Kornimate/medical-research-clean huggingface dataset:
phase 2a study on allogeneic osteoblastic cells implantation in lumbar spinal fusion

Conditions: Degenerative Disc Disease

Summary: among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and functional improvement. however, pseudarthrosis and failure to relieve low back pain are unfortunately still frequent, irrespective of the type of procedures and grafts used by the surgeon. the present phase 2a study aims at demonstrating the safety and efficacy of allob®, a proprietary population of allogeneic osteoblastic cells, in lumbar spinal fusion.


Eligibility criteria:
inclusion criteria: * ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements * symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (l1-s1) * unresponsive to non-operative treatment for at least 6 months exclusion criteria: * lumbar disc disease requiring treatment at more than one level * previous failed fusion at the involved lumbar level * local active or latent infection at the involved lumbar level * positive serology for hepatitis b, hepatitis c, hiv * current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator

Keywords: spinal fusion lumbar interbody fusion degenerative disc disease cell therapy bone graft
music and vr effects on pain, anxiety, and fear during oral mucositis care in leukaemic children

Conditions: Anxiety; Pain; Fear

Summary: children undergoing leukaemia treatment are exposed to a wide range of chemotherapeutic agents and immunosuppressive therapies during treatment and are therefore at great risk for complications. mucositis is one of the leading chemotherapy-related complications affecting the quality of life of the child. although it varies according to the degree of mucositis, oral mucosal erythema, white plaques and ulcers are extremely painful and traumatising procedures for pediatric patients during mucositis care. the pain and fear they experience during the procedure may lead children to delay/not perform oral mucositis care or not allow their parents to do so. since mucositis is a painful condition in children, it is recommended to use distracting nonpharmacological methods that can help reduce the pain and fear of children during mucositis care. in this context, the aim of this study was to determine the effects of music and virtual reality on pain, anxiety and fear during oral mucositis care in children aged 6-12 years receiving leukaemia treatment. block randomisation (gender (f/m) and age groups (6-9/10-12) will be used to identify participants. five minutes before the oral mucositis care procedure, all participants, regardless of group, will be assessed with the child anxiety scale-disposition (cas-d), child fear scale and visual analogue scale (vas). the study will be conducted in three groups as control group, vr group and music group. descriptive characteristics of dependent and independent categorical variables will be given as number and percentage, numerical descriptive characteristics will be given as mean and standard deviation. in examining the relationship between dependent and independent variables, mann whitney-kruskal wallis or student t-anova analyses will be performed according to the result of the analysis of conformity to normal distribution. bonferroni analysis will be used for pairwise comparisons and covariance analysis will be used to investigate the effect of variables with children.


Eligibility criteria:
inclusion criteria: the participant child * is between the ages of 6-12 years * is being followed up as an inpatient in the paediatric haematology clinic * is receiving leukaemia treatment only * has oral mucositis * does not have a systemic infection * willing to participate in the study * speak turkish and are open to communication * has no visual and hearing problems (not using glasses or hearing aids) exclusion criteria: * cases not fulfilling the inclusion criteria will be excluded from the study.

Keywords: leukemia mucositis fear anxiety pain children nursing symptom management
a trial on the effect on low back pain related disability of different health education programs for retired persons

Conditions: Low Back Pain

Summary: the primary purpose of this study is to compare, in retired persons living in the balearic islands, the effectiveness on low back pain related disability of three educational programs. all consist of a group talk and the handout of a booklet, each one different in its content.


Eligibility criteria:
inclusion criteria: * to attend regular talks for retirees, and accept to attend one health talk, whether or not subject has nonspecific low back pain; to accept participation in the study. exclusion criteria: * inability to fill out questionnaires (due to blindness, functional illiteracy, or dementia); * having a diagnosis of rheumatologic inflammatory disease, fibromyalgia, or cancer in last 5 years.

Keywords: low back pain disability health education
cystoscopy in females: is there a difference between rigid and flex cystoscopy, and does it require local anasthesia?

Conditions: Hematuria; Dysuria; Recurrent Uti

Summary: women arriving to the urology department outpatient clinic at assaf-harofeh medical center in order to undergo a cystoscopy examination will be recruited. patients will be randomly assigned to one of four groups by method of cystoscopy (flexible and rigid) and by use of anesthesia to the introitus. pain levels will be recorded prior to the examination, during entrance of the cystoscope in the urethral meatus, immediately after the examination and 15 minutes after conclusion.


Eligibility criteria:
inclusion criteria: * all women referred to elective outpatient cystoscopy. exclusion criteria: * known urethral stricture. * known allergy to lubricant/anesthesia gel. * patients under the age of 18 (minors). * patients with current urinary tract infections. * chronic pelvic pain (e.g interstitial cystitis/bladder pain syndrome. * known neurlogical or other chronic pain syndrome requiring chronic analgesia medication. * mentally incapable for consensual agreement of participation.

Keywords: cystoscopy
prediction of non-sentinel lymph node metastatic status of breast cancer based on pathology-mri images

Conditions: Breast Cancer; Artificial Intelligence; Lymph Node Metastasis; Digital Pathology

Summary: the goal of this observational study is to develop an artificial intelligence model based on pathology and magnetic resonance imaging (mri) images to predict the metastatic status of non-sentinel lymph nodes in patients with breast cancer sentinel lymph node metastasis. the main questions it aims to answer are: can an artificial intelligence model based on mri images of breast cancer patients predict the non-sentinel lymph node metastatic status in patients with breast cancer sentinel lymph node metastasis? can an artificial intelligence model based on intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastasis status in patients with sentinel lymph node metastasis from breast cancer? can artificial intelligence models based on preoperative mri and intraoperative frozen section images of sentinel lymph nodes in breast cancer patients predict the non-sentinel lymph node metastatic status in patients with sentinel lymph node metastasis from breast cancer? researchers will retrospectively and prospectively collect preoperative mri and intraoperative sentinel lymph node section images from breast cancer patients.


Eligibility criteria:
inclusion criteria: 1. patients with primary breast cancer 2. positive sentinel lymph node biopsy and axillary lymph node dissection. 3. no neoadjuvant chemotherapy, radiotherapy or ablation prior to surgery. 4. mri within 3 weeks prior to surgery. exclusion criteria: 1. recurrent breast cancer or history of surgery or radiation therapy in the axilla 2. inflammatory breast cancer 3. bilateral breast cancer or metastatic breast cancer 4. previous or current history of other malignant tumors 5. sentinel lymph node count \> 5
dysfunction of olfaction after covid-19 infection: morphological and histomolecular investigation

Conditions: Covid19; Olfactory Dysfunction

Summary: investigation of the mechanisms of persistent sars-cov-2 associated olfactory dysfunction (od) in patients with well-documented olfactory function. the investigators plan to collect olfactory cleft biopsies and cytobrushes in covid-19 patients and controls.

an explorative prospective clinical study using human body materials of living post-covid-19 patients with and without od, to study the mechanisms of persisting olfactory dysfunction. patients consult ent specialist for medical purposes and undergo standard-of-care diagnostics and management. the collected tissues from the olfactory cleft mucosa will be analyzed using single cell rna sequencing and rnascope combined with immunohistochemistry.

Eligibility criteria:
inclusion criteria: * olfactory dysfunction group: presence of evident od (parosmia, threshold-discrimination-identification (tdi)-score ≤24, subjective abnormal quantitative olfactory function; measured by a visual analogue score (vas) of smell impairment ≥5/10 * control group: no od (tdi-score \&gt;30.5.) exclusion criteria: * presence of concomitant nasal mucosal pathology that might affect olfactory function or bias the study investigations * use of anticoagulation therapy * allergy to local anesthetics

Keywords: olfactory dysfunction covid-19 sars-cov-2 anosmia hyposmia
study of psychological, sociological and professional factors associated with maintenance of wakefulness test

Conditions: Narcolepsy; Obstructive Sleep Apnea (OSA)

Summary: the predictors of objective impaired alertness assessed by maintenance of wakefulness tests (mwt) are poorly understood. identifying such predictors are essential from a clinical point of view and from a pathophysiological perspective, to better understand the determinants of residual excessive daytime sleepiness (eds) and the complex link between subjective and objective impairments. also, the objective of this study is to describe psychological but also sociological and professional factors associated with maintenance of wakefulness tests results.


Eligibility criteria:
inclusion criteria: * adult (i.e. age ≥ 18 y.o) * referred for maintenance of wakefulness test at lyon university hospital (hcl - croix rousse hospital) exclusion criteria: * do not consent * unable to answer the questionary * cognitive impairments

Keywords: obstructive sleep apnea maintenance of wakefulness test (mvt) anxiety alertness sleepiness narcolepsy
assessment of pulmonary specialty physicians' approach to advanced care planning in patients with chronic pulmonary diseases

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Fibrosis

Summary: to understand current practices of pulmonary physicians in relation to advanced care planning (acp) in order to develop future disease-specific tools that will improve patient-physician communication about acp.

the study will be a retrospective, observational study and analysis of charts of patients with chronic obstructive pulmonary disease (copd) or pulmonary fibrosis treated as outpatients at the ohio state university wexner medical center lung center. using pre-existing data, we will determine if advanced care planning has been discussed with these patients and record this information. for all patients, we will gather data about specific demographic and clinical characteristics that may have contributed to the presence or absence of these discussions. the study is descriptive in nature and is not powered to detect a difference between the two groups. instead, we aim to describe the characteristics most frequently associated with advanced care planning discussion in these two particular groups. potential subjects will be identified with assistance from the information warehouse. after identification, data will be abstracted from pre-existing data in the electronic medical record and collected in a coded fashion for each subject. each subject will be assigned an anonymous subject identification number and all links to identifying information will be destroyed prior to analysis. all study data will be stored on a secure password protected data base to which only study personnel will have access.

Eligibility criteria:
inclusion criteria: 1. patients who are between 18 and 88 years of age who have been diagnosed with a physician diagnosis of copd based on at least one of the following: * clinical history - a documented history of copd, emphysema, or chronic bronchitis. * pulmonary function results - defined as an forced expiratory volume in one second to forced vital capacity ratio (fev1/fvc) less than 0.7 2. patients who are between 18 and 88 years of age and have been diagnosed with pulmonary fibrosis based on the following: * subpleural, basal predominance of parenchymal abnormality on high resolution computed tomography (hrct) * reticular abnormality on hrct * honeycombing without traction bronchiectasis on hrct * absence of features that are inconsistent with usual interstitial pneumonia (uip) pattern or * uip based on surgical lung biopsy exclusion criteria: * age \ 88 years * prisoners * pregnant patients

Keywords: chronic obstructive pulmonary disease pulmonary fibrosis advanced care planning
the comparison of the 3 minutes ramp walk test with 6 minutes walk test in stable patients after valve replacement

Conditions: Prosthetic Replacement of Mitral Valve; Abnormality of Aortic Valve

Summary: in view of assessing the uphill walking capacity and to provide a functional stress test with better sensitivity the investigators need a short term functional stress test over the gold standard six minute walk test.... to demonstrate the significance of 3 minutes ramp walk test over 6 minutes walk test as a functional stress test. the investigators hypothesize that the investigators three minutes ramp walk test (3mrwt) will be superior to the existing six minutes level walk test (6mwt) in the measurement of functional capacity of post valve replacement patients.

the patients who have undergone valve replacement surgeries face difficulty in their functional activities especially during climbing stairs, walking uphill. the six minute level walk test has been a gold standard in the assessment of functional capacity in cardio respiratory conditions like, coronary heart diseases , valvular heart diseases, chronic respiratory illness. moreover, six minute walk test has been framed to assess the functional capacity in level walking.so far, no test have been developed to assess the functional capacity of the patients during uphill walking and stair climbing. though ramp walking ( uphill walking) can be trained using treadmill, it is not feasible for the indian patients as they are not familiar in the treadmill and their fear may also show variation in the functional assessment. hence this study has been proposed..

Eligibility criteria:
inclusion criteria: * both genders * 30 to 65 years * patient in step down unit(5th post operative day) * aortic and mitral valve replaced patients exclusion criteria: * vitally unstable patients, \[pyretic, abnormal bp, spo₂, x-ray and pain\] * any arrthymia * orthopaedically disabled patients * neurologically impaired patients * patients with psychologically impaired
study on standard evaluation system and optimal treatment path of senile valvular heart disease

Conditions: Valvular Heart Disease

Summary: the key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous chinese elderly valve disease cohort and clinical research platform and the national valve disease surgery data platform.

establish clinical and imaging database

Eligibility criteria:
inclusion criteria: patients with heart valve disease who are ≥ 65 years old and diagnosed by echocardiography meet the requirements one of the following criteria: * (1)severe mitral stenosis: valve orifice area \< 1.0cm2; * (2)severe mitral regurgitation: constriction neck width ≥ 7mm, or regurgitation per beat (regurgitation volume)≥ 60ml, or reflux beam area / left atrial area \> 50%; or effective reflux port area (eroa) ≥ 0.4cm2; * (3)severe aortic stenosis: mean cross valve pressure difference ≥ 40mmhg, or maximum jet velocity ≥ 4m / s, orvalve orifice area \< 1.0cm2, it should be differentiated from left ventricular outflow tract stenosis; * (4)severe aortic regurgitation: constriction neck width \> 6mm, or each pulsation regurgitation ≥ 60ml, or regurgitation flow fraction ≥ 50%, or jet width ≥ 65% of left ventricular outflow tract, or effective reflux orifice area (eroa) ≥0.3cm2； * (5)severe tricuspid stenosis: mean cross valve pressure difference ≥ 5mmhg; * (6)severe tricuspid regurgitation: constriction neck width ≥ 7mm, or effective regurgitation orifice area (eroa)≥0.4cm2； * (7)severe pulmonary stenosis: the forward blood flow velocity is ≥ 4m / s, which should be differentiated from right ventricular outflow tract stenosis; severe pulmonary valve regurgitation: massive regurgitation, wide constriction neck exclusion criteria: * patients unwilling to accept registration and follow-up; * patients with mental illness who cannot cooperate with information collection and follow-up
cell-free dna analysis of chromosome anomalies in early pregnancy loss

Conditions: Early Pregnancy Loss

Summary: the study assesses the accuracy of cell-free dna (cfdna) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.


Eligibility criteria:
inclusion criteria: * 5-20 weeks of gestation by ultrasound * miscarriage diagnosed by ultrasound * pregnancy tissue still present in utero, including an empty sac, and not completely expelled exclusion criteria: * maternal age \< 18 years * no visible pregnancy tissue on ultrasound * multiple fetal gestation (\> than singleton) * pregnancy was conceived using in vitro fertilization (ivf) with preimplantation genetic testing for aneuploidy (pgt-a) performed on the transferred embryo * no microarray testing is planned on the product of conception * previous normal non-invasive prenatal testing (nipt) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy * patient unable to provide consent
azithromycin as host-directed therapy for pulmonary tuberculosis

Conditions: Tuberculosis, Pulmonary

Summary: rationale: treatment in tuberculosis (tb) is focused on eradication of the bacterial infection, however, after treatment approximately half of patients are left with a significant and permanent respiratory impairment. adjunctive host-directed therapies are being investigated to modulate host immune responses to target mycobacterium tuberculosis (mtb) infection and/or reduce excessive inflammation, prevent pathological tissue damage, preserve lung function and enhance effectiveness of standard drug therapy, while nonetheless eliminating mtb. macrolide antibiotics have previously been used in the treatment of multidrug-resistant tb. in addition to their antibiotic effects, macrolides have also been recognized to induce anti-inflammatory and immunomodulatory effects in other lung diseases. objective: to investigate the immunomodulatory effects of azithromycin in tuberculosis patients receiving standard therapy (isoniazid, rifampicin, pyrazinamide, ethambutol (hrze)) study design: a prospective, randomized open label intervention trial to investigate the immunomodulatory effects of azithromycin study population: 24 intervention: azithromycin 250 mg once daily or standard of care (control) main study parameters/endpoints: 1. to assess whether azithromycin enhances resolution of systemic inflammation in patients with drug susceptible pulmonary tb receiving standard treatment. 2. to assess whether azithromycin on top of standard treatment in patients with drug susceptible pulmonary tb reduces airway inflammation and reduces tissue degradation and remodeling 3. to investigate whether these effects are associated within shortening of the time to sputum conversion.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of drug sensitive pulmonary tuberculosis (molecular test; identification mtb complex; absence of resistance genes such as rpob, inha, katg) * written informed consent exclusion criteria: * patient reported previous history of treatment for tuberculosis * patients younger than 18 years * pregnancy or breast feeding * patients with hypersensitivity to macrolide antibiotics * treatment with any macrolide in the previous month * treatment with any tetracycline in the previous month * treatment with any inhaled or oral corticosteroid in the previous month * concomitant treatment with analgesic (nsaids)/immunosuppressant drugs (except paracetamol). * treatment with digoxin * patients with gastrointestinal complaints, like diarrhea and vomiting (≥grade 2, observed) * other known respiratory diseases, including bronchiectasis, pulmonary fibrosis, pulmonary vascular disease or lung cancer * hiv-1 infection or aids * impaired liver function (child-pugh score c) * patients with a known qtc ≥500 ms. an electrocardiogram (ecg) will be recorded. * inability to spontaneously produce sputum upon diagnosis

Keywords: azithromycin immunomodulation pharmacokinetics tissue degradation tissue remodelling
hyperbaric oxygen therapy combined with polarized light therapy effect on neuropathic foot ulcer

Conditions: Neuropathic Diabetic Ulcer - Foot

Summary: neuropathic ulcers develop due to nerve damage (neuropathy), commonly seen in conditions like diabetes, leading to loss of sensation, repetitive trauma, and poor wound healing. these ulcers typically occur on weight-bearing areas, hyperbaric oxygen and polarized light therapies may have a synergistic effect, improving oxygenation, cellular activity, and overall healing outcomes in neuropathic ulcers, particularly in diabetic foot ulcers.


Eligibility criteria:
inclusion criteria: * all patients had cardiac ejection fraction (cef) 50% * blood pressure (bp) 150/90mmhg. * chest x-ray was reported normal * all patients were clinically evaluated by a specialized ear, nose, and throat (ent) physician to ensure suitability for the hyperbaric chamber. exclusion criteria: * chronic obstructive pulmonary disease, malignancy * cardiac pacemakers, or any disorder that lead to ulcers other than diabetes * chronic peripheral arterial disease.

Keywords: hyperbaric oxygen therapy polarized light therapy neuropathic foot ulcer