Kornimate/medical-research-clean huggingface dataset:
patient-centered outcomes in the surgical treatment of uterovaginal prolapse

Conditions: Uterine Prolapse

Summary: the purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.

this is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either a) a minimally invasive supracervical hysterectomy with sacrocolpopexy (mi-sch+scp) or b) total vaginal hysterectomy with uterosacral ligament suspension (tvh+usls). after surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. a subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.

Eligibility criteria:
inclusion criteria: 1. women ≥ 18 years of age and ≤ 80 years of age 2. have diagnosis of symptomatic uterovaginal prolapse 3. have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician 4. are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (mi-sch+scp) and total vaginal hysterectomy with uterosacral ligament suspension (tvh+usls) exclusion criteria: 1. patients who wish to undergo uterine sparing procedures 2. body mass index bmi) \> 50 3. previous hysterectomy or prior uterovaginal surgery 4. have a diagnosis of neurogenic bladder, parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident 5. chronic indwelling urinary catheter 6. urinary diversion of any type 7. any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results 8. unable to speak, read, understand english

Keywords: sacrocolpopexy uterosacral ligament suspension
probiotics for prevention of ventilator-associated pneumonia (vap)

Conditions: Drug Safety

Summary: hospitalized patients with ventilator are randomized to receive fermented dairy product containing l. casei shirota or nothing. the main outcome is development of ventilator-associated pneumonia (vap)

fermented dairy product containing l. casei shirota has bee shown to inhibit multi-drug-resistant bacteria. this study is conducted to determine if fermented dairy product containing l. casei shirota can prevent ventilator-associated pneumonia.

Eligibility criteria:
inclusion criteria: patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form exclusion criteria: immunocompromised host (e.g. hiv infection, on immunosupressive agents, anc ≤ 500 cell/ml), pregnancy, history of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, contraindication for enteral feeding, history of milk or milk-product allergy
midas i (mild® decompression alternative to open surgery): vertos mild patient evaluation study

Conditions: Lumbar Spinal Stenosis

Summary: this is a multi-center, prospective, clinical study to assess the clinical application and outcomes of mild® interlaminar decompression in patients with symptomatic lumbar spinal stenosis.


Eligibility criteria:
inclusion criteria: * symptomatic lumbar spinal stenosis (lss) primarily caused by dorsal element hypertrophy. * prior failure of conservative therapy. * radiologic evidence of lss (l3-l5), ligamentum flavum \> 2.5mm, confirmed by pre-op mri and/or ct. * central canal cross sectional area ≤ 100 square mm. * anterior listhesis ≤ 5.0mm. * able to walk at least 10 feet unaided before being limited by pain. * available to complete 12 weeks of follow-up. * consistent with the intended labeling statement for use. * able to use all package components to perform the procedure. * a signed informed consent form is obtained from the patient. exclusion criteria: * prior surgery at intended treatment level. * history of recent spinal fractures with concurrent pain symptoms. * disabling back or leg pain from causes other than lss (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). * significant / symptomatic disk protrusion or osteophyte formation. * excessive / symptomatic facet hypertrophy. * bleeding disorders and/or current use of anti-coagulants. * use of acetylsalicylic acid (asa) and/or non-steroidal anti-inflammatory drug (nsaid) within 5 days of treatment. * epidural steroids within prior three weeks. * inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (copd), obesity, etc.). * any potential wound healing pathologies that may compromise outcomes, including diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe copd. * dementia and/or inability to give informed consent. * pregnancy. * intended treatment that is defined by the product labeling contraindications. * on workman's compensation or considering litigation associated with back pain.

Keywords: spinal stenosis lumbar spinal stenosis
low level laser therapy for the treatment of provoked vestibulodynia

Conditions: Provoked Vestibulodynia

Summary: provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule in response to contact or pressure. in addition, many patients also have pain in response to non-sexual activities such as tampon insertion, gynecological examinations or physical pursuits such as bicycle riding; the severity of other vulvo-vaginal symptoms such as itching, burning and irritation varies. once women with provoked vestibulodynia develop the syndrome, symptoms may last for months or years; as a result, provoked vestibulodynia has a profound effect on women's sexuality and psychological well-being. the diagnosis of provoked vestibulodynia is usually made by ascertaining if the patient fulfills modified friedrich's criteria, consisting of 1) a history of vulvar pain, dyspareunia or pain with tampon insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator and 3) no identifiable cause for the pain. the etiology of this condition remains unknown. proposed causes include chronic inflammation, peripheral neuropathy, genetic, immunologic and hormonal factors, infectious, psychological disorders, sexual dysfunction or disturbance in the central nervous system. because the cause of provoked vestibulodynia remains unknown, many different treatments have been described for this condition, including topical and intra-lesional corticosteroids, topical anesthetics such as lidocaine, topical estrogen, topical or oral antidepressants or anti-convulsants, biofeedback or physical therapy, surgical resection of the involved tissue (vestibulectomy) and a variety of complementary and alternative therapies. low level laser therapy (lllt) is an emerging medical technique in which exposure to low-level laser light or light emitting diodes might stimulate or inhibit cellular function, possibly leading to beneficial clinical effects. clinical applications that show some potential of effectiveness include treating soft tissue injury, chronic pain, and wound healing. the usage of low level laser therapy was found effective in various pain syndromes, and has no side effects. since inflammatory mechanisms have been proposed in the pathogenesis of provoked vestibulodynia, and as there is no effective therapy for this syndrome, the investigators intend to study whether low level laser therapy might be an effective therapy for provoked vestibulodynia.


Eligibility criteria:
inclusion criteria: * patients with provoked vestibulodynia who meet modified friedrich's criteria, after exclusion of other vulvar disorders, who are willing to participate in the study. exclusion criteria: * pregnancy

Keywords: provoked vestibulodynia low level laser therapy
prostate histoscanning for the non-invasive detection and staging of prostate cancer and characterization of prostate tissues (phs-02)

Conditions: Prostate Cancer

Summary: study design: -the study will be a phase i like study to assess the extent to which prostate histoscanning (phs, the index test) can identify and characterize foci of prostate cancer when compared to histological samples harvested during radical prostatectomy (the reference test). the study will comprise 3 steps: first, defining the most suitable method for matching the trus (transrectalultrasonography) to histology (step 1); second, refining the algorithms (training set); third, verification of the phs performances (test set). study objectives: * primary objective: * to evaluate the extent to which phs can discriminate between malignant lesions of the prostate versus non-malignant tissue in 3d rf trus data using radical prostatectomy histological step sectioning as the reference test. * secondary objectives: * to adapt and refine phs tissue characterisation algorithms using rf data that were previously developed using grey-level data as input. * to assess the accuracy of phs in predicting the volume of prostate cancers determined by histology. * to assess the ability of phs to rule in or rule out the presence of cancer \> or = 0.5 cc and of \> or = 0.2 cc as determined by histology. * to evaluate the ability to discriminate primary gleason pattern 4 and 5 versus 3 or less in tumours \> or = 0.5 cc and \> or = 0.2 cc. * to assess the ability of phs to correctly risk stratify patients.


Eligibility criteria:
inclusion criteria: * age: \>or=18 year-old * histologically (positive biopsy) proven prostate cancer with primary and secondary gleason patterns attributed. * patient planned to undergo radical prostatectomy * prostate cancer is deemed to be organ confined (t1-t2, nx or no, mx or mo) * no prior treatment for prostate cancer, including any type of hormonal therapy * no major calcification is noted during the trus (i.e. (diameter \>or=5 mm, spread all over the prostate or blocking to much of the ultrasound signal). * patient willing to give written informed consent exclusion criteria: * patients who are either unsuitable or unwilling to enter the study or to proceed to surgical investigation.
multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products

Conditions: Tobacco Dependence

Summary: multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. a study in healthy smokers.

fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. all products will be administered in accordance with labeling, on five separate treatment visits. the subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.

Eligibility criteria:
inclusion criteria: * healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion. * bmi between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. * willing and able to comply with all scheduled visits and study procedures exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication. * any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.

Keywords: smoking cessation nicotine pharmacokinetics
breaking through the brain fog: an online research study

Conditions: Breast Cancer Female

Summary: this study will investigate the benefits of distinct brain health trainings in breast cancer survivors (age 30-80) with cognitive concerns post-chemotherapy. this study can be completed from the comfort of participant's own home.

participants will complete online assessments at 3 timepoints over 6 months (month 0, 3, 6). during the first 3 months of the study, participants will be randomized into one of three online training programs to support cognitive function; training will end after the first 3 months. the third online assessment (month 6) will measure maintained gains since ending training. participants will not be aware of the interventions assigned to other participants. participants may be reimbursed for their time.

Eligibility criteria:
inclusion criteria: female breast cancer survivors who... * are between ages of 30-80 * were diagnosed with stage i-iii * received chemotherapy * completed chemotherapy at least 6 months ago but not more than 5 years * endorse changes in thinking since end of chemotherapy treatment * have working internet and a device * consider themselves fluent in english exclusion criteria: * males * a re-occurrence of breast cancer or a diagnosis of another * an uncorrected hearing or vision issue that would hinder ability to read and/or listen to training material * participation in a cognitive training program in the last 12 months. * a reported substance abuse problem * diagnosis of a neurodegenerative disease or psychotic disorder * history of stroke, concussion, or brain injury since completing chemotherapy * inability to function independently due to autism spectrum disorder diagnosis

Keywords: cognitive intervention
a study of ly2599666 in healthy participants and participants with mild cognitive impairment or alzheimer's disease (ad)

Conditions: Healthy; Alzheimer's Disease; Mild Cognitive Impairment

Summary: the main purpose of this study is to evaluate the safety and tolerability of the study drug known as ly2599666 in different groups of people - those who are healthy, those who have mild cognitive impairment due to alzheimer's disease (ad), and those with mild-to-moderate ad. the study will measure how much ly2599666 gets into the bloodstream and how long it takes the body to get rid of it. it will also evaluate how ly2599666 affects the body. the study has three parts. part a will last about 2 months. parts b and c will each last about 23 weeks. participants may only enroll in one part.


Eligibility criteria:
inclusion criteria: healthy participants part a: * overtly healthy males or females as determined by medical history and physical examination * have a body mass index (bmi) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive participants with mild cognitive impairment or alzheimer's disease (ad) \[part b and c\]: * participants are at least 50 years old at screening * present with mild cognitive impairment (mci) due to alzheimer's disease (ad) or mild-to-moderate ad * have a caregiver/study informant who provides a separate written informed consent to participate * have adequate vision and hearing for neuropsychological testing in the opinion of the investigator * positive florbetapir scan exclusion criteria: all participants * are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study * have known allergies to ly2599666, solanezumab, or any related compounds or components of the formulations, or have a history of significant atopy * have an abnormality in the 12-lead electrocardiogram (ecg) that, in the opinion of the investigator, increases the risks associated with participating in the study * have an abnormal blood pressure as determined by the investigator * have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisone * require treatment with other monoclonal antibodies participants with mild cognitive impairment or alzheimer's disease (ad) \[part b and c\] * have medical or surgical conditions in which lumbar puncture and or/catheter insertion is contraindicated * have any contraindication for magnetic resonance imaging (mri) studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with mri participants with mild cognitive impairment or alzheimer's disease (ad) \[part c\] * have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post treatment
vasopressin versus norepinephrine for the management of shock after cardiac surgery

Conditions: Shock

Summary: vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. the investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.


Eligibility criteria:
inclusion criteria: * need vasopressor support exclusion criteria: * younger than 18 years; * surgery without cardiopulmonary bypass; * emergency procedure; * ascending and descending thoracic aortic procedures; * left ventricular aneurysm resection; enrollment in another study; * pregnancy; * neoplasm; * raynaud's phenomenon, systemic sclerosis or vasospastic diathesis; * severe hyponatremia (na\<130meq/l); * acute mesenteric ischemia; * acute myocardial infarction; * cardiogenic shock; and refusal to consent

Keywords: shock norepinephrine vasopressin cardiac surgery
evaluation of the muscle strength and motor ability in children with spinal muscle atrophy(sma) treated with valproic acid

Conditions: Spinal Muscular Atrophy

Summary: the purpose of this study is to determine if the treatment with valproic acid can increase the muscle strength and motor ability of children with spinal muscular atrophy.

spinal muscular atrophy (sma) is an autosomal recessive disorder that affects the motoneurons of the spinal anterior corn, resulting in hypotonia and muscle weakness. the knowledge about its molecular mechanism has led to clinical tests with drugs that increase survival motor neuron (smn) protein level. the valproic acid (va) that acts as a histone deacetylase inhibitor activates the smn2 gene increasing the protein level. methods: twenty-two patients with type ii and iii sma, aged between 2 and 18 years old, were treated with va and were evaluated five times along a period of one year using the manual muscle test (medical research council scale-mrc), the hammersmith motor ability score, and the barthel index. the first evaluation was coincident with the introduction of va. results: after 12 months of therapy, the patients did not gain muscle strength but their motor ability has improved. children younger than 6 years of age had a higher pronounced gain in motor ability. conclusion: treatment of sma patients with va is one alternative to alleviate the progression of the disease.

Eligibility criteria:
inclusion criteria: * regularly attended at the out-patient service of neuromuscular disorders and child neurology of our institution; * more than 2 years olf and had a molecular analysis of spinal muscular atrophy; exclusion criteria: * had been submitted into a surgery recently; * did not come to the evaluation and medical sessions: * did not take the medication correctly

Keywords: spinal muscular atrophy valproic acid hmas mrc scale
stop-bang questionnaire: a predictor of obstructive sleep apnea and difficult mask/intubation?

Conditions: Difficult Intubation; Airway Disease

Summary: difficult airway management remains the leading cause of anaesthesia-related morbidity and mortality. obstructive sleep apnea syndrome (osas) is a warning sign of difficult airway management. polysomnography is the gold standard for diagnosis of this syndrome, but the stop-bang questionnaire is the preferred screening test. in this study, we wanted to find an answer to the question how successful is the stop-bang questionnaire in screening for obstructive sleep apnea syndrome (osas) in predicting osas, difficult mask and difficult intubation in patients undergoing thoracic surgery?


Eligibility criteria:
inclusion criteria: * patient undergoing thoracic surgery * 18-65 years old * asa 1-3 exclusion criteria: * having a history of obstructive sleep apnea syndrome, * having a history of previous head and neck surgery/radiotherapy, * patients who did not agree to participate in the study

Keywords: difficult intubation difficult mask obstructive sleep apnea syndrome stop-bang thoracic surgery
cmr in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 2; Heart Disease

Summary: the study will be performed as a cross-sectional survey. 300 type 2 diabetes patients (t2dm), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, slagelse hospital. the patients will undergo echocardiography, cardiac magnetic resonance imaging (cmr), clinical examination and will be asked to fill out questionnaires. this study project sets out to answer the following hypotheses: 1. patients with t2dm have an increased risk of developing diastolic dysfunction. using cmr, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. the investigators hypothesize that classic t2dm markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated hgba1c, t2dm duration, etc. are associated with pathological findings by cmr. 2. patients with t2dm have impaired left ventricle myocardial perfusion as determined by gadolinium contrast cmr. the investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast cmr.


Eligibility criteria:
inclusion criteria: * male or female patient fully capable of informed consent * informed consent * t2dm * age 18-80 (both years included) exclusion criteria: * contraindications to cmr (pacemakers/icd-units, cochlear implants) * lack of consent * atrial fibrillation * egfr \< 30 ml/min/1,73m2 (only exclusion criteria for gadolinium contrast study) * women of childbearing potential who are not on acceptable contraception * severe claustrophobia (only contraindication for cmr but can undergo echocardiography and other examinations) * contraindications to adenosine: history of significant bronchial asthma, 2nd or 3rd degree av-block, severe hypotension, long qt-syndrome, unstable angina pectoris, sinus node dysfunction, incompensated heart failure * contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis