Kornimate/medical-research-clean huggingface dataset:
incidence of rhinological morbidities during endonasal pituitary surgery, with or without nasoseptal flap

Conditions: Surgery--Complications

Summary: determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap


Eligibility criteria:
inclusion criteria: * to be over 18 years old * to be operated on for pituitary surgery * to have express no objection to the study exclusion criteria: * refusal to participate in the study * pregnant women * to be under the age of 18 * not being able to understand and accept participation in the study * to have a life expectancy of less than a year
ablation or surgery for atrial fibrillation (af) treatment

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare 2 invasive strategies for atrial fibrillation treatment, endocardial catheter ablation isolation of the pulmonary veins versus minimally invasive thoracoscopic surgical epicardial isolation. both strategies are in use for several years now, and have been reported as a successful strategy with success rates of 60-90%. however, it is not known which technique is preferable in a given patient population in terms of efficacy to cure af, safety, or patient discomfort. therefore, in the present trial a randomized study is proposed to provide more insight into the relative merits of both techniques

atrial fibrillation is the most common cardiac arrhythmia, affecting millions of people around the world. it is a large burden on health care resources and may even lead to a shorter life expectancy. drug treatment has been found insufficient and sometimes even hazardous to the pt. traditionally, there was only one invasive approach available, being maze 3 procedure by means of full open chest cardiac surgery. this was a very invasive approach, limited to only a few skilled surgeons, with insufficient options to treat large pt volume. with the discovery that af often is initiated and maintained by electrical instability inside and around the pulmonary veins, catheter ablation is now a widely accepted early invasive strategy to cure af. success rates of 60% to 90% have been reported, depending on technique employed and the type of af (resp, chronic versus paroxysmal)

Eligibility criteria:
inclusion criteria: * patient has a history of symptomatic paroxysmal and/or persistent atrial fibrillation for at least 12 months * patient is refractory to or intolerant of at least one antiarrhythmic drug * patient has an enlarged atrium \>40 mm and/or patient has a failed previous catheter ablation and/or patient has additional risk factors such as hypertension, increasing age * patient is between 30 and 70 years of age * patient is mentally able and willing to give informed consent exclusion criteria: * cardiac ablation or surgical cardiac procedure in the last 3 months * previous cardiac tamponade * previous stroke or tia * left atrial thrombus * left atrial size \>65 mm * left ventricular ejection fraction \<45 % * active infection or sepsis * pregnancy * unstable angina * myocardial infarction (mi) within previous 3 months * atrial fibrillation is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause * history of blood clotting abnormalities * known sensitivity to heparin or warfarin * life expectancy is less than 12 months * patient is involved in another clinical study involving an investigational drug or device * pleural adhesions * prior thoracotomy * prior cardiac surgery * elevated hemi diaphragm

Keywords: atrial fibrillation
study of induction chemotherapy followed by radiochemotherapy in locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: there is no a clear consensus regarding the optimal treatment of locally advanced pancreatic disease. there is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. the investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer

continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer. in all patients an accurate pre-treatment staging was performed, including: physical examination, complete blood tests and tumor markers, endoscopic ultrasonography (eus) with fine needle aspiration biopsy, multilayer ct scan, pet-ct (positron emission computed tomography) with 18f-2-fluoro-2-deoxy-d-glucose (fdg) and laparoscopy with peritoneal washing. jaundiced patients before or during treatment underwent endoscopic biliary stenting. patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this neoadjuvant approach. the induction phase of the treatment plan was designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses. in the combined phase of the treatment all patients underwent simulation by using a siemens 16-ct simulator (siemens medical system). radiotherapy target volumes were established by ct scan and pet-ct scan. four weeks after the completion of radiochemotherapy, restaging, consisting of clinical examination, laboratory test, tumor markers, ct scan and pet-ct scan, was performed. tumor response was defined in accordance with the world health organization (who) definition through ct scan and pet-ct scan. surgery was considered in patients whose tumors were technically resectable. after resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years

Eligibility criteria:
inclusion criteria: * proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma; * borderline resectable or unresectable pancreatic tumours; * age between 18 and 75 years; * no previous radiochemotherapy to abdomen; * 0-i ecog (eastern cooperative oncology group) performance status; * adequate cardiac, liver and kidney function and a good bone marrow reserve. exclusion criteria: * resectable and metastatic disease; * previous or concomitant malignant disease; * one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, pa o2 \ 40 mmhg, mental disability.

Keywords: radiochemotherapy neoadjuvant therapy
cauterization versus ﬁbrin glue for conjunctival autografting in primary pterygium surgery

Conditions: Pterygium of Conjunctiva and Cornea

Summary: pterygium is a noncancerous growth of the conjunctival tissue over the cornea. it is a progressive disease that may lead to visual impairment in advanced stages, as well as restriction of ocular motility, chronic inflammation and cosmetic concerns. surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. in this randomized controlled cauterization will be compared with ﬁbrin glue for conjunctival autografting in primary pterygium surgery.


Eligibility criteria:
inclusion criteria: * adults (older than 18 years of age) * both sexes * primary nasal pterygia ˃4 mm, which tends to increase, including patients with reduced visual acuity, chronic inflammation, cosmetic reasons * if the patients had a bilateral pterygium, only one eye will be operated exclusion criteria: * connective tissue disease * prior eye surgery * chronic use of topical drugs (anti-glaucoma drugs)
telerehabilitation based motor imagery and action observation training in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life.

the study population was participants with relapsing remitting multiple sclerosis. the traditional rehabilitation program consists of a joint treatment in which lower extremity strengthening and balance exercises are carried out synchronously for the experimental and control groups. motor imagery and action observation therapy based on telerehabilitation of certain movements will be applied to the experimental group. all treatments will be carried out online via the zoom program. the treatment program will be applied 3 times a week for 6 weeks. evaluations will be made before and after the treatment program. assessments include balance, lower extremity muscle strength and functional mobility, fatigue, and quality of life.

Eligibility criteria:
inclusion criteria: * being diagnosed with mulltiple sclerosis according to the mcdonald criteria * expanded disability status scale\<5.5, * being between the ages of 18-65, * mini mental test score\>24, * have a phone that can adapt to participating in a video call exclusion criteria: * having another additional neurological disease that may cause balance and coordination disorders, * receiving physical therapy in the last 6 months, * having an attack in the last 3 months * refusal to participate in the study.

Keywords: motor imagery telerehabilitation action observation therapy
covid-intervention-study

Conditions: Psychosocial Intervention

Summary: the goal of this invention study is test and compare short-term manual-based psychosocial group interventions in die austrian population suffering from stresses and strains due to the covid-19 pandemic and other crises. the main question it aims to answer: does short-term manual-based psychosocial group interventions improve the mental well-being of the participants? participants will attend weekly a manual-based group (8 weeks) and answer online-questionnaires and surveys (pseudonymized).


Eligibility criteria:
inclusion criteria: * above 18 years with psychosocial stresses and strains due to covid-19 pandemic and other crises exclusion criteria: * suicidal tendency * insufficient knowledge of the german language * psychotic episode * no internet-access

Keywords: manual-based group intervention short-term intervention covid-19 crisis
a long-term study to describe the use of pascorbin® 7.5 g in patients with vitamin c deficiency

Conditions: Vitamin C Deficiency; Acute Disease; Chronic Disease

Summary: the aim of this long-term observational study is the documentation of the use of pascorbin® 7.5 g in patients with vitamin c deficiency. regarding the vitamin c deficiency, the investigators focus on the acquisition of data of the underlying diseases and the reduction of symptoms, that are related to oxidative stress and vitamin-c-deficiency. next to this, exact assessment of medical tolerance and details of treatment requirements are further aims. here the investigators take into account acute and chronic underlying medical conditions. further health economic data are collected.

the observational study began on 01 november 2012 and is scheduled for a period of 10 years continued (until 01 november 2022). the duration of the observational study for each patient is not fixed corresponding to the character of a non-interventional study. according to the underlying disease, characterized either acute or chronic, there are 2 and 3 observations within the treatment period, respectively. documentation comprises the course of the underlying diseases (by tracking of general and diseases-specific symptoms), drug compatibility (by adr assessment), concomitant medication or other treatment, health economic data, details of treatment regimen and standard epidemiological data.

Eligibility criteria:
inclusion criteria: * patients with vitamin c deficiency * patients \>= 12 years old exclusion criteria: * an oxalate urolithiasis, * iron storage disorders (thalassemia, hemochromatosis, sideroblastic anemia) or have received recently transfused packed red blood cells * under 12 years of age or * are pregnant or breastfeeding.
lymphedema specific pros for risk assessment, prevention and early detection

Conditions: Lymphedema

Summary: the purpose of this study is to find a way to detect a surgical complication, called lymphedema, at an earlier stage. this potential complication may develop in some patients after removal of the armpit lymph nodes (axillary dissection). it is very important to identify this condition as early as possible to improve the treatment options. this study will examine whether or not focused questionnaires are able to identify lymphedema, comparing to physical measurements (like arm circumference).


Eligibility criteria:
inclusion criteria: * patients 18 years old and older with biopsy-proven breast cancer. * scheduled for axillary dissection or probable axillary dissection or within 14 days after axillary dissection at either jackson memorial hospital (jmh) or university of miami (um). * patients that eventually did not undergo full axillary dissection but had 9 or more lymph nodes removed or received axillary radiation will be allowed to stay in the study. * intent to continue follow-up for at least 6 months post-operatively. * able to give an informed consent to participate in all study's stages. * willing and able to fill questionnaires in person or with assistance at baseline and at 6 months from surgery. * bilateral axillary dissection patients are eligible to be enrolled for each side. exclusion criteria: * previous axillary dissection. * lymph node biopsy except for biopsies related to the current cancer event. * congenital or acquired arm lymphedema. * nephrotic syndrome * anasarca * unable or unwilling to fill questionnaires at baseline and at 6 months from surgery.
testing the effect of the insupad device in daily life conditions

Conditions: Diabetics Mellitus Type 1; Diabetes Mellitus Type 2

Summary: this is the test protocol for the insupad device. the aim of the study is to show economical benefit when using the insupad device, by testing the effect of the insupad device on reducing injected insulin dose while keeping the same overall glycaemic control.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 to 75 years (including 18 and 75 years old). * type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of \> 60 iu/day. * hba1c \>=6.0% and =\< 8% * use of short-acting prandial insulin analogues with multiple daily injections. the analog insulin brands to be used will be either insulin lispro (humalog, liprolog) or insulin aspart (novorapid) or insulin glulisin (apidra). * subject agrees to sign consent form before any study-specific tests or procedures are to be performed. * study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book. exclusion criteria: * excessive fibrosis, lipo-hypertrophy or eczema at injection sites. * known gastro- or enteroparesis. * unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start. * severe hypoglycaemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start. * hypoglycaemia unawareness (score \> 4 in the hypoglycaemia awareness questionnaire) * diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start * any known life-threatening disease * pregnant women, lactating women or women who intend to become pregnant during the observation period * any other condition or compliance issues that might interfere with study participation or results * subjects with heat sensitivity * subjects involved in or planned to participate in other studies * subjects who are incapable of contracting or under guardianship

Keywords: dm insulin injections
casus: validation for detection of precursor lesions

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia; Human Papilloma Virus; HPV-Related Cervical Carcinoma; Urine

Summary: the goal of the overall casus project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. in contrast to current screening modalities, the casus approach will identify women with clinically relevant disease in need of treatment using only a single sample that can be collected at home (one-step triage).

casus work package 4 (wp4): the main aim of this study is to validate the hpv-risk assay (self-screen, the netherlands) followed by multiplex methylation specific quantitative pcr (qmsp, vu university medical center, the netherlands) on first-void urine (colli-pee small volumes (10 ml) device, novosanis, belgium) of hpv positive women for detection of clinically relevant precursor lesions by sampling a cohort of women referred for colposcopy. the number of women in this cohort will allow us to clinically validate the use of the hpv-risk/qmsp assay in dna extracts of first-void samples after optimization of sample volume, internal process control, and dna extraction method (centre for the evaluation of vaccination, university of antwerp, belgium).

Eligibility criteria:
inclusion criteria: * female * 25 years until 64 years old * referred to colposcopy due to a single/multiple (probable) high-risk hpv infection and/or abnormal cervical squamous intraepithelial/glandular lesion. * gives informed consent to the research team at the clinical study site to contact his/her general practitioner and/or gynaecologist to access details of the participants hpv test results and cervical screening history. * is able to understand the information brochure/what the study is about. exclusion criteria: * women that underwent hysterectomy * pregnant women * treatment for cervical cancer in the last 6 months before participation in the study * participating in an interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. participation in another observational or low-interventional clinical study at the same time is allowed.

Keywords: biomarker first-void urine screening triage
cognitive-based behavior change training program

Conditions: Behavioral Symptom; Preschool Child; Parent; Parent-Child Relations; Cognitive Ability, General

Summary: this study will be conducted to determine the effects of the parent education program based on the cognitive development of the child, which is applied to the parents of preschool children with behavioral problems, on the attitudes and stress levels of the parents and the problematic behaviors of the children. the purpose of this study has two dimensions; dimension 1: the 'parent education program based on the cognitive development of the child', which is planned to be developed for the purpose of measuring the attitudes, stress levels of the parents and the effects on the problematic behaviors of the children. the development of the program was based on jean piaget's theory of cognitive development. dimension: it is experimental. the aim is to reveal the effectiveness of the parent education program, which will be applied to the parents of children with behavioral problems. there are parent training programs developed for children with behavioral problems in the preschool period. however, the lack of parent studies based on the child's cognitive development reveals the rationale and importance of this study.


Eligibility criteria:
inclusion criteria: * children must be between the ages of 3-6 * participating in the study as a mother and father together * not having attended any parent training exclusion criteria: * participating in the study as a single parent * the child must have been diagnosed in the special needs category
exercise in patients with osteoarthritis of the hip

Conditions: Hip Osteoarthritis

Summary: according to danish and international guidelines the recommended first-line of management for people with osteoarthritis consist of exercise, education, analgesic medication, and, if necessary, weight reduction. it is well documented that exercise has a positive effect on pain and physical function in patients with knee oa, but the effect of exercise on hip oa is sparsely investigated. aim of the study: to investigate the effects of 1) strength training, and 2) nordic walking, and 3) unsupervised home based exercise on muscle function, endurance, pain level, physical activity, and health related quality of life in patients with osteoarthritis of the hip. the effects of exercise on muscle mass and the mechanisms behind the osteoarthritis, i.e., disease activity, inflammation, and cartilage degradation, are investigated in a subgroup (n=45) of the participants. study hypotheses: strength training will have a greater effect on physical function and muscle strength than nordic walking and home based exercise; 2) nordic walking will have a greater effect on endurance than strength training and unsupervised home based exercise; 3) strength training and nordic walking will have a greater effect on pain level and health related quality of life than unsupervised home based exercise.


Eligibility criteria:
inclusion criteria: 1)home-dwelling 60+ year old persons with primary, symptomatic hip oa who meet the clinical criteria of hip oa according to american college of rheumatology (acr), and who are not on a waiting list for hip joint replacement. exclusion criteria: 1. symptomatic oa in the knee or the big toe, 2. joint replacement of the knee or the hip, 3. other types of arthritis, e.g., rheumatoid arthritis, 4. previous hip fracture, 5. limitation in physical function to the extent that using public transportation is impossible, 6. co-morbidity that prevents exercising, 7. physiotherapy related to hip problems within the last 3 months, 8. steroid injections in the hip joint within the last 3 months, 9. performing exercise/sports 2+ times weekly, and 10. inability to cooperate.

Keywords: exercise hip osteoarthritis randomized controlled trial