Kornimate/medical-research-clean huggingface dataset:
improving therapeutic ratio with hypo fractionated stereotactic radiotherapy for brain metastases

Conditions: Brain Metastases

Summary: randomized phase ii trial. the study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. the current standard of stereotactic radiotherapy (srt) in one or three fractions is compared to fractionated stereotactic radiotherapy (fsrt) in five fractions.

randomized phase ii trial. stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. there are an increasing number of long term survivors. brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fsrt, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. in this trial, one group is treated with srt in one or three fractions. the other group is treated with fsrt in five fractions. survival, toxicity and patient reported quality of life are monitored.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * at least one brain metastasis of large cell cancer suitable for srt * karnofsky performance status ≥ 70 * ability to provide written informed consent * new brain metastases during follow-up after surgery allowed (when outside of resection cavity area) * new brain metastases during follow-up after previous srt allowed (when outside of previous irradiation field) exclusion criteria: * contra-indication for mri scan * primary tumor of small cell lung cancer, germinoma or lymphoma * prior whole brain radiotherapy or srt on the current target brain metastases (in field re-irradiation) * presence of leptomeningeal metastases * previous inclusion in the safestereo study

Keywords: fractionated stereotactic radiotherapy
kinetic chain approach for rotator cuff tendinopathy

Conditions: Rotator Cuff Tendinopathy

Summary: the aim of this research is to determine the effectiveness of the kinetic chain approach on pain, functional disability and kinesiophobia in patient with rotator cuff tendinopathy. randomized controlled trials done at national institute of rehabilitation and medicine. the sample size was 44. the subjects were divided in two groups, 22 subjects in group a that received conventional treatment and 22 subjects in group b that received kinetic chain approach and conventional treatment. study duration was of 6 months. sampling technique applied was non probability connivance sampling technique. patient with age between 40 to 65 years, clinically diagnosed and patients who meet the diagnostic criteria ≥ three positives in five shoulder impingement tests: neer's sign, hawkins and kennedy test, empty can test, painful arc of abduction, and external rotation (er) resistance test, patients in acute (4 weeks) and sub-acute stage (4-6 weeks).patients with positive scapular assistance test (sat) and scapular retraction test (srt). were included. tools used in the study are nprs (numeric pain rating scale). spadi (shoulder pain and disability) .tampa scale for kinesiophobia tsk-11. data was be analyzed through spss -25


Eligibility criteria:
inclusion criteria: * both male and female. * age between 40 to 65 years. * clinically diagnosed and patients who meet the diagnostic criteria ≥ three positives in five shoulder impingement tests: neer's sign, hawkins and kennedy test, empty can test, painful arc of abduction, and external rotation (er) resistance test (14) * patients in acute (4 weeks) and sub-acute stage (4-6 weeks). * patients with positive scapular assistance test (sat) and scapular retraction test (srt). exclusion criteria: * patients with cervical radiculopathy or previous shoulder surgery. * any participants with a full thickness tear of rotator cuff tendon. * history of glenohumeral dislocation, or other traumatic injury to the shoulder * diagnosed patients of rheumatoid arthritis and osteoarthritis. * hemiplegia affecting the shoulder and lower extremity * a complex myofascial pain syndrome. * history of significant lower extremity problems, including severe joint pain, recent fractures, or major musculoskeletal disorders (e.g. chronic ligament injuries)

Keywords: rotator cuff injury kinetic chain approach pain functional disability kinesiophobia
clinical outcomes of contemporary impella devices in cardiogenic shock and high-risk percutaneous coronary intervention

Conditions: Cardiogenic Shock; PCI Patients; Mechanical Circulatory Support

Summary: the immerge registry is an observational, international multicentric study, including patients underwent impella implantation in the participating centers both for cardiogenic shock and high-risk pci. only impella cp, 5.0 and 5.5 devices will be included. consecutive patients with cs and chips implanted with impella® cp, 5.0 and 5.5 with at least 6 months of follow-up completed will be enrolled in the registry. baseline clinical and echocardiographic variables, peri-procedural haemodynamic parameters, laboratoristic findings and complications, together with follow-up outcomes data will be recorded in a dedicated database.


Eligibility criteria:
inclusion criteria: * males or females ≥ 18 years-old with cs or chips * impella® device implanted (cp, 5, 5.5) exclusion criteria: * age \< 18 years * no impella implanted

Keywords: impella cardiogenic shock complex pci
deploying novel imaging modalities towards a three-dimensional (3d) cardiovascular pathology

Conditions: Coronary Artery Disease; Aortic Valve Disease; Aortic Valve Calcification; STEMI; Cardiovascular Pathology

Summary: the goal of the 3d-cardiopath study is to investigate the potential added value of emerging 3d imaging modalities by imaging ex vivo cardiac specimens (diseased coronary arteries, calcific aortic valves, and thrombotic materials) in 3d. specifically, 20 cadaveric coronary artery segments with advanced atherosclerosis will be received from 10 patients with scd. these segments will first be scanned with intravascular imaging modalities, namely optical coherence tomography (oct) and intravascular ultrasound (ivus), and then with micro-computed tomography (micro-ct) and light sheet fluorescence microscopy (lsfm). additionally, 30 thrombotic specimens aspirated from patients with st-elevated myocardial infarction, will also be scanned using micro-ct. finally, 30 surgically removed aortic valves will undergo scanning with micro-ct and lsfm. traditional histopathological assessment will also be performed on the scanned specimens. patient laboratory profiles, past medical histories, demographic characteristics, and therapeutic management will be recorded, where applicable.

the 3d-cardiopath study aims to provide 3d volumetric insights into well-characterized disease entities such as coronary artery disease (cad) and calcific aortic valvular disease (cavd). therefore, this study aims to visualize in 3d: 1. cadaveric coronary artery samples collected from adults with sudden cardiac death (scd); 2. thrombotic specimens aspirated during percutaneous coronary intervention (pci) procedures in patients with st-elevated myocardial infarction (stemi); and 3. calcific aortic valves surgically removed from patients with cavd undergoing cardiac surgery for valve replacement. the utilized 3d imaging means will be: 1. optical coherence tomography (oct), intravascular ultrasound (ivus), micro-computed tomography (micro-ct) and light sheet fluorescence microscopy (lsfm) for the assessment of the collected cadaveric coronary arteries; 2. micro-ct for the assessment of the aspirated thrombotic material 3. lsfm and micro-ct for the assessment of the resected aortic valves. finally, the scanned specimens will be histopathologically assessed at the first department of pathology in athens, greece by experienced pathologist.

Eligibility criteria:
inclusion criteria: * age \>18 years. * patients with sudden cardiac death for coronary artery imaging. * patients with stemi undergoing pci and thrombus aspiration for thrombus imaging. * patients with cavd undergoing cardiac replacement of calcific aortic valve for valve imaging. exclusion criteria: * patients dying after the execution of their cardiac surgery. * patients with altered mental status; unable or unwilling to provide informed consent for specimen imaging and clinical follow-up.

Keywords: micro-ct light sheet fluorescence microscopy intravascular ultrasound optical coherence tomography 3d cardiovascular imaging 3d cardiovascular pathology
investigation of clot in ischemic stroke and hematoma evacuation

Conditions: Ischemic Stroke; Intracranial Hematoma

Summary: the aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * frontline treatment with: penumbra system for ischemic stroke patients eligible for mechanical thrombectomy or artemis neuro evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (mis) * extracted thrombus/embolus * informed consent is obtained from either the patient or legally authorized representative (lar) exclusion criteria: * pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable) * currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
the effect of fesoterodine on pharmacokinetics and pharmacodynamics of warfarin in healthy subjects

Conditions: Urinary Bladder, Overactive

Summary: this is an open-label, randomized, two-way crossover study to evaluate the steady-state effect of fesoterodine (8 mg qd) on the pharmacodynamics and pharmacokinetics of a single supratherapeutic dose of warfarin (25 mg) in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years exclusion criteria: * not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality

Keywords: overactive bladder urgency frequency
the effect of mobile online training applied to patients with diabetes on insulin therapy

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study aims to investigate the effect of health belief model-based mobile online training applied to patients with diabetes on insulin therapy.

intervention and control group participants were invited to the endocrinology and metabolic diseases outpatient clinic for a pre-test. n addition, each group was given insulin injection practice training using an insulin injection model. whether the application was correct, incomplete, or incorrect was recorded on the observation form by the diabetes nurse. the web-based "insulin guide" mobile application prepared by the researcher was installed on the phones of the intervention group participants. they were asked to use this application for three months, at least three hours a week. participants were followed up through the application. participants who did not use the application were informed by sms or phone and asked to use the application. participants who did not use the application were excluded from the study. no intervention was made for the control group participants. at the end of three months, the participants in the intervention and control groups were invited to the endocrinology and metabolic diseases outpatient clinic for a post-test. both groups were asked to practice again on the insulin injection model. whether the application was correct, incomplete, or incorrect was recorded on the observation form by the diabetes nurse.

Eligibility criteria:
research inclusion criteria * type 1 dm * type 2 dm (diagnosed at least six months ago) * patients receiving insulin therapy * patients in the 18-65 age group * literate patients * patients, or patients with a relative, who has an electronic device such as a smartphone, computer, etc. that can connect to the internet. * patients who have no psychiatric illness or communication barrier (visual, auditory, and speech disability) * individuals who agreed to participate in the research. research exclusion criteria * patients who receive treatment with oral anti-dm only * patients who use an insulin pump * patients who quit the training. * patients who had a change in treatment * patients who traveled to a place that cannot provide an internet connection

Keywords: diabetes web-based mobile training insulin therapy insulin self-management insulin injection skill health belief model
a study of pf-05082566 as a single agent and in combination with rituximab

Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Carcinoma, Squamous Cell of Head and Neck; Malignant Melanoma

Summary: a study of pf-05082566, a 4-1bb agonist monoclonal antibody (mab), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with cd20 positive non-hodgkin's lymphoma (nhl).


Eligibility criteria:
inclusion criteria * portion a: histological or cytological diagnosis of advanced/metastatic solid tumor malignancy or b cell lymphoma, for which no curative therapy is available. portion a expansion includes patients who have documented disease progression on a checkpoint inhibitor (anti ctla 4, anti pd1/pd l1 antibodies) per recist criteria. tumor types include metastatic melanoma, renal cell carcinoma (rcc), non-small cell lung cancer (ncslc) and squamous cell carcinoma of the head and neck (scchn). patients in the dose expansion stage are required to provide archival or baseline (obtained during the screening period) tumor biopsies. * portion b: histological confirmed relapsed or refractory cd20 positive nhl for which no curative therapy is available. patients enrolled in the expansion cohort must have archival tissue available, sampled within 6 months of study entry. the expansion cohort includes patients with fl or dlbcl with relapsed or refractory disease. * measurable disease with at least one extranodal tumor mass \>1.0 cm in the greatest transverse diameter (gtd) or in the case of malignant lymph nodes \>1.5 cm in the gtd. * ecog performance status of ≤ 1. * adequate bone marrow function, for portion a: absolute neutrophil count (anc) ≥ 1.5 x 109/l, platelet count ≥100 x 109/l, hemoglobin \>9.0 g/dl. for portion b: anc ≥ 1.0 x 109/l, platelet count ≥ 75 x 109/l, and hemoglobin ≥ 8.0 g/dl. in both cases, patients must be transfusion independent at least 14 days prior to screening. * serum creatinine ≤ 2 x uln or estimated creatinine clearance ≥ 50 ml/min. * total serum bilirubin ≤ 1.5 x uln unless the patient has documented gilbert syndrome and ast and alt ≤ 2.5 x uln. exclusion criteria * patients with known symptomatic brain metastases requiring steroids. * prior allogeneic hematopoietic stem cell transplant. * immunosuppressive regimens involving systemic corticosteroids within 14 days before the first dose of study treatment. * therapeutic or experimental monoclonal antibodies within 28 day or prior radiation therapy within 14 days of the first dose of study drug. * autoimmune disorders and other diseases that compromise or impair the immune system. * unstable or serious concurrent medical conditions in the previous 6 months. * prior therapy with any anti cd137 monoclonal antibody.

Keywords: phase 1 non-hodgkin's lymphoma advanced malignancies
evaluation of a ascensia onyx next investigational blood glucose monitoring system

Conditions: Diabetes

Summary: the purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the investigational blood glucose monitoring system (bgms) and obtain valid glucose results.


Eligibility criteria:
inclusion criteria: * males and females, 18 years of age and older * able to speak, read, and understand english * willing to complete all study procedures exclusion criteria: * hemophilia or any other bleeding disorder * pregnancy * physical, visual or neurological impairments that would make the person unable to perform testing with the bgm * previously participated in a blood glucose monitoring study using the onyx next or onyx plus bgms * working for a medical laboratory, hospital, or other clinical setting that involves training on or clinical use of blood glucose monitors * working for a competitive medical device company, or having an immediate family member who works for such a company * a condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk general enrollment guidelines: * at least 70% of subjects will be younger than age 65 * at least 10% (approximately 10-15%) of subjects will be naive users * at least 20% of subjects with diabetes will have type 1 diabetes
protective effect of sivelestat against negative pulmonary function and organ dysfunction after cardiovascular surgery (panda vi)

Conditions: Aortic Dissection; Systemic Inflammatory Response Syndrome; Cardiovascular Diseases (CVD)

Summary: systemic inflammatory response syndrome (sirs) and multiple organ dysfunction syndrome (mods) are the major causes of death in patients with cardiovascular diseases. therefore, the prevention of sirs and mods is of great clinical value, and immunomodulatory therapy with sivelestat may be beneficial. this study was designed to test the hypothesis that the administration of sivelestat during the acute phase of cardiovascular diseases will result in a reduced incidence of sirs and mods.


Eligibility criteria:
inclusion criteria: * the patients are conformed to 2010 acc/aha guidelines for the diagnosis and treatment of thoracic aortic disease (tad) within two weeks of onset; * patients with type a acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled. * the patients' age between 18 \~90 years old. * agree to participate in the study and sign the informed consent. exclusion criteria: * patients allergic to sivelestat sodium; * lactating women and pregnant women; * patients with mental diseases, drug and alcohol dependence; * refuse to participate in this study and refuse to sign the informed consent.

Keywords: systemic inflammatory response syndrome
sils™ port laparoscopic cholecystectomy post market study

Conditions: Gallbladder Disease

Summary: the objectives of this trial are: 1. to assess the feasibility and safety of performing sils™ port laparoscopic cholecystectomy 2. monitor and compare the outcomes of sils™ port laparoscopic cholecystectomy versus 4plc to objectively document the scientific merit and the perceived advantages of sils™ port laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * between 18 and 85 years old. * patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or biliary dyskinesia with documented ef \< 30%. * body mass index (bmi) \< 45 kg/m2. exclusion criteria: * any female patient, who is pregnant, suspected pregnant, or nursing. * any patient with acute calculus or acalculous cholecystitis. * any patient who has had an upper midline or right sub costal incision. * any patient with pre-operative indication for a cholangiogram. * any patient with asa \> 3 with normal liver function. * any patient who is undergoing peritoneal dialysis (pd). * any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.

Keywords: laparoscopic cholecystectomy single incision laparoscopic surgery surgical procedures, minimally invasive
efit: an internet-based intervention to increase physical activity in persons with ms

Conditions: Multiple Sclerosis

Summary: efit is a technology-enabled internet based psychosocial intervention to increase physical activity in persons with multiple sclerosis, who are at unique risk for sedentary behaviors and for whom exercise and physical activity hold many benefits.

this is a randomized controlled trial of an internet-based intervention to increase physical activity in persons with multiple sclerosis. multiple sclerosis (ms) is the most common non-traumatic neurological cause of disability in young adults. sedentary behavior, now recognized as a major contributor to increased morbidity is seen at higher rates and related to adverse health outcomes for persons with ms (pwms). prominent symptoms of ms (motor impairment, fatigue, depressed mood, pain), place this population at unique risk for increased sedentary behavior. and importantly, with increased age comes increased risk: patients over 60 are significantly more sedentary than middle-aged patients. on a positive note, current disease modifying therapies prolong time to disease progression, widening the window of opportunity for implementing behavioral interventions that support health and successful aging. behaviors adopted early in life are more likely to be maintained into later adulthood. physical activity is beneficial for pwms on multiple levels: improved gait and balance, improved cognition, reduced depression and fatigue. finding ways to increase physical activity is a key research priority for ms. behavioral change is difficult to adopt and even more difficult to maintain. here, we introduce a novel behavioral intervention to increase physical activity, efit, a technology-enabled (i.e., internet-delivered) support group-based treatment that leverages accountability to motivate and sustain behavioral change. accountability constitutes the bedrock underlying the single most pervasive, successful, and widely embraced behavioral intervention known: alcoholics anonymous (aa). through sponsors and support groups, aa utilizes accountability partners to deliver, reinforce, and sustain life-saving behavioral change. here, we leverage accountability partners to motivate enduring behavioral change in physical activity participation, one of the single most difficult health behaviors to implement and maintain.

Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosis of multiple sclerosis exclusion criteria: * cannot be available for the next 12 weeks consecutively

Keywords: exercise physical activity