Kornimate/medical-research-clean huggingface dataset:
lighthouse project on dementia, ulm, germany

Conditions: Dementia

Summary: the geriatric center ulm scientifically supported a three-year pilot study (projektdemenz ulm), in which numerous findings on the system of care regarding people suffering from dementia and their relatives were determined. one of the most important conclusions is the significant lack of information on the well-functioning network of the care system in ulm. the full potential of the network is not being exploited. the situation in the alb-donau-kreis - the area surrounding ulm - is very similar. the investigators' aim is to improve the utilization of the system of care for those suffering from dementia in ulm/alb-donau-kreis by using a newly designed advisory approach (lighthouse project on dementia, ulm, ultdem study). the purpose of the study is to prove the effectiveness of this procedure by using a prospective, open, randomized, controlled, interventional study. after the randomization, the interventional group is given comprehensive, individual advice about available treatment possibilities for people suffering from dementia. in addition, they have the opportunity to re-evaluate their present diagnostic procedure. the participants of the control group receive the standard treatment. inclusion criterion is the application of a care level ( level 0 or 1). recruitment will take one year. a final assessment will be taken every six months.


Eligibility criteria:
inclusion criteria: * dementia (mmse \< 24) * signing up for classification of care level (0 or 1) * community dwelling elderly (older than 60 years) * member of certain health insurance provider (aok, barmer, dak) * residents of ulm / alb-donau-kreis exclusion criteria: * result from the inclusion criteria * cancer * consuming disease

Keywords: dementia system of care level of care interventional study evaluation dementia diagnostic evaluation of the care study
combination tissue plasminogen activator (tpa) and dornase alfa (dnase) administration through intrapleural catheters for the treatment of loculated or non-draining malignant pleural effusions

Conditions: Loculated or Non-draining Malignant Pleural Effusions

Summary: the purpose of this study is to evaluate the efficacy and safety of intrapleural dornase alfa and tpa administered to patients with clinical failure of small-bore chest tube with persistent pleural effusions or malignancy-related loculated effusion to improve pleural drainage.


Eligibility criteria:
inclusion criteria: 1. clinical failure of small-bore chest tube with persistent pleural effusion 2. 18 years of age or older 3. eastern cooperative oncology group (ecog) performance status score 0-2. 4. life expectancy ≥ 6 weeks 5. absolute neutrophil count \> 1500 mm3, platelet count ≥ 100×109 l, hemoglobin ≥ 8.0 g/dl 6. serum creatinine ≤2.0 times the upper limit of the normal range, total bilirubin ≤ 2.5 mg/dl, ast/alt ≤ 5 times the upper limit of normal range 7. at least 2 days from administration of chemotherapy 8. at least 7 days from prior major surgery 9. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial. 10. patient judged to be 'medically stable' by primary investigator. exclusion criteria: 1. prior treatment with intrapleural fibrinolytic agents 2. presence of any intracranial mass 3. traumatic hemorrhagic pleural effusion 4. major hemorrhage, coincidental stroke, or major trauma 5. high-risk for systemic bleeding 6. allergy or intolerance to dornase alfa 7. active clinically serious infection \> ctcae (version 4.03) grade 2. 8. serious non-healing wound, ulcer, or bone fracture. 9. major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery. 10. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements. 11. concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements. 12. patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation in this study) 13. expected survival less than six weeks
the prospective leuven transcatheter valve therapy registry

Conditions: Heart Valve Diseases

Summary: assessment of feasibility, safety and outcomes of transcatheter valve interventions

transcatheter valve therapies have a growing impact on daily medical practice since the first human percutaneous implantation of an aortic valve bioprosthesis by a. cribier in 2002. while initially these techniques were reserved for patients at prohibitive risk for surgical aortic valve implantation, indications moving toward patients at high and intermediate risk. outcomes of these percutaneous interventions need to be monitored to assess quality of care and tailor indications in this rapidly moving field in interventional cardiology. trial objectives and design trial objectives * to describe patient populations selected for transcatheter valve treatment * to describe procedural aspects and results * to perform clinical and hemodynamic follow-up of the patients primary endpoints the primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the valve academic research consortium criteria (2-3). secondary endpoints the secondary endpoints of the study are hemodynamic outcomes after transcatheter valve interventions according to the valve academic research consortium criteria (2-3). quality of life parameters, as well as exercise tolerance will be assessed. trial design the design of the trial is a prospective non-interventional registry.

Eligibility criteria:
inclusion criteria: * all patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry exclusion criteria: * all patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. there are no formal exclusion criteria.
blood and tissue extraction for immunological examinations during neoadjuvant therapy of soft tissue sarcomas

Conditions: Soft Tissue Sarcoma Adult

Summary: "blood and tissue extraction for immunological examinations during neoadjuvant therapy of soft tissue sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging.

all patients (\> 18 years) with histologically confirmed high-risk soft tissue sarcoma eligible for neoadjuvant multimodal therapy (including radiotherapy +/- concomitant and sequential chemotherapy +/- hyperthermia as well as surgery) are screened for the study. neoadjuvant therapy consists of 50-50.4 gy in 25-28 fractions. additional concomitant or sequential chemotherapy may be applied in selected cases (young patients, high-grade tumors). additional hyperthermia concomitant to neoadjuvant radiotherapy is applied in selected cases if not contraindicated. preoperative tissue sampling to generate primary tumor cell lines in additional translational research is performed in each patient with a lesion suspect for soft tissue sarcoma and eligible for multimodal therapy. primary cell lines are analyzed biologically (growth pattern, radioresistance, migration, molecular markers rt-pcr, immunological properties such as immunogenic cell death, lysis by cellular immunotherapies such as car-nk cells. postoperative tumor tissues are additionally analyzed for immune cell mapping using complex immunohistochemistry. biopsy and resection should include proteome analysis and dna sequencing (only of the tumor tissue, not normal tissue). additional immunological monitoring (including cellular immune status, serum marker e.g. cell free dna, hmgb1) is performed using blood sampling with in total 4 blood controls (25 ml each, before neoadjuvant radiotherapy, during the second and last week of radiotherapy as well as before surgery). in patients treated with concomitant mr-guided hyperthermia, weekly mr-imagine is performed. follow-up is carried out as part of the oncological controls over 5 years. the overall study is planned over a period of 5 years (interventional part), additional 5 years follow-up period.

Eligibility criteria:
inclusion criteria: * planned histological confirmation for especially high-risk soft tissue sarcoma via open sampling * indication for neoadjuvant multimodal therapy (radiation and locoregional hyperthermia, optionally with simultaneous chemotherapy) * planned resection of a department of the cws * age \> 18 years * ability to consent * additionally for imaging study: treatment on the combined mr hyperthermia device exclusion criteria: * age \< 18 years * poor understanding (language etc.) * lack of reconnaissance ability

Keywords: soft tissue sarcomas immunological examinations neoadjuvant therapy radiotherapy
margetuximab expanded access program

Conditions: HER2-positive Breast Cancer; HER2-positive Carcinoma

Summary: the purpose of the expanded access program is to provide margetuximab to patients with pretreated her2+ breast cancer for whom potential benefit justifies potential treatment risks.

tersera therapeutics llc (tersera) will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to margetuximab and for tersera to supply margetuximab for single patient use.

Eligibility criteria:
inclusion criteria: * tersera may consider requests on a case-by-case basis from treating physicians for patients not otherwise eligible for margetuximab clinical studies. * treating physicians should consider approved therapies for a patient's disease, as well as ongoing clinical studies, before seeking expanded access use with an investigational agent. exclusion criteria:
artificial intelligence assisted breast ultrasound in breast cancer screening

Conditions: Breast Cancer; Screening

Summary: aibu is a randomized, open-label study assessing the effectiveness of an articificial intelligence-assisted breast ultrasound breast cancer screening strategy compared to standard screening (according to the current local guidelines in each participating area) in detecting late-stage breast cancers.

we enrolled asymptomatic women women from january 2021 to december 2022, and then followed up for the next 1 year. the main study endpoint will be measured at the end of the one year after intervention.

Eligibility criteria:
inclusion criteria: * women aged 35-70 who participated in breast cancer screening (shanghai rural women "women two cancer screening project", national major public health service project "rural women breast cancer screening project" and "gynecological diseases and breast diseases screening project for retired and living difficult women") in shanghai district exclusion criteria: * 1. personal history of breast carcinoma, either invasive or ductal carcinoma in situ (dcis); 2. personal history of any types of malignant neoplasms; 3. known condition or suspicion of severe cardiopulmonary insufficiency, liver and kidney insufficiency and other systemic diseases; 4. known condition or suspicion of serious comorbidities and average life expectancy less than 5 years; 5. history of lateral or bilateral mastectomy; 6. disagree to participate in the study and follow-up interviews.

Keywords: cancer epidemiology artificial intelligence ultrasound
assessment of heterotopic ossification of elbow joint in relation of serum uric acid.

Conditions: Heterotopic Ossification

Summary: heterotopic ossification (ho) is a common complication after surgical repair of elbow trauma. uric acid is the end-product of purine metabolism that has any physiological and pathogenic potential functions. however, the relationship of ho and uric acid has not been explored up to now. this study aimed to assess the relationship of ho and uric acid. the investigators retrospectively reviewed the demographics of participants who undergone the surgery for elbow trauma in our hospital between january 2012 and december 2018. one hundred participants included in our study. the participants were divided into two groups by the existing ho or not. the serum uric acid between both groups were compared by using the independent samples student t tests.

the investigators retrospectively analyzed the demographics of these participants in our hospital who underwent the surgery after trauma of elbow joint between january 2012 and december 2018. all of the participants had a previous history of elbow joint fractures including distal humerus fracture or proximal ulna fracture or capitulum radii fracture or elbow fracture dislocation. according to x ray or ct scan, the participants were divided into two groups. one group the participants had not existed radiographic evidence of heterotopic ossification or formatted ectopic lamellar bone. and the other group is the participants with radiographic evidence of heterotopic ossification. and we recorded patient serum uric acid, sex and age, body mass index (bmi), the situation of joint trauma and comorbid conditions including diabetes mellitus or impaired blood glucose, gout, metabolic syndrome, osteoporosis and various vitamin deficiency diseases. moreover, the grades of heterotopic ossification were recorded for all patients according to hastings and graham classification system for heterotopic ossification at the elbow joint.

Eligibility criteria:
inclusion criteria: * have a previous history of elbow joint fracture or dislocation that conform to its manifestations and signs. and it is diagnosed by x-ray test. ho must accord with the relative diagnostic criteria5 and have imaging evidences of heterotopic ossification. * have complete clinical and imaging dates. * the age\>18 and no gender limitation. * the patient is being a relatively stable physical and mental state without acute injection or diseases. exclusion criteria: * have a history of diabetes mellitus or impaired blood glucose, metabolic syndrome and gout or renal dysfunction (creatinine ≥ 1.5 mg/dl) that apparently influence glucose, lipid and protein metabolic of the body. * have a history of taking drugs that can influence uric acid metabolic including gout suppressant, diuretic, small-dose aspirin (75\~300mg/d) or large-dose aspirin (\>3g/d), anti-tuberculosis drugs, immunosuppressor, nicotinic acid and anti-tumor drugs such as cyclophosphamide and so on.

Keywords: heterotopic ossification serum uric acid， elbow joint
rheological functions of erythrocyte in esrd

Conditions: End-stage Renal Disease (ESRD)

Summary: end-stage renal disease (esrd) disrupts erythrocyte deformability due to osmotic imbalances, oxidative stress, and uremic toxins, leading to impaired microcirculation and oxygen transport. dysregulation of ion channels, particularly the gardos channel, exacerbates dehydration and eryptosis, further compromising vascular integrity. given the critical role of erythrocyte flexibility in oxygen delivery, this study investigates its relationship with aerobic capacity in esrd patients, highlighting potential mechanisms of microvascular dysfunction

end-stage renal disease (esrd) profoundly alters osmotic homeostasis, disrupting erythrocyte deformability and impairing microcirculatory dynamics, ultimately compromising oxygen delivery to tissues. persistent oxidative stress, hyperosmotic fluctuations, and accumulation of uremic toxins collectively modulate ion channel activity, particularly by stimulating cation influx and perturbing calcium regulation. these disruptions accelerate erythrocyte aging and promote eryptosis, a programmed form of red blood cell death. furthermore, dysregulation of the gardos channel exacerbates potassium efflux, leading to excessive cell dehydration, increased blood viscosity, and further deterioration of vascular integrity. given the pivotal role of erythrocyte flexibility in oxygen transport efficiency, impairments in osmotic deformability may contribute to the reduced aerobic capacity frequently observed in esrd patients. this study aims to elucidate the interplay between erythrocyte biomechanical properties and cardiopulmonary fitness in this population, shedding light on potential therapeutic targets to mitigate microvascular dysfunction.

Eligibility criteria:
inclusion criteria: * receiving hemodialysis and medication at least for 6 weeks * kt/v score \> 1.2 exclusion criteria: * under 20 years-old * hyperkalemia occurs within 3 month * having orthopedic or muscular diseases * other concerned medical, psychological or physiological diseases * pregnancy * other exercise contraindications

Keywords: hemodialysis aerobic capacity deformability erythrocyte
combination vaccination before hiv treatment interruption

Conditions: HIV Infections

Summary: the purpose of this study is to determine if vaccination before a structured treatment interruption (sti) is associated with an improvement in immune function, resulting in a delayed and reduced rebound in the amount of hiv virus in the blood.

volunteers will be randomly assigned to receive the vaccines or matching placebos before interrupting their antiretroviral therapy at week 24. dosage: remune(tm) 1 ml i.m.\* at weeks 0, 12, and 20; alvac 1 ml i.m.\* at weeks 8,12, 16, and 20. \* i.m.: injected in a muscle

Eligibility criteria:
inclusion criteria: * documented hiv infection (by serology) * hiv rna level below 50 copies/ml for at least two years * receiving at least 2 antiretroviral agents including at least 1 protease inhibitor or 1 non-nucleoside reverse transcriptase inhibitor at time of screening * have cd4 counts above 500 cells/ul * have cd4/cd8 ratio above 0.5 * have never had a cd4 count below 250 * no previous aids-defining opportunistic infection * no previous cancer chemotherapy or other system immunosuppressive therapy (excluding brief courses \[\<= 1 month\] of prednisone or its equivalent) * able to provide informed consent exclusion criteria: * hepatitis b surface antigen positive * hepatitis c antibody positive * ast, alt, alp, creatinine, urea above three times the normal upper limit * blood abnormalities (hemoglobin lower than 100, white blood cell count \[wbc\] lower than 1500 or platelets lower than 100) * allergies to components of remune™ or alvac * contraindications to vaccine components * pregnancy or breastfeeding

Keywords: hiv vaccination
physical co-morbidity, poor health behaviour and health promotion in verona patients with functional psychoses

Conditions: Psychotic Disorders; Bipolar Disorders

Summary: the study evaluates the efficacy of health promotion strategies on diet and physical activity in patients with psychosis. half of the participants will receive an intervention protocol based on education and behavioural change, while half will not receive it.

epidemiological studies investigating the mortality and physical health of mental patients have provided substantial evidence of an excess mortality and of a substantially higher prevalence of physical co-morbidity as compared to the general population. these findings have been related to a higher prevalence of risk factors like high blood pressure, high plasma cholesterol and obesity, unhealthy lifestyles, medication side-effects. the number of clinical trials and intervention studies in this area is still scanty and their scientific strength is relatively modest. the present research project aims at implementing preventive strategies related to dietary habits and physical exercise, and studying their efficacy with a randomized controlled study.

Eligibility criteria:
inclusion criteria: * icd-10 diagnosis of affective or non-affective functional psychosis (codes f20-22, f24, f25, f28-f31, f23.3, f33.3) * one or more contacts with the cmhs in the 3 months preceding the beginning of the recruitment * age 18-65 exclusion criteria: * moderate or severe mental handicap (learning disability) * organic brain disorders * lack of capacity to consent to inclusion * subjects already involved in individual treatment related to diet and physical exercise * subjects deemed unable or unfit to participate in the proposed physical activities

Keywords: health promotion lifestyles physical comorbidity risk factors behavioural change
effect of lifestyle changes on erectile dysfunction in obese men: a randomized controlled trial

Conditions: Erectile Dysfunction

Summary: healthy lifestyle factors are associated with maintenance of erectile function in men. to determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men. randomized, single-blind trial of 110 obese men without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the international index of erectile function (iief). the 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. men in the control group (n = 55) were given general information about healthy food choices and exercise.


Eligibility criteria:
inclusion criteria: * obese, sedentary (\<1 hour per week of physical activity) men with erectile dysfunction (a iief score lower than 22)and no evidence of participation in diet reduction programs within the last 6 months exclusion criteria: * diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dl \[7.8-11.1 mmol/l\] 2 hours after a 75-g oral glucose load) * impaired renal function, including macroalbuminuria, pelvic trauma, prostatic disease, peripheral or autonomic neuropathy * hypertension (blood pressure \>140/90 mm hg) * cardiovascular disease * psychiatric problems * use of drugs or alcohol abuse (500 g of alcohol per week in the last year).

Keywords: obesity lifestyle changes
inflammation, immune activation and portal hypertension in alcoholic hepatitis

Conditions: Alcoholic Hepatitis

Summary: the purpose of this study is to investigate the role of endotoxins and the endotoxin mediated immune activation pathway in patients with alcoholic hepatitis. also, to determine the effect of liver assist (liver dialyses) intervention on these parameters in patients with severe alcoholic hepatitis.


Eligibility criteria:
inclusion criteria: patients with alcoholic hepatitis based on the following criteria * alcohol intake for 6 consecutive months above 40g /day, at admission or 3 months earlier. * serum bilirubin level above 80 mmol/l * exclusion of other types of liver disease. * liver biopsy when diagnosis is unclear. exclusion criteria: * heart failure * pregnancy * non fluent danish speakers

Keywords: alcoholic hepatitis alcohol endotoxin lps liver dialysis innate immunity toll like receptors