Kornimate/medical-research-clean huggingface dataset:
registry to evaluate the impact of a valve coordinator on aortic stenosis / tavi outcome - (german pilot)

Conditions: Aortic Valve Stenosis

Summary: prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. the registry will consist of 3 phases: prospective determination of baseline status quo (3 months): documentation of treatment pathways and endpoints of "routine" patients without educational program dedicated reflection and training (1 day): one training session after the observational period to reflect on treatment pathways, exchange between valve coordinators involved, and develop improvements. implementation of tailored changes (2 months): implementation of the changes developed in the training. determination of the effect (3 months): coordinator measures optimization changes and determines effects.

along the severe aortic stenosis (sas) treatment pathway there are delays that may impact quality management and hospital efficiency. a dedicated valve coordinator, interfering with all stages of patient handling throughout the hospital may increase the efficiency of the sas patient flow, accelerate decision making and clinical outcomes while at the same time decreasing resource consumption. the hypothesis is that the implementation of a dedicated valve coordinator will improve the patient flow of sas patients scheduled to undergo tavi, their outcome, patient and physician satisfaction and will optimize costs. in total, three centers across germany (munich, düsseldorf, bad bevensen) will participate.

Eligibility criteria:
inclusion criteria: * elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for tavi exclusion criteria: * patients not providing written informed consent
lch in adults: a collaborative, prospective-retrospective, observational study

Conditions: Langerhans Cell Histiocytosis

Summary: this is a multicenter, retrospective and prospective, observational, no profit study including adult patients with lch, diagnosed starting from january 2001 to two years after the first enrolled patient. each patient will be followed up to one year after the last enrolled patient. each patient will be followed up to one year after the last enrolled patient.this study plans to collect clinical information at the time of diagnosis and at various follow-ups to evaluate the efficacy of first-line therapies. diagnostic and therapeutic data will be collected from routine clinical evaluations and laboratory and instrumental investigations carried out during clinical practice

this is a multicenter, retrospective and prospective, observational, no profit study including adult patients with lch, diagnosed starting from january 2001 to two years after the first enrolled patient. data from patients, diagnosed from january 2001 to the date of patient enrolment, is considered retrospective, while data collected after patient enrolment, and up to two years after the first enrolled patient, is considered prospective. at least one year of follow-up is expected for each patient. each patient will be followed up to one year after the last enrolled patient. this study plans to collect clinical information at the time of diagnosis and at various follow-ups to evaluate the efficacy of first-line therapies. diagnostic and therapeutic data will be collected from routine clinical evaluations and laboratory and instrumental investigations carried out during clinical practice. a sub-cohort of patients with available biological data on somatic mutations of the raf-mek-erk genes will also be evaluated.

Eligibility criteria:
inclusion criteria: * confirmed histological and immunohistochemical diagnosis of lch (cd1a+, s-100+, cd207+), from january 2001 up to two years after the first enrolled patient. patients with isolated vertebra plana, not related to a malignancy, and without a soft tissue component, are included without a histological and immunohistochemical diagnosis; * age ≥18 years at the time of definitive diagnosis; * signed, written informed consent, according to ich/eu/gcp, and national, local laws. exclusion criteria: * age ≥18 years and presumptive diagnosis of lch, or definitive diagnosis of non-langerhans histiocytosis (juvenile xantogranuloma, rosai-dorfman disease, erdheim-chester disease, etc.).
validation of 3 dimensional laparoscopic system in disral pancreatectomy and splenectomy

Conditions: Benign Neoplasm of Body of Pancreas; Benign Neoplasm of Tail of Pancreas

Summary: traditionally, laparoscopy has been based on 2-dimensional (2d) imaging, which has represented a considerable challenge for those approaching this technique. thus, 3-dimensional (3d) visualization technology for laparoscopy has been proposed, since the early 1990s, as a way to facilitate laparoscopic performance. however, early 3d laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. more recently, industry has developed novel 3d systems where the imaging is similar to stereoscopic vision, in which the depth perception is achieved by different unique images received by each eye. thus, more recent studies have suggested a possible advantage provided by these new 3d systems during laparoscopic performance. however, comparative assessments of new generation 3d vs 2d laparoscopy remain limited, especially in the hepatobiliary and pancreatic field. to assess the benefits and harms of use of three dimensional systems versus two dimensional systems during laparoscopic distal pancreatectomy.

procedures 1. the investigators will take the patient consent for this clinical trial. 2. the participants will be divided with two groups with block randomized method 3. skillful pancreatic surgeon will perform 2d or 3d laparoscopic distal pancreatectomy. 4. the participants will be monitor the intraoperative and postoperative course. data collection 1. operation video : operation time, number of errors (missed grasp, loss of material) 1. segmental operation time according to procedure 2. numbers of errors during operation 2. clinical parameters: 1. blood examination : complete blood count (hemoglobin, white blood cell count), amylase, lipase, etc. 2. radiological examination: x-ray, computed tomography (ct), magnetic resonance imaging (mri), etc 3. medical records : hospital stay after operation, the time to eating, pathologic examination 3. subjective scoring in the view of operator, 1st assist. 1. scoring for imaging quality 2. scoring for harms of 3d/2d laparoscopic system 3. scoring for overall demand

Eligibility criteria:
inclusion criteria: * bmi \> 30 (kg/m2) * history of severe or recurrent pancreatitis * mass size \> 10cm * history of low abdomen major operation * additional resection for extra-pancreatic organ exclusion criteria: * participants refusal. * additional resection dependent on pathological examination in intraoperative or postoperative period.
use of minimed 780g system in children and adolescents

Conditions: Diabetes

Summary: hybrid closed-loop technology have shown that it improves glycemic control parameters, but the investigators do not have sufficient data at more than 6 months of follow-up, allowing us to describe the effectiveness of these systems in the long term. all minimed 780g system users from november 2020 to march 2022 were included (n=32) for every time points, there was a significant difference in time in range between the pre-ahcl and post-ahcl. noted difference were +14.5% and, +10.8% at respectively 3 months and 1 year. no more hypoglycemia were identified. this "real-life" analysis shows that the algorithm is effective in improvement of metabolic control for t1 diabetic children and adolescents, at one year of follow-up. however, an effect of breathlessness is observed which underlined the need for a solid therapeutic education program.


Eligibility criteria:
inclusion criteria: all children with type 1 diabetes in whom a medtronic g780 closed-loop pump was placed between november 2020 and march 2022 in our center were included. exclusion criteria: participant opposition

Keywords: advanced hybrid closed loop pediatrics real-world time in range
effect of remote ischemic conditioning on trauma patients with hemorrhagic shock

Conditions: Hemorrhagic Shock

Summary: the purpose of the study is to evaluate whether remote ischemic conditioning is a safe and effective intervention to prevent the development of inflammation and coagulopathy in trauma patients with hemorrhagic shock.

dysfunction of vital organs is one of the major reasons why trauma victims die after sustaining a major injury, even though the organs themselves may not have been directly injured. the inability to clot blood as a result of inflammation further contributes to complications in a majority of these patients. one intervention proposed to protect against impaired organ function is called "remote ischemic conditioning", wherein application of intermittent occlusion and release of blood flow to the arm by sequentially inflating and deflating a blood pressure cuff can protect against the development of distant organ injury and inflammation following a severe traumatic event. in a pilot study, we will investigate the effects of remote ischemic conditioning in trauma patients with hemorrhagic shock, with a view to evaluate its effects on the immune system and coagulation profiles, both of which are known to be deranged in these patients. these studies will potentially benefit patients and will serve as a proof of principle for the use of remote ischemic conditioning in the trauma setting.

Eligibility criteria:
inclusion criteria: * age ≥16 years of age or estimated weight ≥50kgs if age is unknown; * victim of blunt or penetrating trauma * hemorrhagic shock defined as: * one or more episodes of systolic blood pressure ≤90mmhg at any time prior to enrollment into the study; * an identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) or * blood products (rbc, platelets, plasma, etc.) has been ordered to the trauma room. * admitted to st. michael's hospital directly from the scene of injury within 3 hours of the injury * application and completion of remote ischemic conditioning (ric) within 4 hours of the injury exclusion criteria: * pregnancy * non-hemorrhagic shock (i.e. tension pneumothorax, cardiac tamponade, spinal shock, etc.) * major burns \> 20% total body surface area * fracture of both lower extremities (i.e. traumatic amputation, fractures) * absence of vital signs prior to admission, ongoing cpr, possibly dead on admission or not expected to survive beyond a few hours. * injury in both legs (traumatic amputation, fractures, etc.) * patients with a systolic blood pressure above 200mmhg * patients treated with anticoagulants, antiplatelet therapy (warfarin, aspirin), steroids or with a known bleeding disorder or known abnormality of blood flow to the limb (if known) * patients with osteoporosis or other bone disorders, peripheral nerve injury, abnormal nerve supply, peripheral neuropathy (if known) or preexisting traumatic injury to the limb. * morbid obesity (largest cuff size won't fit) * if ric is done clinically before research protocol begins.

Keywords: hemorrhagic shock remote ischemic conditioning
dyspnea and idiopathic pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: longitudinal prospective exploratory study on the evolution of dyspnea, in its sensory and affective dimensions, in patients followed for idiopathic pulmonary fibrosis (ipf), between inclusion and a 6-month evaluation

dyspnea is a multidimensional experience involving a sensory component and an affective component. to better understand this symptom in ipf, this study will describe the different component of dyspnea and their evolution between inclusion and a 6-month evaluation in ipf patients. there is no strong correlation between the intensity of dyspnea and respiratory function impairments. innovative techniques demonstrated abnormalities in ventilation variability and pulmonary compliance in patients with interstitial lung disease. these abnormalities could be more relevant to explain dyspnea. the objective of this work is also to assess the link between the different dimensions of dyspnea and respiratory functional parameters, ventilation variability and ventilatory mechanics measured by impulse oscillometry technique.

Eligibility criteria:
inclusion criteria: * diagnosis of ipf according to ats/ers guidelines * dyspnea at rest (vas ≥ 1) or on exertion (mmrc ≥ 1) exclusion criteria: * diffuse interstitial lung disease other than ipf * other significant chronic pathology that may cause dyspnea: chronic obstructive pulmonary disease, asthma, heart failure, anemia, obesity (non-exhaustive list), except for pulmonary hypertension
trustworthy, integrated artificial intelligence tools for predicting high-risk coronary plaques

Conditions: Coronary Artery Disease; Coronary Computed Tomography Angiography

Summary: coronary artery disease (cad) is among the leading cause of death and disability. identification of patients at high risk of cardiovascular events is pivotal. however, current risk stratification based on imaging and known biomarkers is suboptimal. the objective of this proposal is to develop a multicriteria decision model for non-invasive assessment of vulnerable atherosclerotic patients and to evaluate its ability to predict the occurrence of an adverse event in intermediate-to-high risk patients with suspected or known cad. the planned workflow includes a first step using a retrospective cohort of patients undergoing clinically indicated coronary angiography (ccta) to develop an integrated application for automatic coronary artery segmentation, quantitative plaque analysis, biomechanics and fluid dynamics, based on machine learning, radiomics and computational analysis approaches and validated against the reference standard for each tool. the second step will apply this new methodology to a larger retrospective cohort of patients with the integration of genomic biomarker assessment to derive the most accurate risk stratification model to properly identify vulnerable patients and vulnerable plaques with respect to outcome. finally, in the third step, the derived predictive model will be prospectively validated in an independent cohort of patients from an ongoing study (ctp-pro study) to assess the robustness and accuracy of the proposed solution.


Eligibility criteria:
inclusion criteria: * patients (age ≥ 18 years) with known or suspected cad referred for clinically indicated diagnostic evaluation; * ccta performed with state-of-the-art scanner technology, i.e., scanners with more than 64 slices. exclusion criteria: * performance of any non-invasive diagnostic test within 90 days before enrolment; * low-to-intermediate pre-test likelihood of cad according to the updated diamond-forrester risk model score; * acute coronary syndrome; * evidence of clinical instability; * contraindication to contrast agent administration and/or impaired renal function; * inability to sustain a breath hold; * pregnancy; * cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator; * contraindications to the administration of sublingual nitrates, β-blockers or adenosine; * structural cardiomyopathy
a study to assess the response rate of procrit (epoetin alfa) given at a dose of 40,000 units once a week to cancer patients with anemia who are not receiving chemotherapy.

Conditions: Anemia; Neoplasms

Summary: the purpose of this study is to evaluate the effectiveness and safety of procrit (epoetin alfa) administered at 40,000 units weekly in cancer patients that are not receiving chemotherapy or radiation therapy.

this is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of procrit (epoetin alfa) with regard to hematopoietic response when administered at 40,000 units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study. patients will receive a procrit (epoetin alfa) injection (40,000 units per injection) under the skin once every week for a maximum of 13 weeks. doses may be reduced depending on the patients' hemoglobin level.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of non-myeloid malignancy * baseline hemoglobin value of less than or equal to 11 g/dl unrelated to transfusion * patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. however, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable * female patients with reproductive potential must have a negative serum pregnancy test at screening. exclusion criteria: * uncontrolled hypertension * history (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder * transfusion within 28 days prior to first dose * planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry * no prior treatment with epoetin alfa or any other erythropoietic agent within the previous two months

Keywords: anemia neoplasms hemoglobin values
iul study a randomized sham - controlled clinical study

Conditions: Stress Urinary Incontinence

Summary: primary aim of the study is to compare the impact of sui on the vas (visual analogue scale) 3 months after laser therapy versus sham laser therapy.

background: stress urinary incontinence (sui) has a huge impact on the quality of life (qol) in women and its treatment is challenging. intraurethral laser may be an additional treatment option. study aim: the aim is to study the effectiveness of intraurethral laser therapy in women with sui. design: randomized double blinded sham - controlled clinical study study population: women which have been diagnosed with sui i-ii°, aged between 18-80 years. study groups: participants will be randomized (1:1), without stratification. the intervention group will receive 2 treatments of intraurethral laser therapy and the control group will receive 2 treatments of intraurethral sham laser therapy. sample size: a sample size of 20 women, 8 per group including a 20% drop out rate, was calculated. primary outcome: impact of sui on the vas scale 3 months after laser therapy versus sham laser therapy. secondary study outcomes were defined as subjective sui, objective sui, qol, treatment satisfaction, intraurethral microbiome, 3 months after laser therapy versus sham laser therapy.

Eligibility criteria:
inclusion criteria: * female between 18 and 80 years * confirmed sui through cough stress test within the last 24 months * sui i-ii° for more than 6 months * at least one incontinence episode per 24 hour period measured over three days according to a bladder diary * valsalva leak-point pressure (vlpp) ≤60 cm h2o * maximum cystometric capacity ≥250 ml * no pelvic surgery within last 6 months (including prolapse repair, subjects who have residual or recurrent sui following colposuspension or a sling procedure may be included in the study if the procedure was conducted at least 6 months prior to screening /baseline visit) * bmi (body mass index) ≤35 kg/m2 * willing to give informed consent and complete the follow up schedule exclusion criteria: * active lower urinary tract infections (urethritis, cystitis or vaginitis) * three (3) or more cultured-proven bacterial urinary tract infection (uti) in the last 12 months * detrusor overactivity on urodynamics * postvoiding residual (pvr) \> 100 ml * previous urethral surgery (i.e. fistula or diverticula) * pelvic organ prolapse grade \> 3 as defined by pop-q and symptomatic * known polyuria (\>3l/24h) * unevaluated macro hematuria * neurogenic bladder * evidence of dysplasia in a pap smear (done in the last 24 months) * tumours of the urinary tract * previous radiation or brachytherapy to treat pelvic cancer * uncontrolled diabetes * active herpes genitalis * pregnancy * vaginal delivery within 6 months prior to the screening/baseline visit

Keywords: laser therapy stress urinary incontinence intraurethral
positron emission tomography / magnetic resonance imaging (pet/mri) guided biopsy in men with elevated psa

Conditions: Prostate Cancer

Summary: in 22% of patients with elevated prostate-specific antigen (psa) mri guided biopsy will not detect significant prostate cancer (pca) (defined as either: gleason score (gs) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pt3a and/or pn1). therefore this study evaluates the ability of \[68ga\]psma pet/mri to detect and localize significant primary pca to accurately direct prostate needle biopsy using the gleason score from the histology of the core biopsies as standard of truth.

in this open label, single center, non-randomized, diagnostic study we plan to include 40 men with elevated psa (ages 30-50 psa \>2.5 ng/ml; ages 50-80 psa \> 4ng/ml), which are assigned to a mri guided biopsy. these patients will undergo one additional pet/mri scan with \[68ga\]psma within two to three weeks before the biopsy (arm a), or in case of an unclear/negative mri scan but positive biopsy two to three weeks after biopsy (arm b). in arm a a radiologist will delineate the suspected areas on (a) multiparametric magnetic resonance image (mpmri) and a nuclear medicine physician will delineate and color code the suspicious areas on the pet/mri: (b) \[68ga\]psma. the images will be loaded into the biopsee® system. lesions positive on both modalities will be labeled as "ab". every suspicious lesion will be targeted with 3 cores. a maximum of 3 targets will be selected per patient. for arm b: pet/mri results will be correlated with the template biopsy results. the data analysis of arm a and arm b will be identical. for the analysis the gleason score from the histology of the core biopsies will serve as standard of truth. after completion of the pet/mr study part - an amendment for pet/ct was submitted to the local ethics commity and acknowledged to include 10 more participants with psma pet/ct to investigate the use of pet/ct guided biopsy and intraoperative verivication of the target with a gamma counter.

Eligibility criteria:
inclusion criteria: 1. previously undiagnosed patients with elevated psa (ages 30-50 psa \>2.5 ng/ml; ages 50-80 psa \> 4ng/ml), eligible for prostate needle biopsy. 2. patients can have negative prior needle biopsy(ies) for suspected prostate cancer 3. mpmri with at least one suspicious target lesion (arm a), or negative mpmri but positive biopsy (arm b). 4. written informed consent 5. age \> 30 exclusion criteria: 1. age\> 80 2. contraindication to mri or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with mri, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies) 3. active urinary tract infection or indwelling catheter 4. prior pelvic irradiation 5. prior prostatectomy 6. prior androgen deprivation hormonal therapy 7. prostate biopsy within 8 weeks prior to study 8. prior transurethral resection of the prostate (turp)

Keywords: psma pet/mri guided biopsy prostate cancer