Kornimate/medical-research-clean huggingface dataset:
legtest multi centre testing of the lively legs program for promoting compliance in leg ulcer patients

Conditions: Leg Ulcers; Varicose Ulcers

Summary: leg ulcers are often chronic or recurring complications of peripheral circulation disorders. patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. especially exercise and compliance with compression therapy are key elements in the course of leg ulcer healing and recurrence. yet many patients demonstrate sedentary lifestyles and non-compliance and current practice offers no systematic approach in the promotion of compliance and physical activity in these patients. the purpose of the study is testing 'lively legs' a compliance promotion program for patients with leg ulcers. the study tests the program on effects regarding: * compliance with compression therapy and exercise levels * time to leg ulcer recurrence * cost effectiveness from a social perspective.

the project is a multi centre study, using a randomized controlled design. patients in the study (n=380) are equally randomized to either the experimental or the control group. patients in the intervention group receive counseling during a period of six months, in line with the lively legs program. patients in the control group receive regular care. recruitment takes place within a period of nine months. data are collected at baseline, directly after the intervention period at 6 months, and at follow-ups at 12 and 18 months. quality of life is additionally assessed at 3, 9 and 15 months. the population for this study consists of leg ulcer patients, suffering from peripheral circulation disorders of venous or mixed (venous and arterial) origin. the population is restricted to patients treated at outpatient clinics for dermatology. individual counseling is performed by nurses, based on the lively legs lifestyle-program for leg ulcer patients. this evidence-based program was systematically developed using the intervention mapping framework, thus integrating scientific evidence, relevant theories and patient and care provider expertise. the program aims at improved compliance with compression therapy and prescribed exercise level in all patients. social cognitive theory provides the theoretical framework and the core methods for the lively legs program. nurses will perform the central role as health counselor. in a maximum of six consultations, they will offer tailored counseling, including compliance and physical activity assessment, identification of relevant determinants of behavior, goal setting, and the application of methods and strategies from the lively legs program

Eligibility criteria:
inclusion criteria: * venous insufficiency * venous and arterial insufficiency * receiving treatment on outpatient clinics for dermatology at the moment of inclusion or in the past three months before inclusion exclusion criteria: * total immobility * insufficient mental capacity * insufficient comprehension of the dutch language

Keywords: randomized controlled trial health-counseling multi-center study
phase ii trial of concurrent administration of intravesical bcg & interferon in the treatment and prevention of recurrence of superficial transitional carcinoma of the urinary bladder

Conditions: Transitional Carcinoma of Urinary Bladder

Summary: phase ii trial of concurrent administration of intravesical bcg \& interferon in the treatment and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.


Eligibility criteria:
inclusion criteria: * patients with superficial transitional carcinoma of the urinary bladder
study to evaluate an influenza vaccine candidate

Conditions: Influenza

Summary: the purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to fluarix™ administered intramuscularly in elderly aged 60 years old and above.

subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. the immune response will be evaluated at days 0, 21 and 180 after vaccination. the safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.

Eligibility criteria:
inclusion criteria: * a male or female age 60 years or older at the time of the vaccination. * subjects who the investigator believes can and will comply with the requirements of the protocol * written informed consent obtained from the subject. * free of an acute aggravation of the health status as established by clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination. * history of hypersensivity to a previous dose of influenza vaccine. * previous vaccination against influenza within the 9 months prior to enrollment. * history of confirmed influenza infection within the last 12 months. * history of allergy or reactions likely to be exacerbated by any component of the vaccine(s) * acute disease at the time of enrolment.

Keywords: influenza influenza vaccine
medication development in alcoholism: investigating ppar agonists

Conditions: Alcoholism

Summary: the primary hypotheses under test are that alcohol dependent subjects treated with fenofibrate will report decreased craving for alcohol following cue-exposure in the laboratory and report less drinking post treatment relative to placebo.


Eligibility criteria:
inclusion criteria: * male or female volunteers, 18-65 years of age * meets dsm-v criteria for alcohol use disorder ≥ moderate severity and dsm-iv criteria for current alcohol dependence * subjects will not be seeking treatment because the medication studies are not treatment trials * subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session * negative bac and a ciwa score of \< 9 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures * in acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ecg, urine test and lab tests * females with childbearing potential must have a negative serum pregnancy test on the screening visit with a negative urine pregnancy test at randomization and agree to use an effective method of birth control for the study duration and two weeks thereafter. * subjects must be able to complete and understand questionnaires and study procedures in english and sign an informed consent * willingness to comply with the provisions of the protocol and take daily oral medication exclusion criteria: * subjects with a medical condition that contraindicates the administration of fenofibrate or that will increase potential risk as determined by the study physician. * ggt more than 3 times the upper limit of normal * female subjects with childbearing potential who are pregnant, nursing, or refuse to use an effective method of birth control for the duration of the study and two weeks thereafter * meets dsm-v criteria for a major axis i disorder including mood or anxiety disorders or substance use disorders (e.g., cocaine, amphetamines, heroin, pcp) other than alcohol or nicotine * has a positive uds at screening or visit 3 (laboratory session) * treatment within the month prior to screening with an investigational drug, vaccine or drugs that may influence study outcomes, or drugs that may pose a safety risk as determined by the study physician. * history of hypersensitivity to the study drugs or the ingredients

Keywords: alcohol relapse
hyperinsulinemic normoglycemic clamp for pancreas and simultaneous pancreas/kidney transplant recipients

Conditions: Postoperative Complications

Summary: this study proposes a simple and safe way of lowering this complicate rate, while improving graft recovering and protecting the graft as it recovers from the transplant. the investigators hypothesize that by maintaining a tight glucose control via a glucose-insulin clamp during surgery and 72 hours post-operatively the investigators will be able to lower the complication rate by 50%.


Eligibility criteria:
inclusion criteria: * male or female patient over 18 years of age * patient is about to receive a pancreas or a simultaneous pancreas/kidney transplant * able to give written informed consent prior to any study specific procedure exclusion criteria: * multi-organ transplant other than kidney transplant * no central venous access available to deliver the d20w solution

Keywords: pancreas transplantation kidney transplantation organ transplantation pancreas and simultaneous pancreas/kidney transplant recipients
neurotherapy to promote emotion recognition in autism

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a neurodevelopmental disorder, more prevalent than previously thought and heterogeneous in expression, though uniformly characterized by severe social disability. the social disability that defines asd pervades other areas of adaptive behavior, is predictive of secondary mental health problems, and adversely affects long-term outcome. although asd is a chronic condition, there has been little research on interventions for adults with asd. this study proposes to first establish the neural plasticity of specific brain mechanisms underlying difficulties with facial emotion recognition, a core deficit believed to be pivotal in the behavioral expression of asd-social disability. the investigators will then develop a novel, computer-based intervention using real-time feedback, to the user, to ameliorate emotion recognition deficits.

individuals with autism spectrum disorder (asd) are known to have difficulty in the recognition of facial emotion. such deficits in facial emotion recognition (fer) are thought to cause or exacerbate social disability in asd by preventing 1) accurate detection of social/emotional information conveyed through the face and, subsequently 2) the deployment of emotionally appropriate responses. consistent with this model, fer deficits are correlated with social disability in asd and confer morbidity above and beyond core symptoms. the long-term goal is to understand how fer networks can be manipulated for therapeutic and preventative purposes. in this trial, investigators are testing the feasibility of an intervention that capitalizes on our previously developed brain-computer interface (bci) to promote fer in a mixed virtual reality world. the new "fer assistant" tool (deployed on a tablet - ipad) is intended to aid users in detecting emotions and intents of 'avatars' inhabiting a virtual world, and will provide users with a highly realistic testbed for practicing fer skills in concert with bci.

Eligibility criteria:
inclusion criteria: * diagnosis of asd exclusion criteria: * no severe psychopathology which warrants other immediate treatment
chatbot intervention to reduce common digital addictions, sedentary behaviors and mental distress among adolescents

Conditions: Internet Gaming Disorder; Social Media Addiction

Summary: the goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (soc) and motivational interviewing (mi)-based chatbot-assisted intervention in reducing digital addictions in adolescents with internet gaming disorder (igd) and/or social media addiction (sma) by conducting a rct. hypothesis: the intervention group will show a greater reduction in rates of igd and/or sma at post-treatment and 3-month follow-up than the control group. design and subjects: a two-armed rct between the intervention group and psycho-educational control group for adolescents aged 10-19 with excessive screen time. screening, baseline, post-programme, and 3-month follow-up evaluations will be conducted. participants will: be randomly assigned to online brief intervention or psycho-educational control complete questionnaires evaluating 1 ) primary outcomes (igd, sma), 2) secondary outcomes (sedentary lifestyle, mental distress, quality of life, ehealth literacy) and 3) mediators/mechanisms (autonomy, competence)


Eligibility criteria:
inclusion criteria: * students at grades 5-6 in primary schools or grades 7-12 in secondary schools, * positive screening results of igd and/or sma) based on the validated screening tools * using smartphone or internet on a daily base, 4) students' and parental consent, * chinese speaking. exclusion criteria: * current use of any psychotropic medication.

Keywords: internet gaming disorder chatbot social media addiction stage of change motivation enhancement low-intensity sedentary lifestyle adolescent mental health
efficacy of igiv in patients with igg subclass deficiency and recurrent infections

Conditions: IgG Deficiency; Infections

Summary: * this is the first study, that we are aware of, that will evaluate the efficacy of igiv in patients with igg subclass deficiency. * will provide data for further collaboration in extending study to involve other immunological centers in the united states to study patients with similar disease.

\*10 consenting adults (18 or older) will receive igiv (gamunex 10%) monthly at a dose of 400mg/kg body weight iv at 3ml/minute. comprehensive labs will be monitored at each visit, as well as clinical eval, plus patients will complete a questionnaire each time. there is also a 3 month follow-up visit after completion of therapy. specific xrays will be done at the beginning and with the last treatment.

Eligibility criteria:
inclusion criteria: * adult (18 or older) with deficiency in one or more igg subclasses with documented history of recurrent infections limited to upper or lower respiratory tract, urinary, and/or skin. exclusion criteria: * patients with panhypogammaglobulinemia or selective iga deficiency.

Keywords: immunodeficiency gammaglobulin igg subclass deficiency with recurrent infections
the effect of therapy with bevacizumab in chronic central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: the pathophysiology of central serous chorioretinopathy remains controversial. traditional treatment is laser photocoagulation or photodynamic therapy.recently bevacizumab (avastin, genetech),an antibody to vascular endothelial growth factor (vegf),has known antipermeability properties and therefore may theoretically reverse the changes seen in central serous chorioretinopathy. the aim of this study is to investigate concentrations of growth factors and inflammatory cytokines and to report the effect of therapy with bevacizumab in eyes with central serous chorioretinopathy


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of central serous chorioretinopathy * idiopathic neurosensory retinal elevation demonstrated by optical coherent tomography * presence of focal leaks at the level of the rpe on fluorescein angiography exclusion criteria: * known side effects of systemic bevacizumab administration * have a significant cardiovascular or thromboembolic history or were pregnant
spanish survey on third wave of covid-19

Conditions: Covid19

Summary: due to the pandemic situation, a rapid online survey may be the best method to assess and track people's pandemic cooping. regarding the huge media influence and the government's restrictions to control the spread of covid-19; it is needed to know more about people's perception and situation to conduct future contentions plans. this study aims to apply a rapid online survey to determine the spanish situation in this third wave of the pandemic. the survey will be delivered to 1000 participants to obtain a representative sample. it would be divided into six sections (general information, demography data, social and consuming habits, covi-19 question, questions for covid-19 positive, and questions for covid-19 negative).


Eligibility criteria:
inclusion criteria: * owning online connection * ability to answer and complete the survey exclusion criteria: * none

Keywords: covid-19 epidemiology signs and symptoms spain rapid online survey
positron emission tomography imaging using copper cu 64 tp3805 in patients with breast cancer

Conditions: Breast Carcinoma

Summary: this clinical trial studies positron emission tomography imaging in using copper cu 64 tp3805in patients with breast cancer. diagnostic procedures, such as positron emission tomography (pet) and positron emission mammography (pem) scan, using cu-64-tp3805 may help doctors find and diagnose breast cancer.

objectives: i. the study's primary goal is to assess the ability of cu-64-tp3805 (copper cu 64 tp3805) to detect primary breast lesions as determined by the f-18-fdg (fludeoxyglucose f 18) scan. ii. the study's second goal is to determine the ability of cu-64-tp3805 to detect primary breast lesions as determined by histology (sensitivity). iii. the study's third goal is to determine the ability of cu-64-tp3805 to detect metastatic lesions as identified by the f-18-fdg whole-body scan. outline: this is a dose-finding 2-stage study. stage i: patients with a positive biopsy and abnormal (positive) fludeoxyglucose f18-labeled pet whole-body scan undergo a whole-body copper cu 64 tp3805-labeled pet scan. stage ii: patients with a positive biopsy, but no fludeoxyglucose f18 scan undergo a breast fludeoxyglucose f18-labeled pem scan followed by a breast copper cu 64 tp3805-labeled pem scan.

Eligibility criteria:
inclusion criteria: * female * breast cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive f-18-fdg whole-body scan) * tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (mri) * signed informed consent form approved by the institutional review board (irb) exclusion criteria: * pregnant or lactating female * patient with asthma
mostafa maged four-stitch technique in closure the episiotomy during vaginal delivery

Conditions: Vaginal Delivery; Suture, Complication; Tear; Cervix; Hematoma; Ecchymosis

Summary: most primigravida is confronted with episiotomy during childbirth to prevent the perineal and vaginal lacerations which could be performed at birth. there are many types of episiotomy which are median, mediolateral, and j-shaped episiotomy. prevention of the formation of the dead space during the repair of episiotomy so avoiding hematoma formation in the episiotomy area after child-birth. the mostafa maged four-stitch technique uses absorbable vicryl threads with round needles 75 mm.

methodology: this technique will be applied to all women with episiotomy at the time of delivery or having tears in the perineum or the vagina. the technique uses absorbable vicryl threads with round needles 75 mm long. the technique includes the vaginal epithelium and the deep muscle layer together continuously at the same sutures. assessment of the perineal area in the next twenty-four hours till discharge looking for (edema - hematoma - septic wound - continence - ecchymosis - dyspareunia).

Eligibility criteria:
inclusion criteria: 1. primigravida patients having episiotomies or tears in the vagina 2. age between 18 to 40 years old exclusion criteria: 1. smokers 2. diabetics 3. morbidly obese patients 4. chronic diseases such as renal diseases

Keywords: primigravida, episiotomy, childbirth, mostafa maged ecchymosis
acute cerebrovascular events in patients undergoing catheter ablation

Conditions: Arrhythmia; Acute Cerebrovascular Disease

Summary: this study aims to evaluate the incidence, clinical characteristics, and short-term prognosis of acute cerebrovascular events occurring in-hospital in patients with arrhythmias following catheter ablation. the goal is to provide evidence supporting the improvement of patient quality of life and reduction of in-hospital acute cerebrovascular complications in patients with post-ablation arrhythmias. this will also contribute to the evidence-based clinical management of such patients.

with the steady development of catheter ablation, it has gradually become the main treatment of various arrhythmias. antithrombotic and anticoagulant therapy after catheter ablation determines the occurrence of perioperative bleeding and ischemic events. however, the incidence, characteristics and short-term prognosis of secondary acute cerebrovascular events in patients with arrhythmia after catheter ablation have not been studied. methods: this study was intended to retrospectively collect and analyze the case data and auxiliary examination results of patients with arrhythmia who underwent catheter ablation. to evaluate the incidence, clinical features and short-term prognosis of secondary acute ischemic and hemorrhagic cerebrovascular events in patients with arrhythmia after catheter ablation. in order to improve the quality of life of patients, reduce the secondary acute cerebrovascular complications in the hospital in patients with arrhythmia after catheter ablation, to provide evidence for promoting the clinical management of such patients, and to provide help for the maximum degree of prevention and control risk.

Eligibility criteria:
inclusion criteria: * 1.patients who undergo catheter ablation for arrhythmias. exclusion criteria: * 1. patients were diagnosed of acute cerebrovascular disease prior to radiofrequency catheter ablation; * 2. patients \ 80 years; * 3. patients with uncomplete clinical data.

Keywords: catheter ablation arrhythmia major adverse cardiovascular and cerebrovascular events (macce)
validation of low dose ct for diagnosis of lung nodules

Conditions: Cancer; Metastasis to Lung

Summary: the investigators have developed an extremely low dose computed tomography (ct) protocol that on preliminary testing has an effective dose in the range of two chest radiographs. the investigators plan to test this exam in patients with known or suspected cancer undergoing clinically indicated chest ct.


Eligibility criteria:
inclusion criteria: * pediatric and young adult patients (ages 4 to \<21 years) * known or suspected malignancy other than lymphoma * undergoing clinically indicated ct of the chest exclusion criteria: * pregnancy identified by routine department of radiology verbal screening * prior enrollment in the same study (no patient will be enrolled more than once) * inability to provide consent and/or assent * lymphoma