerosis intracranial artery angioplasty stent
handgrip exercise for arteriovenous fistula maturation

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to investigate whether post operative progressive forearm exercise is effective in improving arteriovenous fistula maturation in chronic kidney disease patients.

the arteriovenous fistula is considered to be the gold standard form of access for haemodialysis patients, however only 37% of haemodialysis patients have this form of access. a possible explanation for this could be the high fistula failure rate due to the lack of maturation. therefore interventions aimed at enhancing fistula maturation are warranted. one such intervention could be forearm exercise, however this recommendation is not evidence based. therefore, the purpose of this study is to investigate whether a program of post operative progressive hand grip exercise can improve fistula maturation.

Eligibility criteria:
inclusion criteria: * stage 4-5 chronic kidney disease, attending for arteriovenous fistula creation in forearm exclusion criteria: * are under the age of 18years; * not able to exercise forearm safely (as decided by the patients consultant) * have any other uncontrolled medical condition * unable to withstand transiently raised systolic blood pressure by 35 mmhg and diastolic by 25 mmhg * or are unable to give consent

Keywords: exercise; arteriovenous fistula; chronic kidney disease
postoperative pain after breast surgery under tumescent local anaesthesia versus general anaesthesia ( tla-001 )

Conditions: Breast Carcinoma; Breast Carcinoma in Situ

Summary: the present study aims to investigate the impact of tumescent local anesthesia (tla) on pain perception following surgeries typical for breast cancer. previous research has already confirmed the feasibility of conducting operations in tla for benign breast conditions. in contrast to general anesthesia, tumescent local anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. additionally, if needed, sedatives or further anesthesia can be administered through the vein. building upon the successful applications of tla in benign breast surgeries, this follow-up study at the department of women's health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. simultaneously, our goal is to gather scientific data regarding the application of this technique. this research contributes to the continuous advancement of medical practices in the field of breast surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 years * written informed consent * histologically confirmed breast carcinoma or pure ductal carcinoma in situ * planned operation: * segmental resection/ breast-conserving surgery * segmental resection/ breast-conserving surgery with snb * ablatio * ablatio with snb/ axilla exploration exclusion criteria: * expected lack of patient compliance or inability of the patient to understand the purpose of the study * lack of patient consent * pregnancy * complete axillary dissection * tumour-adapted reduction surgery, implant reconstructions * surgeries where technical difficulties are expected under any anaesthesia (e.g. asa iv, bmi \> 40) * bilateral breast operations * men exclusion criteria for surgery in tla: * injection phobia * psychoses/ previous psychological illnesses * advanced dementia * language barrier
relevance and efficiency of second line workup for uveitis

Conditions: Uveitis

Summary: the first-line etiological workup is currently poorly codified, and some patients undergo sequential investigations. however, the reason which lead the clinician to perform subsequent exams, and the relevance of such exams, remain to be determined. the main objective of the study was to assess the relevance of a second-line workup of patients with uveitis.

the first-line etiological workup is currently poorly codified, with some patients undergoing extensive investigations, and other minimal etiological workup. in addition, some patients undergo sequential investigations. however, the reason which lead the clinician to perform subsequent exams, and the relevance of investigations performed after a first line workup remain to be determined. the main objective of the study was to assess the relevance of a second-line workup of patients with uveitis.secondary objectives were to describe the reasons of these second-line workups, and to determine which exams were the most relevant, and the determinants of its realization.

Eligibility criteria:
inclusion criteria: * adult patient * at least one etiological workup in our center exclusion criteria: * only episode of acute anterior uveitis quickly responding to topical treatments * diagnostic ophthalmologically obvious * opposition to collection of data