Kornimate/medical-research-clean huggingface dataset:
volatiles in exhaled breath and blood in crohn's disease: validation cohort

Conditions: Crohn's Disease

Summary: this study evaluates the use of exhaled air analysis as tool to monitor the disease activity in crohn's disease (cd). this study is a validation of the previous findings. in this study the participant will be asked to donate exhaled air, blood samples and fecal samples. the breath samples will be used to measure various volatile metabolites in breath. the breath air will be next used to validate the previous findings. the blood samples will be used to define the origin of volatile metabolites in breath. finally, the potential of exhaled breath analysis as non-invasive marker of diseases activity will be compared to established fecal calprotectin.

in the recent study(doi: 10.1097/mib.0000000000000436) it was shown the potential of analysis of exhaled air to differentiate active and inactive state of crohn's disease (cd). although, the molecules found in this cohort have shown potential to differentiate between cd patients in remission or with active disease, the validation of the outcomes has to be performed in new population. one crucial pathophysiologic factor in cd is excessive lipid peroxidation during oxidative stress, i.e. during overproduction of oxidants compared to the protective antioxidants. oxidative stress is a potential aetiological factor and/or a triggering factor in cd. many volatile compounds including hydrocarbons and aldehydes are produced during oxidative stress and they can be non-invasively measured in exhaled air 5, 6. however, exhaled breath contains volatile metabolites originating from previous or current uptake of environmental contaminants, and more interestingly from metabolism of foreign organisms (bacteria, viruses, fungi or yeasts). therefore, it is important to study not only exhaled air but also blood in which blood borne volatile molecules can be measured. since the current study also aims for validating the use of volatile molecules in exhaled air as non-invasive markers for disease activity in cd patients, the investigators will compare the outcome of exhaled air analysis with currently established non-invasive measure of disease activity, i.e. fecal calprotectin.

Eligibility criteria:
inclusion criteria: * age: 18-65 * bmi: 19-30 * scheduled colonoscopy exclusion criteria: * disease compromising immune system (such as hiv positive status or patients after organ transplantation * liver disease * active and untreated tuberculosis * chemotherapy agents
eva: evista alendronate comparison

Conditions: Osteoporosis

Summary: the purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures


Eligibility criteria:
inclusion criteria * 50-80 years of age, inclusive * 2 years since last menses * dx femoral neck osteoporosis * no vertebral fractures exclusion criteria * poor candidate for study drugs * hx of diseases affecting bone metabolism * hx of breast/estrogen-dependent cancer * current use of osteoporosis drug therapy * hx/high risk of vte
cavatak (cva21) in non-muscle invasive bladder cancer (vla-012 canon)

Conditions: Non-muscle Invasive Bladder Cancer

Summary: the study consisted of 2 sequential parts. part a assessed the safety and tolerability of cavatak administered via intravesical instillation in patients with non-muscle invasive bladder cancer scheduled to undergo tur. part b assessed the safety and tolerability of cavatak administered in sequential combination with low dose mitomycin c in the same patient population.

this was a phase i, two-part, open-label, dose-escalation study designed to evaluate cva21 alone and in sequential combination with low-dose mitomycin c in patients with non-muscle invasive bladder cancer (nmibc) who were candidates for and were planning to undergo tur for treatment of their disease. this gave a relatively homogeneous study population and facilitated collection of resected tumour tissue for histological, pharmacodynamics (pd) and pharmacokinetic (pk) analyses.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of nmibc based on cystoscopic appearance * ecog 0-2 * no intravesical therapy within 6 weeks of study entry * no prior radiation to the pelvis * anc \>1500/mm³; hb \>9.0 g/dl; platelet \>100000/mm³ * serum creatinine ≤ 1.5 mg/dl * bilirubin within normal limits; ast ≤ 2.5x upper limit of normal (uln); alt ≤ 2.5 x uln; alkaline phosphatase ≤ 2.5x uln unless bone metastasis is present in the absence of liver metastasis * inr \< 1.2; appt = 0.8-1.2; pt = 0.9-1.8 * candidate for tur and planning to undergo tur * negative pregnancy test within 7 days of treatment start * patients of child-bearing potential must agree to use an effective method of birth control exclusion criteria: * prior local or systemic treatments for nmibc * concurrent treatment with any chemotherapeutic agent * patients not deemed acceptable for general anaesthesia * women who are pregnant or lactating * history of vesicoureteric reflux or an indwelling urinary stent * administration of an investigational agent within 3 months of study entry * active cardiac disease * known infection with hiv, hepatitis b or c * active uncontrolled infection

Keywords: coxsackievirus a21 bladder cancer cva21 cavatak
whole-body electrostimulation on functional mobility and quality of life in the elderly

Conditions: Aged

Summary: elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. a randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). whole-body electrical stimulation (wbs) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. the primary outcomes of this study are functional mobility (timed up and go test) and quality of life (eq-5d questionnaire). functional mobility will be assessed at baseline, after 4 and 8 weeks of treatment or follow-up. quality of life will be assessed only at the beginning and end of 8 weeks.

elderly people experience reduced strength, mass and muscle function throughout the aging process, and this negatively affects the functionality and quality of life of these individuals. rehabilitation strategies similar to conventional exercise that minimize the damage caused by aging and improve subjects' adherence need to be studied. a randomized clinical trial will be carried out with 30 volunteers who will be allocated into two groups (whole-body electrical stimulation or control). whole-body electrical stimulation (wbs) sessions will take place twice a week, for 8 weeks, totaling 16 sessions. simultaneously with the wbs, the elderly will perform exercises for the upper, lower limbs and trunk. the following assessments will be carried out at baseline and 8 weeks to verify the effect of therapy: assessment of functional mobility; quality of life (eq-5d); isometric muscle strength of the quadriceps muscles, biceps brachii and handgrip strength; lower limb muscle strength; assessment of body composition; assessment of cellular senescence; the inflammatory profile; well-being; measurement of muscle damage and pain; assessment of therapy safety and assessment of sleep quality. assessments of functional mobility, lower limb muscle strength, cellular senescence; the inflammatory profile; well-being; and muscle damage will also be carried out in 4 weeks.

Eligibility criteria:
inclusion criteria: * elderly people aged between 60 and 85 years; * both sexes; * to have the ability to walk. exclusion criteria: * cognitive dysfunction; * intolerance to electrical stimulator and/or changes in skin sensitivity; * skin injuries or burns where the electrodes are positioned; * sequelae of stroke; * recent acute myocardial infarction; * uncontrolled hypertension; * grade iv heart failure or decompensated; * unstable angina or arrhythmia; * peripheral vascular changes in the lower limbs such as venous thrombosis deep; * disabling osteoarticular or musculoskeletal disease; * uncontrolled diabetes; * cancer; * autoimmune disease; * pacemaker; * epilepsy; * hemophilia; * chronic obstructive pulmonary disease; * liver and kidney diseases; * grade ii obesity (bmi≥35).

Keywords: aged electric stimulation
dexmedetomidine,ketamine and their combination to bupivicaine on thoracic epidural analgesia

Conditions: Acute Pain

Summary: this study investigate the effect of addition dexmedetomidine, ketamine or their combination to bupivacaine in thoracic epidural analgesia on acute postoperative pain after breast cancer surgery.

breast cancer is the most common cancer diagnosed in egyptian women. many modalities are used in the treatment of breast cancer including chemotherapy, radiotherapy or surgical intervention. nowadays, surgical intervention is more conservative.modified radical mastectomy (mrm) is the standard surgical procedure of choice in these patients. mrm is usually performed under general anesthesia, almost always combining intravenous and inhalational agents.the drawback of general anesthesia includes inadequate pain control due to lack of analgesia, high incidence of nausea and vomiting, stress of anesthesia and surgery, and increasing the length of hospital stay.post mastectomy pain is a pain which occur following breast cancer procedures, particularly those operations that remove tissues in upper outer quadrant of breast and/or axilla. this pain can be severe enough to cause long term disabilities and interfere with sleep, performance of daily activities. also, it can seriously affect the patient mood, and social functions. thoracic epidural analgesia (tea) faces growing interest as adjuvant anesthetic and post-operative analgesic regimen. the use of adjuvant drug with local anesthetic is essential as it prolongs the duration of action, gives better success rate and increases patient satisfaction. ketamine, an n-methyl-d-aspartate (nmda) antagonist, not only abolishes peripheral afferent noxious stimulation, but it can also prevent the central sensitization of nociceptors. when added to epidural local anesthetics, ketamine appears to have adjuvant effects. dexmedetomedine is a selective, α2-adrenoceptor agonist with analgesic potency, sedative properties, and minimal respiratory depression when used as an adjuvant to regional anesthesia.

Eligibility criteria:
inclusion criteria: * patients scheduled for modified radical mastectomy. * asa physical status i, ii and iii. exclusion criteria: * patients' refusal. * uncooperative patients \& severe psychiatric illness (cannot evaluate their own pain intensity using visual analogue scale (vas). * patients with history of drug allergy. * severe renal or liver impairment, unstable ischemic heart disease * any contraindications to epidural analgesia (coagulopathy, recent -less than 1 week-treatment with thrombolytic or potent antiplatelet drugs as clopidogrel, and local infection).

Keywords: postmastectomy pain
benign paroxysmal positional vertigo (bppv) in nursing homes: treatment efficacy and impact on balance, gait and falls

Conditions: BPPV

Summary: bppv is a benign condition of the balance organ, localized in the inner ear, in which calcium crystals loosen up and move freely in the endolymphatic fluid of the inner ear (more specifically in the semi-circular canals). during certain posture changes or head movements, these moving calcium crystals cause dizziness and balance problems. the general objective of the study is to evaluate the impact of bppv on the balance of older adults in nursing homes. for this purpose, we will compare the balance of residents with bppv with residents without bppv. furthermore, we will identify the impact of treatment on balance problems and fall risk in older adults in nursing homes.


Eligibility criteria:
inclusion criteria: * institutionalized for at least 3 months * willing to participate * able to understand simple instructions * able to stand independently for 10 seconds (with the use of a walking aid) exclusion criteria: * diagnosis of progressive neurological conditions resulting in a fast deterioration (i.e. amyotrophic lateral sclerosis or residents with palliative care) * participation in a rehabilitation program at the current time for a pathology of less than 6 months * contra-indication for vestibular testing such as heart failure or fear

Keywords: benign paroxysmal positional vertigo vertigo older adults frailty nursing home
optimising visual acuity measurement in macular degeneration

Conditions: Age Related Macular Degeneration

Summary: age-related macular degeneration (amd) is the leading cause of visual impairment in the uk. the condition is characterised by damage to the region of the retina (macula) responsible for detailed central vision, this leading to problems with tasks such as reading and face-recognition. the ability to accurately measure vision is central to the detection and management of amd. the most common test (visual acuity) typically requires patients to identify black letters of varying size on a white background, with the smallest letter read representing the limit of vision. conventional tests are however known to be variable, making it difficult to determine if a true change in vision has occurred. previous work has found the moorfields acuity chart, which contains specially constructed letters composed of a black core and white border, to be more sensitive to early amd compared to standard charts. despite this advantage, it is unclear if there is an associated increase in measurement variability with the moorfields acuity chart and if this changes with the severity of disease. in this study, the relationship between vision test sensitivity and measurement variability will be quantified with both conventional visual acuity tests and the new moorfields acuity chart to identify the optimal vision test to detect and monitor amd in the clinic.


Eligibility criteria:
group 2 - healthy control participants: inclusion criteria will include: * absence of ocular disease in either eye * male or female, aged 18 years or older * the absence of significant media opacities * ability to understand nature/purpose of the study and to provide informed consent * ability to follow instructions and complete the study * ability to speak english exclusion criteria will include: * any systemic disease likely to affect visual performance * presence of any ocular disease * hearing impairment sufficient to interfere with hearing instructions * poor understanding of english language and/or alphabet * any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
uveitis gene-expression profiling

Conditions: Uveitis

Summary: uveitis is a group of troublesome diseases that collectively represent a cause of blindness comparable to diabetes. most forms of uveitis are either infectious or immune-mediated. the investigators propose to create a data base on peripheral blood gene expression for patients with 3 of the most important diseases associated with uveitis: ankylosing spondylitis, sarcoidosis, and behcet's disease. the investigators will quantitatively measure the expression of consistent alteration in peripheral blood from patients with more than 40,000 gene sequences using microarray gene chip technology. this approach is known to detect systemic immune-mediated disease. the investigators will use this data base to: 1. determine if patients with uveitis and ankylosing spondylitis, sarcoidosis, or behcet's can be distinguished from a normal population or controls with the same systemic disease but no history of uveitis 2. determine if the profile of gene expression can distinguish infectious or idiopathic forms of uveitis from patients with spondylitis, sarcoidosis, or behcet's 3. determine how this gene profile changes over time as episodic disease such as spondylitis or behcet's activates or remits 4. correlate the changes in gene expression with the prognosis of the ocular inflammatory process. the creation of a gene expression data base for patients with uveitis has the potential to clarify the pathogenesis of disease, establish new diagnostic tools, and provide a means for predicting prognosis.


Eligibility criteria:
inclusion criteria: * the study group will include patients aged 21 years or older attending the uveitis clinic at the casey eye institute at ohsu who have uveitis of the following subtypes: 1. ankylosing spondylitis 2. sarcoidosis 3. behçet's disease 4. toxoplasmosis 5. herpetic acute retinal necrosis; and 6. idiopathic uveitis * another group of patients, also aged 21 years or more, with the following diseases but no uveitis, will be recruited from the rheumatology clinic at ohsu as follows: 1. ankylosing spondylitis 2. sarcoidosis; and 3. behçet's disease * the study group will also include 30 normal control volunteers aged 21 years or older. exclusion criteria: * special/vulnerable subject populations (e.g., mentally impaired persons and children) will not be enrolled.
prf in management of chronic multiple oral ulcers

Conditions: Oral Ulcer Due to Pemphius Vularis; Oral Ulcer Due to Benign Mucous Membrane Pemphioid; Oral Ulcer Due to Steven Johnson's Syndrome

Summary: prf in orabase will be applied as a pack material on chronic oral ulcers of chronic multiple oral lesions compared to conventional topical steroid therapy with clobetasol propionate 0.05% in orabase. the outcomes measured are pain alleviation as primary outcome and clinical improvement in terms of ulcer size, number and mucositis score as secondary outcomes. time frame for outcomes assessment will be daily for 7 days regarding pain score and weekly for 2 weeks regarding clinical improvement.

the management of oral ulcers and mucositis specially the resistant types such as oral ulcers due to auto-immune diseases is a major concern by the dentists through all the world. topical corticosteroids, analgesics, laser bio modulation all have been proposed as treatments with limited efficacy in many cases. there are few number of clinical trials on plasma preparation in management of oral mucositis and oral ulcers. platelet rich fibrin (prf) is one of the platelet concentrates. the preparation protocol of prf is simple and easy, could be prepared autologous and immediately placed on the oral ulcers and mucositis. subjects and methods: a non randomized clinical trial will be conducted. ten patients with different resistant oral ulcers and mucositis were enrolled. all with grade 4 who mucositis score. the initial numerical ratting score of pain is 10. for all patients 20 ml blood sample will obtained in plain blood vacutainer, centrifuged for 15 minutes on 3000 rpm. the resultant gel, obtained and squeezed to prepare a membrane, the membrane will be mixed with orabase and placed over the oral ulcers and mucositis over a piece of gauze. the patients will be instructed not to eat or drink for 2 hours after application. the remaining serum after squeezing was mixed with equal amount of orabase and used topically on the oral mucositis and ulcers. clobetasol propionate 0.05% in orabase will be applied to 10 control patients 3 times per day for one week. the steps will be repeated after one week if the patients' symptomatic scores for who and numerical rating score were not zero.

Eligibility criteria:
inclusion criteria: * patients with oral ulcers due to benin mucous membrane pemphioid, pemphius vulgaris and steven johnson's syndrome with mucositis score 4 and pain score 10 exclusion criteria: * patients with any systemic other systemic condition

Keywords: platelet rich fibrin, oral ulcer, pain, mucositis
an open-label comparison of duloxetine to other alternatives for the management of diabetic peripheral neuropathic pain

Conditions: Diabetic Neuropathy, Painful

Summary: to test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin.


Eligibility criteria:
inclusion criteria: * you must have been diagnosed with diabetic neuropathic pain * patient has an average daily pain score greater than or equal to 4 on an 11-point likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted * patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report * patient must agree not to change dose of gabapentin between visits 1 and 2 * you must have stable glycemic control exclusion criteria: * are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the beck depression inventory-ii (bdi-ii) * current diagnosis or history of hemangiosarcoma * patients with new york heart association class iii or iv symptoms of congestive heart failure * patients with uncontrolled narrow-angle glaucoma * presence of a current seizure disorder