Kornimate/medical-research-clean huggingface dataset:
assessing the stability of uterine scar tissue in women with previous history of caesarean section using multimodal analyses of the lower uterine segment including quantitative sonography

Conditions: Scar; Previous Cesarean Section

Summary: this prospective, clinical, observational trial compares the measured value with quantitative ultrasonic (preoperatively) elastic modulus e (kpa) with the measured value with quantitative ultrasonic elastic modulus e (kpa) in vitro (postoperatively) and with the experimental measurement done in vitro (postoperatively) of lower uterine segment of women who underwent second cesarean section.

in 1991, 126.297 (15.3%) women delivered by caesarean section in germany. since then, the rate of caesarean section increased steadily over the next 20 years, reaching up to 32.2% in 2011. the absolute risk of uterine rupture in vaginal birth after caesarean section is 1 in 100 deliveries. the risk of perinatal death or the outcome of extremely neurological impairment is 1 in 1000 deliveries. statistically more than 300 pregnant women with a prior caesarean delivery visit daily ultrasound departments of german hospitals to investigate the c-section scar before delivery. they have one important question: is it possible to predict successful trial of labor after cesarean delivery? the information for the risk of uterine rupture remains insufficient based only on ultrasonography assessment. what are the possibilities of additional parameters to examine the stability of uterine scar tissue? currently, there is no defined cut-off value of scar thickness for the prediction of uterine rupture. it remains questionable whether the thickness of the lower uterine segment is the determinant factor for the stability of the scar and the probability of rupture. however, another important factor is the functional elasticity or the structure of the connective tissue. it has not been further investigated until now (both quantitatively and qualitatively). objective of this project: multimodalities of assessments, including ultrasonography and elastography, validate the accuracy of uterine scar stability in women with previous history of caesarean section in vitro and in vivo.

Eligibility criteria:
inclusion criteria: * pregnancy after previous cesarean section * pregnancy between 37 0/7 and 42 0/7 weeks of gestation * primary or secondary indication for cesarean section * ability to give informed consent in german or english exclusion criteria: * emergency caesarean section * \<18 years old

Keywords: repeat cesarean section lower uterine segment quantitative sonography
comparison of ultrasound-guided electrolysis therapy vs. sham electrolysis in patients with patellar tendinopathy: a prospective randomized study including mri and shear-wave ultrasound elastography imaging

Conditions: Patellar Tendinopathy / Jumpers Knee

Summary: study background and purpose tendinopathies are common and debilitating musculoskeletal disorders that often lead to chronic pain and reduced mobility. traditional treatments face challenges due to limited tendon blood supply, leading to poor healing. this study investigates ultrasound-guided galvanic electrolysis therapy (usget), which uses electric current to promote tendon healing, comparing its efficacy with a placebo. objectives the primary goal is to assess pain reduction, while secondary goals evaluate functionality, elasticity, and morphological changes (imaging) in patients with patellar tendinopathy. methodology * design: prospective, randomized, double-blind, placebo-controlled study. * duration: 24 months (october 2024 - october 2026). * groups: * intervention group: electrolysis therapy with galvanic current, progressive tendon-loading exercises. * control group: electrolysis placebo (without current), progressive tendon-loading exercises. * sample size: 74 subjects. * data collection: baseline, post-treatment (4 months), and follow-up (7 months). evaluation and data analysis the study assesses pain via vas and functionality scores, alongside imaging (mri, sonography) to measure tendon morphology. statistical analysis includes hypothesis testing and regression using spss software. ethics and publication ethics approval is from the bremen medical chamber. results will be published regardless of outcome, following good clinical practice and the declaration of helsinki.


Eligibility criteria:
inclusion criteria: * age: 18 - 59 years, * informed consent (capable of giving consent), * presentation and diagnosis of patella tendinopathy without other concomitant musculoskeletal diseases or degenerative joint disease. exclusion criteria: * children (\ 59 years, * pregnancy and breastfeeding, * patients who are unable to give consent, * musculoskeletal concomitant diseases such as fractures, sprains, dislocations, structural muscle injuries, meniscopathies, cruciate ligament injuries, * joint diseases (acute, degenerative) such as arthrosis or arthritis, * acute infections / open wounds in the area of the tendon to be examined * other relevant damage to the tendon to be examined * local steroid injections into the tendon before and after the start of the study, * injections of vascular sclerosing agents before and after the start of the study, * ingestion of fluoroquinolones, anticoagulants or anti-inflammatory drugs.

Keywords: patellar tendinopathy jumpers knee ultra-sound-guided-electrolysis electrolysis galvanic current usget
efficacy of peek acuity versus etdrs chart for assessment of visual acuity and refractive error

Conditions: Refractive Errors

Summary: visual acuity is a key indicator of visual function, often measured using the etdrs chart, the gold standard in clinical settings. however, the increasing need for accessible and cost-effective screening tools, especially in underserved areas, has led to the development of mobile health applications like the peek acuity application.

this study aims to compare the diagnostic accuracy and efficiency of the peek acuity application (portable eye examination kit) with the etdrs (early treatment of diabetic retinopathy study) chart in assessing visual acuity and refractive errors. the study will involve 58 participants, selected using a non-probability convenience sampling technique. a comparative cross-sectional design will be used.

Eligibility criteria:
inclusion criteria: * males and females. * 18 years of age or older. * individuals with normal vision or those with refractive error who had their corrected glasses. * individuals who are willing and able to provide written informed consent to participate in the study. exclusion criteria: * individuals with anterior segment abnormalities such as conjunctivitis, iritis, uveitis, keratitis, or corneal ulcers. * individuals with vision deprivation due to corneal opacities, cataracts, glaucoma, retinal, and optic nerve pathologies. * postoperative/intraoperative complications. * have received mydriatic drops. * individuals who cannot achieve normal visual acuity with corrective lenses (glasses or contact lenses). * individuals with neurological conditions affecting vision * individuals unable to cooperate with visual acuity testing due to cognitive impairments or language barriers. * individuals who have had refractive surgery or other eye treatments within the past 6 months.
a 5-year superion™ ids clinical outcomes post-approval evaluation (scope)

Conditions: Lumbar Spinal Stenosis

Summary: to compile real-world outcomes of the superion™ ids in routine clinical practice.

to compile real-world outcomes of the superion™ ids in routine clinical practice, when used according to the applicable directions for use

Eligibility criteria:
key inclusion criteria: * 45 years of age or older when written informed consent is obtained * persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart). * diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (sap), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal). * subject signed a valid, irb-approved informed consent form (icf) provided in english. * subjects, who, in the opinion of the clinical investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups. * able to independently read and complete all questionnaires and assessments provided in english key exclusion criteria: * axial back pain only. * fixed motor deficit in lower extremity(ies) due to lss. * has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor) * participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Keywords: lumbar spinal stenosis lss chronic pain leg pain
maternal embryo interaction in recurrent miscarriages

Conditions: Recurrent Miscarriages

Summary: background of the study: the etiology of recurrent miscarriage (rm, defined as three or more consecutive miscarriages without any proven maternal or fetal cause), remains undiagnosed in more than 50% of cases. in these cases it is generally considered that a disturbance in the normal mother-embryo interactions is a causal factor. this disturbance may be based on a dysregulation of embryo invasiveness and/or decidual acceptance (e.g. altered decidualization; endometrial changes in preparation for the acceptance of a putative pregnancy). moreover, dysfunctional maternal immune regulatory natural killer (nk) cells, implicated in tolerance induction and trophoblast invasion,may also underlie the occurrence of rm. the selection failure hypothesis for rm suggests that super-receptive endometrium (possibly due to increased embryo invasiveness and/or decidual acceptance and/or dysregulated immune cell function) may allow 'poor quality' embryos to implant and present as a clinical pregnancy before miscarrying. fundamental knowledge on mechanisms of embryo implantation, decidual function and maternal immune reactivity in successful pregnancies has accumulated over the past 5 years. this study aims to investigate whether dysregulation of (one of) these mechanisms may underlie rm. objective of the study: to test the selection failure hypothesis by assessing a) the degree of embryo invasiveness and decidual acceptance (the quality of decidualization, endometrium-embryo communication and endometrial stromal cell (esc) migration) and b) the angiogenic capacity of decidual nk (dnk) cells, in order to elucidate the pattern of the mother-embryo equilibrium in women with rm.


Eligibility criteria:
inclusion criteria: 1. women with unexplained recurrent miscarriages (three or more first trimester miscarriages). 2. proven fertile women (at least 1 successful pregnancy and no more than 1 miscarriage). 3. age 18 - 40 years. 4. willing and able to give informed consent. exclusion criteria: 1. any identifiable causes of recurrent miscarriages; antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[igg or igm\]), other recognised thrombophilic conditions (testing according to usual clinic practice), intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram or hysteroscopy), submucous fibroids and tests initiated only if clinically indicated such as tests for diabetes, thyroid disease and sle 2. undergoing treatment (hormonal) 3. women using oral contraception or having an intra uterine device.

Keywords: recurrent miscarriages (rm) recurrent pregnancy loss (rpl) fetal-maternal interface decidualization co-culture implantation immune regulation
study evaluating the safety, efficacy & pharmacokinetics of temsirolimus(cci-779) in subjects with advanced renal cell carcinoma

Conditions: Advanced Renal Cell Carcinoma

Summary: this is a study to evaluate the safety, efficacy and pharmacokinetics of temsirolimus in asian patients with advanced renal cell carcinoma. the trial is only being conducted in japan, korea, and china.


Eligibility criteria:
inclusion criteria: * subjects with histologically confirmed, advanced (stage iv or recurrent disease) rcc. the american joint committee on cancer (ajcc) staging and classification criteria will be used. * ecog performance status of 0-1. * at least one measurable lesion per recist. * age greater than or equal to 20 years. * japanese, chinese, or korean ethnicity. exclusion criteria: * cns metastases at screening or history or cns metastases. * prior targeted, chemotherapeutic, cytokine-based, or other investigational agents for the treatment of rcc within 4 weeks before first dose of test article. subjects must have documented objective progressive disease after any prior systemic rcc treatment and have recovered to grade 1 or lower toxicities from effects of prior systemic therapy for rcc. * in past 5 years, other prior malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ).
impact of a strategy based on bacterial dna detection to optimize antibiotics in immunocompromised patients with hospital-acquired pneumonia requiring mechanical ventilation

Conditions: Pneumonia, Ventilator-Associated; Pneumonia, Hospital-Acquired; Immunodeficiency

Summary: respire is a randomized, unblinded, controlled study to measure the impact of a strategy based on a pcr test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (vap/hap) requiring mechanical ventilation (mv) in intensive care unit (icu). the gold-standard microbiological diagnostic method for pneumonia in the icu is based on culture identification and antimicrobial susceptibility testing. results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. we aim to measure the impact of a pcr-based strategy to improve the percentage of patients with vap or hap receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care


Eligibility criteria:
inclusion criteria: * adult immunocompromised patients hospitalized in icu with suspected vap or hap requiring mv exclusion criteria: * no immunodeficiency moribund patients (saps ii \> 90) pregnant women refuse to participate to the study

Keywords: ventilator-associated pneumonia hospital-acquired pneumonia immunodeficiency antimicrobial therapy polymerase chain reaction (pcr)
kidney recovery after acute kidney injury - longitudinal study

Conditions: Acute Kidney Injury; Chronic Kidney Diseases

Summary: the endothelin (et) system is an active target in human acute kidney injury (aki). our primary hypothesis is that the circulating blood concentration of et will be higher in patients with aki than in matched controls.

acute kidney injury (aki) is a major health problem being both common and costly. it affects \~20% of hospital inpatients and consumes \~1% of the annual nhs budget. aki occurs following a diverse range of insults, commonly ischaemia-reperfusion injury (iri) but also sepsis and drug toxicity. therapies for aki are currently supportive and short-term mortality remains high, with \~2 million deaths per year worldwide. in those who survive an episode of aki, 30% are left with chronic kidney disease (ckd). the remaining 70% that recover full renal function are at \~28-fold increased risk of ultimately developing ckd. this risk is even greater in elderly patients. importantly, ckd is strongly and independently associated with incident cardiovascular disease (cvd), and together these exert a global socioeconomic burden. the recognition that aki and ckd are linked is recent and the molecular pathways that control the transition from acute injury to chronic disease are not well defined. currently, there are no specific treatments that reduce the risk of progressing to ckd after aki. thus, there is an unmet need for therapies that will prevent the transition from aki to ckd and reduce the cardiovascular burden associated with both. our preliminary investigations (not yet published) in humans and mice suggest that aki causes sustained activation of the endothelin (et) system to the long-term detriment of renal and systemic haemodynamic function. these pilot data form the basis of our project that seeks to determine whether the et system is active in patients with aki and, thus, represents a potential target for therapeutic intervention.

Eligibility criteria:
inclusion criteria: (i) adult aged 16 or over; (ii) ability to provide informed consent; (iii) diagnosis of aki determined as: * previous (within 3 years) egfr \>45 ml/min/1.73m2 or no history of kidney disease if no recent (within 3 years) blood results available and * elevated creatinine over 1.5 x previous result or over 150 μmol/l if no previous value and * increasing creatinine \>= 27μmol/l above index value within 48 hours the control group (n=50) inclusion criteria are: (i) adult aged 16 or over; (ii) ability to provide informed consent; (iii) admitted to hospital without aki: (egfr \> 60) this group will be recruited contemporaneously with, and matched to, aki participants by: 1. age (± 5 years) 2. sex 3. aki aetiology (ischaemic, infected, nephrotoxic) 4 (i) history of diabetes or not and/or (ii) history of cardiovascular disease or not exclusion criteria: 1. inability to provide informed consent 2. prisoners 3. pregnancy or breast feeding 4. evidence of ckd
endoscopic treatment of gastroesophageal reflux disease

Conditions: Gastro Esophageal Reflux Disease

Summary: gastroesophageal reflux disease (gerd) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). this backwash (acid reflux) can irritate the inner lining of the esophagus. this is a particular problem after surgery to reduce obesity called gastric sleeve resection. the goal of this small clinical trial is to examine the effect of endoscopic treatment of gerd by mucosal band ligation. the main questions it aims to answer are: * does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux * does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors) participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of gerd. suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. the effects will be assessed three and six months after the procedure.

gastroesophageal reflux disease (gerd) is very common after gastric sleeve resection and many patients are dependent on daily use of proton pump inhibitors (ppis). the goal of this small clinical trial is to examine the effect of endoscopic treatment of gerd by mucosal band ligation. patients (n=12) with gerd satisfying inclusion and exclusion criteria will be invited to participate and the degree of gastroesophageal reflux will be assessed before treatment, and three and six months after the procedure. the results of the trial will be used to plan a larger study.

Eligibility criteria:
inclusion criteria (all criteria must be fulfilled): * previous gastric sleeve resection * gerd. gerd must be diagnosed by either endoscopic esophagitis or esophageal ph measurement with demeester score \> 14.72 and ph \ 95% * subjective insufficient symptom control with ppi therapy once daily or intolerance to ppi or desire to stop ppi treatment and therefore willingness to undergo endoscopic treatment. exclusion criteria: * hiatal hernia \> 5 cm * age \< 18_years * preexisting esophageal stricture * gastric stricture \< 2 cm in diameter * anti-coagulant medication * use of platelet inhibitors other than acetylsalicylic acid * manometric indication of motility disorder * connective tissue diseases * bmi \> 35 * liver cirrhosis * coronary heart disease * chronic obstructive pulmonary disease * other significant comorbidity * indication for long-term ppi use other than gerd
a study of ibrutinib in the treatment of chronic lymphocytic leukemia and mantle-cell lymphoma in routine clinical practice

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell

Summary: the purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (cll) and mantle-cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: * has a confirmed diagnosis of chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll) or mantle-cell lymphoma (mcl), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 november 2014 (date of ibrutinib commercialization) for: 1. treatment of cll/sll in participants who have received at least 1 prior therapy; or 2. treatment in first line cll/sll participants in the presence of deletion (del) 17p or tp53 mutation in participants unsuitable for chemo-immunotherapy; or 3. treatment of participants with relapsed or refractory mcl * not currently participating in another investigational study, clinical study, or any expanded access program at study entry * has not participated in the ibrutinib autorisation temporaire d'utilisation (atu) program * participant must sign a written informed consent form (icf) allowing data collection and source data verification exclusion criteria: * currently participating in another investigational study, clinical study, or any expanded access program at study entry * participated in the ibrutinib autorisation temporaire d'utilisation (atu) program
study of dna in blood samples from patients with neuroblastoma

Conditions: Disseminated Neuroblastoma; Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Recurrent Neuroblastoma; Regional Neuroblastoma; Stage 4S Neuroblastoma

Summary: this research trial studies is deoxyribonucleic acid (dna) in blood samples from patients with neuroblastoma. studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

objectives: i. perform in a blind study a multicentric study by analyzing serum from patients at diagnosis (with a known tumor v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (mycn) status determined in the children's oncology group \[cog\] reference lab), in order to confirm our previous data and to define the most appropriate mycn/control ratio cutoff capable of determining positive and negative cases. ii. define the limits of the procedure in non-metastatic patients and in those with reduced tumor burden (international neuroblastoma staging system \[inss\] stage 1 and 2). outline: circulating dna is extracted from serum. polymerase chain reaction (pcr) amplification of mycn is performed and analyzed by agarose gel electrophoresis. real-time quantitative pcr is also performed.

Eligibility criteria:
inclusion criteria: * serum samples from neuroblastoma (nb) patients obtained through the cog (and legacy children's cancer group \[ccg\]/pediatric oncology group \[pog\] biology studies) * the mycn status on corresponding tumors have been determined using standard techniques; the panel of samples must be obtained from nb patients with and without mycn amplification tumors * cases will be drawn from clinical subsets at greatest likelihood to benefit from this testing ability, stage 1 and 2 nbs (both infants and toddlers), stage 4 patients under 18 months of age, and 4s patients