Kornimate/medical-research-clean huggingface dataset:
xenox - evaluation of the efficacy of xaliproden in reducing the neurotoxicity of the oxaliplatin + 5-fu/lv chemotherapy

Conditions: Metastases; Colorectal Neoplasms; Colorectal Carcinoma

Summary: purpose of the trial is to evaluate the efficacy of xaliproden in reducing the neurotoxicity of the oxaliplatin and 5-fu/lv chemotherapy, in patients with metastatic colorectal carcinomaprimary objectives : compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of oxaliplatin between treatment group and placebo group ; compare the response rate between treatment group and placebo group.secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven adenocarcinoma of the colon or the rectum * age \> 18 years * who performance status : 0,1,2 * signed written informed consent prior to study entry * disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease) * measurable disease * no prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months) * prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study exclusion criteria: * chemotherapeutic agents other than 5-fu/lv or 5-fu/levamizole as part of adjuvant therapy * prior therapy with oxaliplatin * history of cardiac toxicities under 5-fu/lv therapy or myocardial infarction within the 6 months before study entry ; known dihydropyrimidine dehydrogenase deficiency * history of intolerance to appropriate antiemetics * concurrent active cancer originating from a primary site other than colon or rectum * presence of any symptom suggesting brain metastasis * known peripheral neuropathy * interstitial pneumonia or extensive and symptomatic fibrosis of the lung * allergy to xaliproden/excipients

Keywords: neurotoxicity syndromes paresthesia oxaliplatin xaliproden
determining the relationship between the atherosclerosis and periodontopathogenic microorganisms

Conditions: Atherosclerosis; Chronic Periodontitis

Summary: determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.

it has been aimed in this study to compare 1) the change in periodontal status; 2) the change of the periodontopathogen microorganisms (a. actinomycetemcomitans, p. gingivalis, t. forsythia, t. denticola, p. intermedia, p. micros, f. nucleatum/periodonticum, c. rectus, e. nodatum, e. corrodens, and c. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the changes of the amounts of hdl, ldl, hs-crp white blood cell levels (wbc), platelet levels (plt), creatinine, and fibrinogen in serum samples; and 4) the correlation between periodontopathogen microorganisms (a. actinomycetemcomitans, p. gingivalis, t. forsythia, t. denticola, p. intermedia, p. micros, f. nucleatum/periodonticum, c. rectus, e. nodatum, e. corrodens, and c. gingivalis/ochracea/sputigena) and hdl, ldl, hs-crp wbc, plt, creatinine, and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic periodontitis and systemic healthy patients and patients diagnosed with chronic periodontitis, following non surgical periodontal treatment.

Eligibility criteria:
inclusion criteria: * had no systemic disease, * had not used any antibiotics * had not used medications with an impact on the immune system, * had not received any periodontal and/or medical treatment within the last 6 months. exclusion criteria: * smokers of cigarettes or other tobacco products, * pregnant or breastfeeding, * non-stable cardiovascular condition.

Keywords: periodontopathogenic microorganisms non-surgical periodontal treatment
employment and arthritis: making it work

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Lupus Erythematosus, Systemic; Psoriatic Arthritis; Other Connective Tissue Diseases; Spondylarthropathy

Summary: the investigators plan to conduct a randomized controlled trial to evaluate the effectiveness and the cost effectiveness of an on-line elearning program (entitled employment and arthritis: making it work) designed to help people with inflammatory arthritis stay employed. the program also includes assessments with 1) an occupational therapist, and 2) a vocational rehabilitation counsellor at the end of the program to help participants identify and obtain necessary changes at work. people from three provinces will be recruited from collaborators' patient and program recipient lists. the study group will receive the program intervention and the control group will receive "usual care" and printed educational material. all participants will be followed for five years. the effectiveness of the program at improving at work productivity and reducing work cessation will be evaluated compared to a control group receiving printed material on employment and arthritis.


Eligibility criteria:
inclusion criteria: * between ages 18 and 59 years * able to read and write english * have inflammatory arthritis confirmed by a rheumatologist (rheumatoid arthritis, ankylosing spondylitis, lupus erythematosus, systemic, psoriatic arthritis, other connective tissue diseases and spondylarthropathy) * have access to a computer, a web-cam, a headset and a printer, or willingness to purchase these items * are willing to travel to vancouver, kelowna, victoria, prince rupert, prince george, cranbrook or kamloops, calgary, toronto, newmarket or brampton for one visit with an occupational therapist exclusion criteria: * individuals who are not working * individuals on sick leave, short term or long term work disability * students * people performing unpaid work such as volunteer work or taking care of family * people planning to retire in the next six years * individuals unable to provide informed consent * individuals living outside of british columbia, alberta, ontario
evaluation of jejunal placement of enteral feeding tubes

Conditions: Critical Illness; Tube Feeding

Summary: the purpose of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative icu patient population. the investigators hypothesized that success rate of the electromagnetic jejunal tube placement will be lower than the success rate of the endoscopic method.

clinical studies have shown that up to 62,8% of patients receiving en have gastrointestinal complications like high gastric residuals (≥200ml), vomiting, abdominal distension and regurgitation. these complications lead to interruptions of the en, which result in a low caloric intake of the patient. in order to avoid at least some of these complications the accp consensus statement recommends small bowel feeding if gastric residual volumes of 150ml or higher occur. the canadian clinical practice guidelines recommend acceptance of gastric residual volumes up to 250 ml, use of prokinetic agents and jejunal feeding for patients, who are at high risk for intolerance of en (on inotropes, sedatives, paralytic agents). when gastric enteral nutrition is insufficient despite acceptance of high gastric residual volumes and use of prokinetic agents, small bowel feeding is the best method to nevertheless feed the patient enterally because it is associated with a significant decrease of reflux, a reduced risk of aspiration and an adequate caloric intake. for small bowel feeding the placement of a jejunal feeding tube is necessary. there are several possibilities to place the tube in the small bowel. an excellent method still is endoscopy, which has a success rate up to 98% and moreover allows an evaluation of the upper gi-tract concerning pathologies. however, it is a rather time consuming procedure, which is of limited availability and requires trained staff. as more simple alternatives unguided tubes and their placement in the small bowel were tested and showed success rates up to 75% only. one of these alternatives is a jejunal feeding tube, which is placed using an electromagnetic sensing technique to visualize the placement process on a bedside monitor (cortrak™). the aim of this study is the evaluation of the success rate of jejunal tube placement comparing the endoscopic versus the electromagnetic method in a comparative icu patient population.

Eligibility criteria:
inclusion criteria: * intolerance of intragastric feeding (high gastric residual volumes (≥250ml)and/or repeated vomiting) * clinical indication of jejunal feeding exclusion criteria: * patients not fulfilling clinical indication of jejunal feeding or contraindications for jejunal feeding

Keywords: critical illness enteral nutrition gastrointestinal intubation
rare tumours in children and adolescents (step)

Conditions: Rare Diseases

Summary: the aim of the step registry is to collect and evaluate experience and data on the diagnosis and treatment of rare childhood tumors in order to use the knowledge gained to improve the treatment prospects for our patients. the rarity of a disease should not be a disadvantage for the young patients.

the objective of the step registry is to optimise the diagnosis and treatment of patients with rare tumour diseases in childhood and adolescence. therefore, a continuous prospective collection of clinical data on rare paediatric tumours is conducted to improve the understanding of these tumours. beyond analysis of clinical data, further scientific research on the biological and molecular genetic characteristics of these tumours is performed. these data and a close collaboration with international partners, especially the european expert group, enable the improvement of treatment recommendations for these tumours along with establishment a global interdisciplinary network of rare tumour specialists.

Eligibility criteria:
inclusion criteria: * diagnosis of a rare solid tumor * age at diagnosis: neonatal period to 18 years (in the case of young adults, registration in the database and/or referral to advisory contact persons within the framework of the competence network can take place upon request and after declaration of consent.) * information, education, written consent of the patient or the guardian * not recorded in any of the existing clinical studies/ registers of the german society for pediatric oncology and hematology (gpoh) exclusion criteria: * registration of the tumor diagnosis in a prospective therapy study/ another clinical registry of the gpoh * lack of information, explanation and/or written consent of the patient or the legal guardian.

Keywords: epidemiological data collection rare tumors in children rare tumors in adolescents clinical data collection
ex-vivo investigation of beta probe for prostate cancer resection and evaluation of psma-pet for diagnosis of intraprostatic lesions

Conditions: Prostate Cancer

Summary: 68ga-psma is a radiopharmaceutical used with pet imaging for the detection of prostate cancer under a compassionate ind in patients who have presented with biochemical failure. in this study, the use of 68ga-psma-11 will be extended to newly diagnosed patients with high risk prostate cancer. patients enrolled to this study will undergo a 68ga-psma-11 pet/ct or pet/mri scan for research purposes (in addition to the routine ct or mri that is routinely done for staging), and a second 68ga-psma-11 administration just prior to surgery for experimental ex-vivo beta probe testing of resected tissue. immediately following resection of the prostate, the intact tissue will be scanned using a pet camera designed for animal research in order to record the 68ga-psma-11 distribution in the isolated tissue at higher resolution than can be attained using whole-body pet imaging. the experimental beta probe will then be use to measure 68ga-psma-11 counts of the resected tissue.

primary objective to assess beta ray detection of prostate cancer ex-vivo using experimental beta probe immediately after prostate cancer removal as determined by pathologist. secondary objectives * compare preoperative standard of care staging via ct or mri to 68ga-psma-11 pet (ct or mri) findings. * compare preoperative 68ga-psma-11 pet (ct or mri) lesion measurements with postoperative high-resolution pet of ex-vivo tissue. * to compare the findings of each of the 68ga-psma-11 detection methods to the surgical observations and the clinical tissue histopathology findings. exploratory objective correlation of beta probe measurements with preoperative 68ga-psma-11 pet (ct or mri) lesion measurements, postoperative pet/ct ex-vivo images, surgical observations, and pathology findings.

Eligibility criteria:
inclusion criteria to be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below: 1. ≥ 18 years of age 2. must provide written informed consent 3. presence of high grade prostate cancer (gleason grade group 1-5) on prostate biopsy or prostate cancer recurrence. 4. scheduled for prostate cancer removal 5. willing and able to lie still for approximately 30 minutes in an enclosed space for the 68ga-psma-11 pet ct or mri exclusion criteria 1. participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days. 2. significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Keywords: surgical resection margins of resection beta radiopharmaceutical beta probe device ex-vivo
topical acetaminophen for itch relief: a proof of concept study in healthy subjects

Conditions: Pruritus

Summary: currently, topical antihistamines and corticosteroids are mainly used for itching relief. however, the over the counter antihistamines are not effective on all itch conditions. acetaminophen is a popular and widely used otc drug for pain relief. although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid cb1 receptors. recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.

this will be a single-blinded, vehicle-controlled randomized study in healthy controls to test the efficacy of the topical gel formulation with three differing concentrations of acetaminophen (apap) for itch relief. to detect medium effects of the treatments with a given α of 0.5 and an error probability of 0.05, with a power of 0.95, the number of participants needed is 36 (10 within post hoc pairwise comparisons).

Eligibility criteria:
inclusion criteria: 1. healthy subjects must be between 18 and 50 years of age. 2. must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception. 3. no history of chronic itch or pain. 4. must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study. 5. must abstain from the use of moisturizers on the arms 24 hours before study visits. exclusion criteria: 1. individuals under 18 or over 50 years of age. 2. inability to complete the required measures. 3. the presence of an itchy skin disease. 4. diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies). 5. currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy. 6. use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.). 7. use of emollients on the arms a week prior to the study and throughout the study. 8. known allergies to acetaminophen and cowhage. 9. pregnant women. (women of child bearing potential will undergo an hcg pregnancy test). 10. currently incarcerated.
effect of dry needling on spasticity in stroke survivors.

Conditions: Spastic Hemiplegia

Summary: stroke is a disruption of blood flow to brain either due to clot formation or rupturing of arteries.it is a leading cause of disability worldwide with many consequences and spasticity is one of them.spasticity is a resistance to passive stretch which disturbs patient quality of life and interrupt activity of daily living.there are multiple options to treat spasticity which includes both pharmacological and non-pharmacological treatments.

stroke is a global issue and burden of disease is high in asia.the burden of disease is alarming due to its consequences and spasticity is one of them.according to the lance definition clinical practice is still based which is too narrow. spasticity, according to lance, is a motor disease characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with excessive tendon jerks, due to hyper excitability stretch reflex.furthermore, long-term untreated spasticity can cause discomfort, contractures, and deformities, which can lead to functional issues such as mobility limitations, reliance on (adl), and a lower quality of life.there is multiple option to treat spasticity including pharmacological and rehabilitation pharmacological treatments that can be focal or systematic and have partial effects and eventually need of physical therapy there are many pt procedures which includes stretching neurodevelopment techniques and many others to prevent spasticity.

Eligibility criteria:
inclusion criteria: - 1: ischemic or hemorrhagic stroke and includes any of the artery 2: hemiplegia 3: chronic stroke (stroke at least 6 months before the trial) 4: present a level of spasticity equal or greater than between 1 to 3 according to modified ashworth scale. 5: preserve cognitive capacity according to 6 cognitive items test (6cit), montreal cognitive assessment (moca) and mini mental state examination (mmse) exclusion criteria: 1: insurmountable fear of needles. 2: wrist fracture. 3: have received previous treatment with dry needling. 4: have progressive or severe neurological disease. -

Keywords: dry needling modified ashworth scale goniometer range of motion
safety and cognitive function study of evp-6124 in patients with schizophrenia

Conditions: Schizophrenia; Central Nervous System Diseases; Cognition

Summary: this study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, evp-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. in addition, behavioral and psychotic symptoms will be evaluated.

this is a randomized, double-blind, placebo-controlled, phase 2 safety/efficacy study in which two dose levels of evp-6124 will be evaluated. eligible for enrollment will be patients who meet clinical criteria for schizophrenia and who are taking chronic atypical anti-psychotic medication at a stable dose. this study will therefore evaluate the effects of evp-6124 when administered concomitantly with anti-psychotic medication. patients will be randomized to one of the following groups: 0.3 mg or 1.0 mg evp-6124, or placebo. seventy-five patients per group. study drug will be supplied as capsules and will be orally administered once daily for a total of 84 days.

Eligibility criteria:
inclusion criteria: * subjects who meet clinical criteria for schizophrenia or schizo-affective disorder utilizing the structured clinical interview (sci) * must be treated with a second generation anti-psychotic drug other than clozapine at a stable dose for at least 4 weeks and must have been on that drug and clinically stable for at least 8 weeks * must have no more than "moderate" severity rating for negative symptoms: bprs item ≤4 * a minimal level of extrapyramidal symptoms (eps); simpson-angus scale total score ≤6 * a minimal level of depression; calgary depression scale total score ≤10 * must have a general health status acceptable for participation in a 12-week clinical trial * fluency (oral and written) in the language in which the standardized tests will be administered * if a smoker, the ability to refrain from smoking for at least 30 minutes prior to any cognitive testing exclusion criteria: general * insufficiently controlled diabetes mellitus in the judgment of the investigator * malignant tumor within the last 5 years with the exception of squamous and basal cell carcinoma or cervical carcinoma it situ * pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study * unstable medical condition that is clinically significant in the judgment of the investigator: major organ system dysfunction

Keywords: schizophrenia central nervous system diseases cognition
comparison of somofilcon a daily disposable test contact lens and somofilcon a daily disposable control contact lens

Conditions: Myopia

Summary: the purpose of this study is to investigate the overall clinical performance of the somofilcon a daily disposable test soft contact lens compared to the somofilcon a daily disposable control soft contact lens.

the purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Eligibility criteria:
inclusion criteria: * is at least 17 years of age and has full legal capacity to volunteer; * has had a self-reported oculo-visual examination in the last two years; * has read, understood, and signed the information consent letter; * is willing and able to follow instructions and maintain the appointment schedule; * has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity); * must be able to achieve 20/30 or better (in each eye) with the study lenses; * currently wears soft contact lenses for at least 3 days per week, 8 hours each day; * requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25d steps); * has no more than 0.75 diopters of refractive astigmatism; * has clear corneas and no active\* ocular disease; * has not worn lenses for at least 12 hours before the examination. exclusion criteria: * is presently participating in any other clinical or research study including eye related clinical or research study; * has never worn contact lenses before. * has any systemic disease affecting ocular health. * has any active\* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health. * has any known sensitivity to fluorescein dye or products to be used in the study. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).