Kornimate/medical-research-clean huggingface dataset:
par i - patient-to-annulus relation i

Conditions: Aortic Valve Disease

Summary: the prosthesis-to-annulus relation i (par i) trial is a german multicenter study assessing the relation between the prosthetic goa and the area of lvot as potentially new parameter for the prediction of hemodynamic outcome. the results may possibly guide future valve size selection an may allow prediction of functionally relevant ppm (patient-prosthesis-mismatch)

great debates revolve around the hemodynamic performance of prosthetic tissue valves. it is influenced by the design and the specific sizing strategy. design determines the actual geometric orifice area (goa), sizing strategy the actual size of the selected valve. currently, hemodynamic performance is generally assessed by determining the effective orifice area (eoa, derived from the continuity equation by relating flow velocities and lvot area). the question whether a prosthesis patient mismatch (ppm) is present is then addressed by relating eoa to body surface area (eoai). however, this relation may not be reasonable because eoai relates flow velocity twice to patient-specific anatomic parameters (lvot area and body surface area) . considering this potential methodological flaw, debate and confusion regarding ppm is easily understood, despite the fact that, intuitively leaving a gradient behind after aortic valve replacement cannot be irrelevant. thus a reliable and comparable method to determine the presence of ppm is needed. in par i trial the relation between true prothetic goa and lvot area will be assesses as a potentially new parameter for prediction of hemodynamic outcome, to possibly guide future valve size selection (inclusive valve-in-valve) and to allow the detection of functionally relevant ppm. in the trial it will be assessed how anatomic dimensions of patients and implanted valves relate to each other and whether they allow the prediction of hemodynamic outcome.

Eligibility criteria:
inclusion criteria:1.patient has an indication for primary, isolated aortic valve implantation 2. patient is above 18 years old 3. patient has signed patient informed consent 4. foreseen implantation of an epic, epic supra or trifecta valve 5. patient has sinus rhythm exclusion criteria: 1. patient is younger than 18 years 2. patient has active endocarditis 3. patient is not able or does not want to participate on follow-up 4. patient is pregnant or nursing 5. surgical widening of outflow tract is planned 6. left ventricular ejection fraction is smaller than 50% 7. patient has a mitral valve or tricuspid valve insufficiency or stenosis bigger or equal grade ii

Keywords: aortic valve disease, patient prosthesis mismatch
cryoablation for the promotion of local tumor infiltration in patients with mesothelioma

Conditions: Mesothelioma

Summary: this trial evaluates if cryoablation will stimulate a local immune response by cluster of differentiation 8 positive (cd8+) cells which are not present in ablation naive regions of the tumors in patients with mesothelioma. cryoablation uses extreme cold to damage or destroy tumor lesions. mesothelioma is a rare cancer that grows and spreads quickly, and has low survival rates. the information learned from this study may provide evidence as to whether there is a measurable, local immune response from cryoablation. studying samples of mesothelioma tissue in the laboratory from patients who have undergone biopsy may help doctors learn more about the effects of cryoablation on cells. it may also help doctors understand how well patients respond to treatment.

primary objectives: i. to evaluate the simple hypothesis that cryoablation of mesothelioma will promote local tumor infiltration by cytotoxic cluster of differentiation 8 positive (cd8+) cells that will not be present in ablation naive regions of the tumors. ii. to determine whether there is a preponderance of t cells in ablated tumor tissue in comparison to non-cryoablated tissue. outline: at the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected.

Eligibility criteria:
inclusion criteria: * adults that have been identified at tumor board with high suspicion for mesothelioma and are anticipated to be surgical candidates, as determined/discussed at mesothelioma tumor board exclusion criteria: * patients that have a questionable diagnosis of mesothelioma (i.e. there are other potentially more likely considerations in the differential diagnosis) or in patients that would not be expected to be good surgical candidates
semilunar coronally positioned flap with or without enamel matrix derivative for the treatment of gingival recessions

Conditions: Gingival Recession

Summary: the aim of this study will be evaluate clinically the use of the semilunar coronally positioned flap (scpf) for the treatment of gingival recessions, with or without enamel matrix derivative (emd). thirty patients will be assigned in two groups. half of patients will receive emd associated to scpf, while the other half, will receive scpf alone.

the aim of this study will be evaluate clinically the use of the semilunar coronally positioned flap (scpf) for the treatment of gingival recessions, with or without enamel matrix derivative (emd). thirty patients will be selected, randomized and allocated in two groups: test group (scpf + emd) and control group (scpf). the subjects will should present buccal miller class i gingival recessions with height greater than or equal to 2.0 mm and less than to 4.0 mm in maxillary canines or premolars. clinical parameters will be evaluated: gingival recession height (grh), gingival recession width(grw), clinical attachment level (cal), probing depth (pd), height (hkt) and thickness (tkt) of keratinized tissue and papillas height (hp) and width(lp), as well as plaque and gingival index. these data will be collected at baseline and 180 days after surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * presence of at least one miller class i gingival recession ≥ 2 mm or ≤ 4mm in maxillary canines or premolars with identifiable cementum-enamel junction (cej); * height of keratinized tissue ≥ 2 mm; * aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus; * full-mouth visible plaque index ≤ 20% (ainamo \& bay 1975); * full-mouth sulcus bleeding index ≤ 20% (mühlemann \& son 1971). exclusion criteria: * smoking; * pregnancy; * presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery); * use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair); * previous periodontal surgery in the area.

Keywords: gingival recession semilunar flap enamel matrix derivative periodontal regeneration
strain analysis as a right ventricle contractility marker

Conditions: Systolic Function

Summary: the analysis of the systolic function (contractility) of the right ventricle (rv) is fundamental and central in many pathologies in intensive care unit. it can guide physicians in choosing therapeutics. the conventional ultrasound markers of rv function evaluation currently used are influenced by rv loading conditions, impairing their capacity to approximate a true contractility analysis. myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate rv systolic function. it is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the rv contractility.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years * patients with renal failure treated with intermittent hemodialysis * patients who received an information and did not opposed to participate in the study, or, if unconscious patient at the time of inclusion: a person of trust as defined in article l. 1111-6 of the public health code, failing that, the family or, failing that, a person maintaining stable link, having received information and not opposed to participate in the study. exclusion criteria: * patients with heart disease (valvular, ischemic, rhythmic) * patients with ejection fraction of left ventricular altered \<45% * chronic dialysis patients * patients referred in articles l. 1121-5, l.1121-6, l.1121-7, l.1121-8 of the public health code: * pregnant women, parturients or nursing mothers * persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research * minor patients * major persons who are subject to a legal protection measure or are unable to express their consent * patients not willing to participate in the study * patients not affiliated to a social security

Keywords: strain myocarditic deformation imaging right ventricle (rv) systolic rv function preload dependence contractility intermittent hemodialysis (hdi)
combination treatment with bosentan and sildenafil to patients with eisenmengers syndrome

Conditions: Eisenmenger Syndrome

Summary: the purpose of this study is to investigate if combination treatment with bosentan and sildenafil to patients with eisenmenger syndrome is beneficial.

eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. when the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (eisenmengers syndrome). several clinical trials have shown that there is a beneficial effect of treating patients with primary pulmonary arterial hypertension with bosentan or sildenafil and that a combination of these may have an additive or even synergistic effect. no clinical trials with sildenafil and bosentan has been conducted for patients with eisenmengers syndrome. observational studies and case stories indicate however that the effect of bosentan or sildenafil in patients with eisenmengers syndrome may be as promising in these patients as in patients with primary pulmonary arterial hypertension. we would like to examine the effect of treating patients with eisenmengers syndrome with a combination of bosentan and sildenafil. the primary end point is change in physical performance measured with six minutes walking test. secondary end points is change in saturation, nyha class, cardiac output (cardiac catheterization and innocor measurement), pulmonary vascular resistance (cardiac catheterization) shunt ratio (mri), strain of right ventricle (bnp and echocardiography), quality of life and serum erythropoitin. the trial is designed as a randomized, single centre, placebo controlled, double blind cross over study. twenty patients with eisenmengers syndrome is included. all patients will be treated in three months with bosentan. there after patients will be randomized to receive either sildenafil (50 mg tid) or placebo as add on therapy for three month. hereafter a cross over will be made and patients in combination treatment will receive only their native treatment and vice versa. examinations for primary and secondary endpoints will be made at baseline, before cross over and at the end of the study. all up titrating of medication will be performed during admittance. patients will during the study period be close monitored with registration of adverse advents, physical examination and blood tests.

Eligibility criteria:
inclusion criteria: * eisenmenger syndrome * negative pregnancy test exclusion criteria: * elevated liver enzymes to more than 3´times normal value * hypotension (sbp \< 90 mmhg). * mandatory treatment with nitrates * myocardial infarction within 3 months * stroke within 3 months * known allergy to bosentan or sildenafil * inherited degenerative diseases in retina * breast feeding * suspicion of risc of noncompliance.
exercise training in women with cardiac devices

Conditions: Cardiovascular Diseases

Summary: cardiac implantable electronic devices (cied) are established treatments for a variety of cardiac arrhythmias. women with cied have lower fitness and lower quality of life compared to men with cied. moderate-intensity continuous training (mict) is the most prescribed exercise for women. however, high-intensity interval training (hiit) has been shown to improve fitness, anxiety levels, quality of life, and other health indicators over mict in men with cied. there is a need to quantitatively evaluate the feasibility and effects of a virtual hiit vs. virtual mict program on the physical, quality of life, and mental health of women with cied. furthermore, a qualitative approach is also necessary to understand patients' experiences, barriers, and facilitators of a virtual exercise intervention. this mixed-methods pilot randomized controlled trial will assess the feasibility of a 12-week virtual hiit and mict program in women with cied.


Eligibility criteria:
inclusion criteria: 1. women (i.e., female sex assigned at birth) with cied (≥6 months since implant) 2. women with cied in optimal medical therapy and functioning; 3. patient is able to perform a symptom-limited cpet; 4. patient is able to read and understand english or french. exclusion criteria: 1. patient is currently participating in routine exercise training (\>2x/week); 2. patient has: documented unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; 3. patient has an unmanaged psychiatric illness (e.g., active psychosis, suicidal ideation) or cognitive impairment; 4. patient does not have an internet connection or a device with a camera and speakers; 5. patient with any device troubleshooting at resting or during exercise; 6. patient is unable to provide written informed consent; 7. patient is unwilling or unable to return for follow-up visits at week 12; 8. patient is unwilling to be randomized to hiit or mict; or 9. pregnancy or patients who become pregnant during the 12-week intervention phase (the effects of interval training on an unborn fetus are unknown).
assessment of heart rate variability, performance and dehydration in muay thai athletes

Conditions: Nervous System Diseases; Dehydration

Summary: known as "thai boxing," muay thai utilizes a combination of upper limb strikes (such as punches and elbow strikes) as well as lower limb strikes (such as kicks and knee strikes), and is thus referred to as the "art of eight limbs." it is practiced worldwide and is a prominent discipline in many mixed martial arts (mma) training camps. in this sport, training load control involves monitoring and adjusting the quantity and intensity of training according to each athlete's capacity. in the context of combat sports, such as muay thai, heart rate variability (hrv) and assessment of body composition by bioelectrical impedance analysis can be used as tools to evaluate training responses. additionally, hrv can also serve as a tool for assessing recovery after training or competition. if hrv does not return to baseline after training or competition, it may be a sign that the athlete is not fully recovered and may need more time to recuperate before returning to training or competition. due to the absence of studies in the literature that have assessed a possible association between hrv and dehydration and rehydration processes in amateur muay thai athletes, it becomes essential to evaluate this correlation. given the growing interest in practicing muay thai in gyms, assessing the sympathetic-vagal balance, body composition, and performance of these athletes becomes of utmost importance. therefore, the aim of this study is to investigate the relationship between dehydration indicators, hrv parameters, and performance in the frequency speed kick test (fskt). participants will be assessed before and after an eight-week training program, conducted three times a week. assessments will include resting hrv measurement and fskt; in addition, bioimpedance will be used to estimate the body composition of participants pre- and post-training. it is expected that the results will reveal changes in hrv, performance, and body composition of the athletes after training.


Eligibility criteria:
inclusion criteria: - 1. amateur muay thai athletes from the city of curitiba and metropolitan region, aged ≥ 18 years old, male. 2. amateur muay thai athletes for a minimum period of 6 months. exclusion criteria: * 1. pregnant women. 2. uncontrolled high blood pressure. 3. inability to perform performance tests 4. interrupting any test spontaneously
test up now education program

Conditions: Colorectal Cancer Screening

Summary: this study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in african americans. the investigators will recruit 250 african americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on colorectal cancer screening outcomes. participants will be randomly assigned to the tune-up intervention or a control group. the tune-up intervention arm will utilize a community health advisor to encourage return of stool blood testing kits through cell phone outreach. the control group will receive educational materials about colorectal cancer screening plus a resource list but no community health advisor counseling support or cellphone / text contact. the primary study outcome is receipt of colorectal cancer screening (colonoscopy or fecal immunochemical test) following the intervention. the secondary outcomes will include colorectal cancer screening knowledge, self-efficacy (confidence to receive colorectal cancer screening), intention to screen, and follow-up in the case of an abnormal test result. the research objective is to test the community health advisor intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened african american population.


Eligibility criteria:
inclusion criteria: 1. are 45 years to 64 years of age 2. self-identify as african american 3. have a working cellphone or telephone 4. are a resident of florida 5. are non-adherent with colorectal cancer screening guidelines (i.e., no stool-based tests \> 9 months, no colonoscopy within 9 years, and no flexible sigmoidoscopy within 4 years) 6. have no personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or crohn's disease). exclusion criteria: 1. under 45 years or over 64 years of age 2. do not self-identify as african american 3. do not have a working cellphone or telephone 4. not a resident of florida 5. are adherent with colorectal cancer screening guidelines (i.e., stool-based tests \< 9 months, colonoscopy within 9 years, and flexible sigmoidoscopy within 4 years) or 6. have a personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or crohn's disease).
ozone therapy in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the aim of this study was to investigate the effects of rectal ozone therapy added to medical treatment on pain severity, disease activity, spinal mobility, functional status, enthesitis, and quality of life (qol) in patients with ankylosing spondylitis (as). patients and methods: patients who fulfilled the modified new york criteria for as were included in this randomized controlled study. thirty patients selected according to inclusion and exclusion criteria were randomized into two groups. rectal ozone treatment along with medical treatment was administered to the patients in group 1, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. the patients in group 2 continued only their current medical treatment. all patients received a comprehensive rheumatologic assessment including pain severity, disease-specific instruments for disease activity, functional status, spinal mobility, enthesitis score, and qol.


Eligibility criteria:
inclusion criteria: * patients who were diagnosed as as according to the modified new york criteria exclusion criteria: * having other concomitant rheumatic diseases, * receiving anti-tnf-α therapy within the last 3 months, * being in clinical remission with standard medical treatment, * being pregnant, * having diseases such as favism, asthma, pancreatitis, and uncontrolled hyperthyroidism for which ozone therapy is contraindicated.

Keywords: ozone therapy complementary treatment
photodynamic therapy in endodontic treatment

Conditions: Endodontic Disease

Summary: this randomized clinical trial evaluated the effectiveness of supplemental photodynamic therapy (pdt) in optimizing the removal of bacteria and endotoxins from primarily infected root canals after one-visit and two-visit treatments.twenty-four primarily infected root canals with apical periodontitis were selected and randomly divided into one-visit (n=12) and two-visit treatments (n=12). chemo-mechanical preparation (cmp) was performed by using the single-file reciprocating technique + 2.5% naocl and a final rinse with 17% ethylenediamine tetraacetic acid (edta). the photosensitizer agent (methylene blue 10 mg/ml) was applied to root canals for 60 seconds and submitted to laser with a potency of 60 milliwatts (mw) and energy density of 129 j/cm2 for 120 seconds after cmp in the one-visit treatment and after 14-day inter-appointment medication with ca(oh)2 + saline solution (ssl) in the two-visit treatment. samples were collected before and after root canal procedures. endotoxins were quantified by chromogenic limulus amebocyte lysate assay. culture techniques were used to determine bacterial colony-forming unit counts.


Eligibility criteria:
inclusion criteria: * single-rooted maxillary ones with primary endodontic infection and showing presence of one root canal and absence of periodontal pockets deeper than 4 mm. exclusion criteria: * those who had received antibiotic treatment during the past three months were excluded. * the teeth that could not be isolated with rubber dam were also excluded. * presence of root canal calcification.
patients with hemorrhoids referred to a surgical specialist department

Conditions: Hemorrhoids

Summary: hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population. this means that many patients are referred to surgical specialist reception with diagnosis hemorrhoidal disease. the aim of this study is to describe population of patients with hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what treatment they are given at a general practitioner as well as in colorectal unit.


Eligibility criteria:
inclusion criteria: * all patients with diagnosis hemorrhoidal disease that are referred to a surgical specialist department exclusion criteria: * none