Kornimate/medical-research-clean huggingface dataset:
trial evaluating the efficacy of the combination of ropivacaine with reference xylocaine in the evaluation of pain during the installation of percutaneous radiological gastrostomy

Conditions: Cancer; Feeding Disorders

Summary: gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. however, there is no clear recommendation about local analgesia during this exam. operator can chose lidocaine with a short period of action, or ropivacaine with a longer period of action. the association of these two drugs could enhance the analgesia post procedure. the main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.

gastrostomy is an intra-gastric nutritional enteral device, allowing the nutritional support for patients presenting oral feeding disorders. gastrostomy could be put in place by different manners: * chirurgical technique or endoscopy: with general anesthesia; * percutaneous technique under radiological guidance: allowing local anesthesia. this last one is better tolerated by weak patients, and involves less complication. however, there is no clear recommendation about local analgesia during this exam. operator can chose lidocaine with a short period of action, or ropivacaine with a longer period of action. the association of these two drugs could enhance the analgesia post procedure. indeed, pain felt during the twenty four hours post procedure seems to be the most frequent adverse effect reported by patients. pain could decrease significantly when ropivacaine is added to the reference xylocaine. ropivacaine had already proved its efficacy in association with other antalgics. the main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.

Eligibility criteria:
inclusion criteria : * major patient; * having an indication for placement of prg (percutaneous radiological gastrostomy); * patient hospitalized for a minimum of 24 hours post gastrostomy; non-inclusion criteria : * pregnant or lactating woman; * legal incapacity or limited legal capacity. medical or psychological conditions which do not allow the subject to understand the study and sign the consent (art. l.1121-6, l.1121-7, l.1211-8, l.1211-9); * not knowing how to read and / or write french; * allergy and / or known hypersensitivity to lidocaine and / or ropivacaine or to other local anesthetics with amide bond or to one of the excipients; * recurrent porphyrias (genetic, hereditary diseases affecting the production of hemoglobin); * patient on beta blockers during the installation of prg (percutaneous radiological gastrostomy); * indication of gastrostomy button placement.

Keywords: cancer gastrostomy percutaneous technique radiological guidance lidocaine ropivacaine pain
no power bionic lower extremity prosthesis

Conditions: Amputation; Amputation, Traumatic; Amputation; Traumatic, Leg, Lower

Summary: typically people need separate prosthetic feet for running and walking. to bridge the gap, this study will test the compliant adaptive energy storage and return (caesar) foot. this foot can change from a walk mode to a run mode with the push of a button. the investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. the goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.

typically people need separate prosthetic feet for running and walking. to bridge the gap, this study will test the compliant adaptive energy storage and return (caesar) foot. this foot can change from a walk mode to a run mode with the push of a button. the investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. the goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active. here we will test this device to determine how it affects the user's mechanics during running and walking. participants will come to a research laboratory for three test sessions where they will run and walk in their current foot, a commercial high-activity foot, and the prototype caesar foot.

Eligibility criteria:
patient population: inclusion criteria: * at least 18 years old * transtibial amputation of one or both legs * classified as k3 or k4 on the medicare functional classification level * use of a well-fitting prosthetic socket and prosthetic foot for at least 6 months * able to walk and run without assistance exclusion criteria: * significant injury to intact limb * history of balance impairments or neurologic disorders * significant cardiovascular or respiratory disease
fit for function: a community wellness program for persons with stroke

Conditions: Cerebrovascular Accident

Summary: building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community ymca-based wellness program specifically designed for people with stroke (fit for function) to a standard ymca membership.

the program will be delivered through a partnership between mcmaster university, the ymca and hamilton health sciences/ the brant community healthcare system/ the niagara health system. participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. the ymca staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. the hospital within each region will provide specialized on-site physiotherapy consultative support. the comparator standard ymca membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.

Eligibility criteria:
inclusion criteria: * diagnosed with stroke * 18 years of age or older * community dwelling * able to walk 10m independently, with or without an assistive device * medically approved by a physician to participate * able to tolerate 60 minutes of activity with rest intervals * able to independently follow instructions exclusion criteria: * involved in an active rehabilitation program

Keywords: community program wellness exercise physical activity education stroke self-management
evaluating the incidence of pseudo-acute kidney injuries in patients with metastatic breast cancer on cdk4/6 inhibitors trough cystatin c analysis

Conditions: Advanced Breast Cancer

Summary: cdk4/6 inhibitors have led to an improvement of both progression free survival (pfs) and overall survival (os) in patients with advanced estrogen positive (er+)/her2- breast cancer when applied in the first or second line of treatment. despite the advantages of cdk4/6 inhibitors, these medications can lead to adverse effects. one of the adverse events observed across all types of cdk4/6 inhibitors is an elevation in creatinine levels. an elevation in plasma creatinine during treatment with abemaciclib is not always indicative of a reduction in renal function; it can also be attributed to the inhibition of active tubular secretion of creatinine. this phenomenon is known as pseudo acute kidney injury (pseudo-aki). the incidence of pseudo-aki in patients using cdk4/6 inhibitors is currently unknown. a method to distinguish pseudo-aki from aki is measuring the level of an alternative filtration marker in blood, for example cystatin c. cystatin c is also filtered at the glomerulus but not secreted intro the renal tubulus or reabsorbed into the bloodstream. also, there is no affection by muscle mass or diet. in this study the investigators will explore the incidence of both aki and pseudo-aki in patients who are treated with cdk4/6 inhibitor treatment by assessing both creatinine and cystatin c in plasma.


Eligibility criteria:
inclusion criteria: * adult patients who are receiving cdk4/6 inhibitors for metastatic breast cancer * patients must have used the cdk4/6 inhibitor for a minimum duration of one month * patients must have undergone at least one measurement of creatinine after the initiation of cdk4/6 inhibitor treatment exclusion criteria: - patients who are undergoing dialysis therapy for kidney failure.
a re-licensing study to assess the efficacy of inflexal v formulated with who recommended 2010/2011 influenza virus strains for the northern hemisphere

Conditions: Influenza

Summary: a study to assess whether the northern hemisphere 2010/2011 season influenza vaccine inflexal v fulfills the emea requirements for re-registration of influenza vaccines


Eligibility criteria:
inclusion criteria: * healthy female and male adults * aged ≥18 to ≤60 years or \>60 years on day 1 * written informed consent exclusion criteria: * acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease * acute febrile illness (≥38.0 °c) * prior vaccination with an influenza vaccine in the past 330 days * known hypersensitivity to any vaccine component * previous history of a serious adverse reaction to influenza vaccine * history of egg protein allergy or severe atopy * known blood coagulation disorder * chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) * known immunodeficiency (incl. leukemia, cancer, hiv seropositivity) * investigational medicinal product received in the past 3 months (90 days) * treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days) * pregnancy or lactation * participation in another clinical trial * employee at the investigational site, or relative or spouse of the investigator * suspected non-compliance

Keywords: influenza virus vaccination immunisation
a dose-escalation study of gdc-0994 in patients with locally advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: this is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of gdc-0994 in patients with locally advanced or metastatic solid tumors. patients will be enrolled in one of two stages: a dose-escalation stage (stage i) or the subsequent expansion stage (stage ii). stage i will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of gdc-0994 administered daily. stage ii will gather additional data on safety, tolerability, and pharmacokinetics of the recommended dose of gdc-0994 determined in stage i.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable * evaluable disease or disease measurable per recist 1.1 * life expectancy \>= 12 weeks * adequate hematologic and end organ function * consent to provide archival tissue exclusion criteria: * history of prior significant toxicity from another mek or erk inhibitor requiring discontinuation of treatment * history of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months * evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment * history of glaucoma * intraocular pressure \> 21 mmhg as measured by tonometry * predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy * history of retinal vein occlusion (rvo), neurosensory retinal detachment, or neovascular macular degeneration * allergy or hypersensitivity to components of the gdc-0994 formulation * palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in cycle 1 * experimental therapy within 4 weeks prior to first dose of study drug treatment in cycle 1 * major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in cycle 1, or anticipation of the need for major surgery during the course of study treatment * prior anti-cancer therapy within 28 days or 5 times the half-life whichever is longer * current severe, uncontrolled systemic disease * history of clinically significant cardiac dysfunction * pregnancy, lactation, or breastfeeding * active autoimmune disease * inability or unwillingness to swallow pills * known brain metastases that are untreated, symptomatic, or require therapy to control symptoms * clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with hiv, hepatitis b virus, or hepatitis c virus * any condition requiring warfarin or thrombolytic anticoagulants * uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
evaluation of the effect of pomegranate peel added bread on blood sugar, fats, and the body's defense response

Conditions: Type 2 Diabetes

Summary: the aim of this study is to evaluate the effects of the consumption of bread produced with the addition of pomegranate peels, which has a high antioxidant content, on blood glucose and lipid parameters, and some oxidant-antioxidant enzymes and lipid peroxidation in individuals with type 2 diabetes.

between 01.02.2022 and 30.05.2022 with specialist dr. emel senol's approval, by specialist dr. akkız zuhal öztaş the study will be conducted with 30 volunteers who present to the city hospital internal medicine polyclinic in mersin.

Eligibility criteria:
inclusion criteria: * being diagnosed with type 2 diabetes for at least 5 years, * using only oral antidiabetic * with a body mass index (bmi) value ≥ 25.0 kg/m2, * signing the informed voluntary consent form, * being in an age range of 19-64 years. exclusion criteria: * having kidney, liver, and inflammatory diseases, * being on insulin therapy, * using prescription drugs and/or fiber supplements, * taking vitamin and mineral supplements, * being pregnant/lactating, * consuming excessive alcohol (\>2 drinks/day), * being in the menstrual period, * receiving gluten enteropathy, * having allergy against pomegranate. * in addition, individuals with covid-19-related condition during the study process will be excluded from the study.

Keywords: antioxidant obesity pomegranate peel oxidation type 2 diabetes
diffusion imaging in acute auto-immune encephalitis

Conditions: Auto-immune Encephalitis

Summary: the aim of this non randomised retrospective study is to investigate the imaging (mri) of auto-immune encephalitis at presentation, especially in diffusion-weighted sequences. indeed, few series describe the mri aspect of auto-immune at their beginning. recognize early mri abnormalities seen in auto-immune encephalitis could help reduce the time to positive diagnosis and improve the therapeutic management.


Eligibility criteria:
inclusion criteria: * auto-immune encephalitis proved by biological results (blood and/or csf sample) exclusion criteria: * no mri available

Keywords: mri
misoprostol for nash

Conditions: NASH

Summary: the aim of this randomised control trial is to evaluate the effect of misoprostol in treating patients with nash.


Eligibility criteria:
inclusion criteria: 1. patients between age 25 and 64 years 2. patients having nafld as evident by a radiologic test like ultrasound/fibroscan/ct scan etc. 3. alt level of 1.5 times uln 4. if already known case of nafld, then patient should be on stable doses of vitamin e, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment. exclusion criteria: 1. patients with age less than 18 yrs or more than 80 yrs, 2. women of childbearing age 3. clinically significant acute or chronic liver disease unrelated to nafld 4. evidence of hepatitis b and c 5. evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction 6. autoimmune hepatitis 7. drug-induced steatohepatitis (ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months) 8. any cardiovascular event or evidence of active cvs disease 9. type 1 diabetes 10. those consuming alcohol of over 20 grams/day for males and 10 grams/day for females 11. severe end-organ damage 12. human immunodeficiency virus (hiv) infection 13. compensated and decompensated cirrhosis 14. patients with uncontrolled diabetes 15. mental instability or incompetence
study to monitor the effects of androgen suppression treatment on the heart

Conditions: Prostate Cancer

Summary: suppression of effects of androgens with male sex hormones, androgen suppression treatment (ast), has been known to reduce deaths and prolong life in advanced prostate cancer. there have, however, been concerns raised in previous studies that androgen suppression may be associated with increased rate of heart attacks, particularly in older men. this study looks at prostate cancer patients in the ottawa hospital cancer clinic to see if treating these patients with androgen suppression is associated with a decrease in blood flow to the heart muscles by using positron emission tomography (pet) and brachial artery ultrasound.

treatment group: prior to the initiation of ast, subjects will have a baseline n-13-ammonia pet scan and a brachial artery ultrasound at the university of ottawa heart institute. blood glucose and a lipid profile will be obtained. these tests will be repeated 6 - 9 months after starting ast. cancer control group: the same testing and intervals will be performed. normals control group: baseline testing will be done to establish a normal.

Eligibility criteria:
inclusion criteria: cancer population: 1. diagnosis of prostate cancer 2. treatment group: scheduled to start ast, at ottawa hospital under the care of radiation oncology, urology or medical oncology. control group: no ast scheduled as a treatment option for prostate cancer. non-cancer control group 1. male with low pre-test likelihood of coronary artery disease 2. no previous history of cancer. exclusion criteria: 1. known coronary disease including any of previous revascularization, history of myocardial infarction, coronary disease with \>= 50% stenosis in a major coronary vessel on previous angiography, evidence of previous myocardial infarction on 12-lead electrocardiogram, positive myocardial perfusion scan, previous cardiac pet scan, stress echocardiogram or exercise stress test. 2. subjects with a summed stress score of \>4 attributed to coronary disease on baseline pet images 3. patients previously treated with ast 4. patients with a life expectancy of less than 1 year.

Keywords: androgen suppression therapy hormonal toxicity quantitative pet myocardial blood flow coronary blood flow reserve endothelial dysfunction coronary artery disease
erosive osteoarthritis of the hands: treatment by methotrexate versus placebo

Conditions: Polyarthritis

Summary: interest of methotrexate in inflammatory rheumatisms was demonstrated since several years. at present time,there is no effective treatment against digital arthritis. the investigators purpose to measure the efficacy of methotrexate on digital arthritis. in this aim, two groups were compared. the first group receive 10mg/week of methotrexate administered in one shot (every monday for example)during 12 months. the second group receive 10mg/week of placebo according to the same procedure


Eligibility criteria:
inclusion criteria: * hand arthritis * pain over 40/100 * stable treatment since 4 weeks at least with non-steroid analgesic * between 45 et 85 years exclusion criteria: * pregnancy or breast feeding women * hyaluronic acid injection within the past 6 months * cortisonic derivated injection within the past 3 months
emergence agitation after nasal surgery: a randomized controlled comparison between melatonin and mirtazapine

Conditions: Agitation

Summary: emergence agitation (ea) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation. melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults. mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.


Eligibility criteria:
inclusion criteria: 1. patients according to american society of anesthesiologists physical status classification (asa) i or ii. 2. patients according to mallampati classification i or ii. 3. patients accepting the study and consenting. 4. undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery. 5. body mass index(bmi)\<30 exclusion criteria: 1. patient's refusal. 2. known allergy to any of the study medications. 3. history of obstructive sleep apnea. 4. history of psychiatric illness or intake of antipsychotics. 5. history of liver impairment. 6. pregnancy. 7. history of uncontrolled hypertension. 8. history of renal disease. 9. body mass index (bmi) ≥30 kg/m2. 10. contraceptive drugs.
"efesovir" (fs-1) for covid-19, phase 2

Conditions: Covid19

Summary: study of the efficacy and safety of the new drug "efesovir" in comparison with the drug "remdesivir" in the treatment of patients hospitalized with covid-19. the hypothesis of clinical study is the clinical efficacy of new drug "efesovir" is 10% to 30% higher than of "remdesivir".


Eligibility criteria:
inclusion criteria: * polymerase chain reaction (pcr) confirmed coronavirus infection (covid-19) in hospitalized patients with severe risk factors in age from 18 years to 59 years, of both sexes, irrespective of national or ethnic origin * the duration of the covid-19 disease is no more than 10 days * informed concent to participate in clinical trials * informed concent to to use reliable contraceptive methods while participating in a clinical trial exclusion criteria: * age less than 18 years old and over 59 years old * pregnancy or breastfeeding * hypersensitivity, allergy, intolerance to iodine, iodine-containing medicines * hypersensitivity to remdesivir or its components * impaired consciousness, causing the impossibility of oral administration * conditions or circumstances that, in the opinion of the investigator, may affect the patient's safety or the quality of the results obtained * participation in another clinical trial, including in the period up to 2 months before this study * signs of multiple organ failure * alanine aminotransferase (alt), aspartate aminotransferase (ast) is 5 or more times higher than normal * thrombocytopenia below 100 \* 10\^9/ l * decrease in glomerular filtration rate (gfr) less than 30 ml / min by 1.73 m2 * chronic heart failure with reduced ejection fraction * liver failure * coagulopathy * mechanical ventilation for 48 hours or more * extracorporeal membrane oxygenation (ecmo) * disseminated intravascular coagulation

Keywords: covid19 viral pneumonia fs-1 efesovir