Kornimate/medical-research-clean huggingface dataset:
evaluation of the effect and tolerance of preservative free naaga on the inflammatory component and symptoms of dry eye syndrome in allergic conjunctivitis patients

Conditions: Allergic Conjunctivitis

Summary: multicentre, double blind, randomized, comparative study(comparing n-acetyl-aspartyl-glutamic acid(naaga) in abak preservative free device versus saline in abak preservative free device. evaluation of the effects and safety of naabak® through inflammation markers and symptoms in patients with allergic conjunctivitis and dry eye syndrome after 3 months treatment. the patients will attend 4 visits.


Eligibility criteria:
inclusion criteria: * age ≥ 20 years old * patients with dry eye syndrome in allergic conjunctivitis exclusion criteria: * severe dry eye syndrome * severe ocular pathology
evaluation of clp with and without spironolactone in heart failure patients with chronic kidney disease

Conditions: Heart Failure

Summary: the purpose of this study is to determine the effects of clp, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.


Eligibility criteria:
inclusion criteria: * heart failure with new york heart association (nyha) classification ii or iii * chronic kidney disease * cardiac ejection fraction \<40% * on heart failure therapy including an acei or arb, and a bb * willing to understand and comply with study procedures and provide written informed consent. exclusion criteria: * hospitalization within 4 weeks of baseline visit * history or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures * current or anticipated dialysis during study * in the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe * drug or alcohol abuse
bile duct injury digestif

Conditions: Surgery; Biliary Disease; Bile Duct Injury; Sepsis; Jaundice, Obstructive

Summary: data accumulated from medical record collected from january 2008 until december 2018


Eligibility criteria:
inclusion criteria: * adult patients with extrahepatic bile duct injury managed by digestive division of cipto mangunkusumo hospital exclusion criteria: * none
efficacy and pathophysiological implications of a new asphyxiation delaying device

Conditions: Avalanche, Landslide, or Mudslide; Asphyxia; Immersion

Summary: survival of fully buried avalanche victims depends in major part on a triad of hypoxia, hypercapnia, and hypothermia and therefore decreases rapidly after complete burial. besides optimizing companion rescue, which still today and even by trained people often takes more than 15 minutes to the extraction of an avalanche victim, prolonging the ability to breath after critical avalanche burial increases survival probability by giving rescuers more time to find and unbury avalanche victims. based on previous research, the norwegian company safeback se (bergen, norway) developed a new non-medical device using an innovative functional principle. the device, called the safeback sbx (safeback se, bergen, norway), should make it possible to prevent asphyxia by delivering fresh air to the air pocket. company claims to achieve a prolongation of survival up to over 60 minutes, giving companion rescuers as well as professional rescue teams more time to get access to the victim. technical tests conducted by the developing company already provided some promising results regarding the general functioning. however, this study is needed to provide the scientific evidence of the effectiveness and influence on physiologic parameters buried in snow debris humans under realistic conditions.


Eligibility criteria:
inclusion criteria: - healthy asa i subjects exclusion criteria: * asa class ii or higher * chronic high degree cardiovascular or pulmonary disease * claustrophobia * psychiatric or neurological disease * long-term medication * pregnant woman * no informed consent * history of fever or serious cough in the past two weeks * current covid-19 symptoms or recently tested positive for covid-19 * body temperature ≥ 37.5°on test days.

Keywords: avalanche avalanche burial cardiac arrest asphyxia emergengy medicine
efficacy and safety of piemonte association in the treatment of type ii diabetes mellitus

Conditions: Type II Diabetes

Summary: the purpose of this study is to evaluate the efficacy and safety of piemonte association in the treatment of type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the consent form; * diagnosis of type ii diabetes mellitus, and who did not reach the therapeutic goal of hba1c with previous dietary, physical exercise, and previous therapies at stable doses within 3 months. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of participants; * history of alcohol abuse or illicit drug use; * participation in a clinical trial in the year prior to this study; * pregnancy or risk of pregnacy and lactating participants; * known hypersensitivity to any of the formula compounds; * type 1 diabetes.

Keywords: type ii diabetes mellitus
study of pazopanib monotherapy in patients with unresectable, metastatic neuroendocrine tumor

Conditions: Neuroendocrine Tumor

Summary: to determine the response rate of pazopanib when administered as monotherapy in patients with unresectable neuroendocrine tumor.


Eligibility criteria:
inclusion criteria: * low to intermediate grade neuroendocrine tumor not amenable to surgery or local therapy exclusion criteria: * poorly differentiated (high grade or anaplastic)/small cell, pheochromocytoma

Keywords: neuroendocrine tumor
ability of patients with low vision to properly instill eye drops

Conditions: Glaucoma; Retinal Pathology

Summary: the investigators are interested in seeing how people with low vision (decreased visual acuity or restricted visual fields) instill eye drops into their own eyes. the investigators hypothesis is that this population will have more difficulty with self-instillation of drops than a better-seeing population. the investigators aim to explore whatever factors may be involved in preventing this population from getting prescribed eyedrops into their eyes, whether it is more related to visual field or visual acuity.

this is a study that involves a questionnaire that a study participant fills out, detailing their experience with eyedrops (if any), followed by a video recording of them instilling artificial tears into their worse-seeing eye, with their dominant hand. patients must have visual acuity worse than 20/60 in at least one eye, and/or have a recent visual field that demonstrated hodapp criteria for moderate or severe visual field damage. this is an observational study of how patients with low vision due to either glaucoma or retinal disease instill eyedrops. each video will be "graded" by the principal investigator for "success" at instilling eyedrops, and patients will be stratified by their visual acuity or visual field, and whether they have a primary diagnosis of glaucoma or retinal disease.

Eligibility criteria:
inclusion criteria: * etdrs visual acuity 20/60 or worse exclusion criteria: * unwilling to participate * light perception vision * no light perception vision

Keywords: compliance eyedrop instillation how patients with low vision due to glaucoma or retinal pathology instill eyedrops into their own eyes.
ultrasound-guided fascia iliaca compartment block versus periarticular infiltration

Conditions: Postoperative Pain

Summary: this randomized, controlled, observer-blinded study clinical trial was designed to evaluate ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.

despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated. optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects. patients undergoing total hip arthroplasty (tha) (n=60) at parkland and ut southwestern medical center hospitals will be randomized into one of two groups to receive either ultrasound-guided fascia iliaca compartment block (ficb) with ropivacaine 300 mg and 0.5 mg epinephrine (group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine total (group 2) for postoperative pain management. the remaining aspect of perioperative care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative care will be standardized and will be similar for all patients. the duration of the involvement in the study will be until 48 hours postoperatively. patients in group 1 will receive ultrasound-guided ficb after surgery. patients in group 2 will receive ropivacaine via periarticular infiltration prior to closing the incision. the postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). in addition, total opioid dose over the 48-h study period will be documented. postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. rescue antiemetics will be given to any patient who complains of nausea and/or vomiting. all variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.

Eligibility criteria:
inclusion criteria: * female asa physical status 1-3 scheduled for total hip arthroplasty * age 18-80 years old * able to participate personally or by legal representative in informed consent in english or spanish exclusion criteria: * history of relevant drug allergy * age less than 18 or greater than 80 years * chronic opioid use or drug abuse * significant psychiatric disturbance * inability to understand the study protocol * refusal to provide written consent

Keywords: nerve block periarticular infiltration ropivacaine pain
evaluation of proprioceptive abilities while wearing an elastic orthosis in patients with proprioceptive knee deficits

Conditions: Proprioceptive Disorders

Summary: the objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.

this proprioceptive deficit is found following various traumas or injuries such as anterior cruciate ligament (acl) rupture, for example. the use of joint stabilizers (such as knee braces) will allow an increase in sensory input (particularly at the level of cutaneous mechanoreceptors), and improve the biomechanics of the injured joint. the objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.

Eligibility criteria:
inclusion criteria: * patient with a proprioception deficit of the knee: detection threshold higher than 2.5° on the ttdpm (threshold to detect passive motion) test * patient whose knee measurements are compatible with the sizes of the proprioceptive knee brace * patient having signed a free and informed consent form * patient affiliated or entitled to a social security plan exclusion criteria: * patient with knee pain on walking greater than or equal to 4 out of 10 on a vas scale. * patient in the early phase of acute trauma to the lower limb * patient having worn a knee brace in the 48 hours prior to inclusion * pregnant women * patient presenting one of the contraindications to the use of the knee brace, indicated in the instructions for use * patient with a major cognitive impairment incompatible with participation in a clinical trial * patient participating in another clinical investigation conducted to establish the conformity of a dm (medical device) impacting the judgment criteria * vulnerable patient according to article l1121-6 of the public health code, person subject to a judicial protection measure or unable to consent freely

Keywords: anterior cruciate ligaments rupture proprioceptive knee brace rehabilitation
feasibility study to evaluate therapeutic ultrasound (tus) to acutely increase the perfusion in peripheral arterial disease (pad)

Conditions: Peripheral Arterial Disease

Summary: this study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (pad) patients 65 years of age and over.

the vibratosleeve tus will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage pad. each subject will receive tus treatment multiple sessions. all post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Eligibility criteria:
inclusion criteria: 1. age ≥ 65 2. diagnosis of pad. 3. claudication symptoms in rutherford class 1,2, or 3 as determined by the investigator. exclusion criteria: 1. prior stenting in posterior tibial artery. 2. re-vascularization procedure within 30 days prior to enrollment in the study. 3. ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf). 4. history or diagnosis of severe chronic venous insufficiency. 5. acute limb ischemia within 30 days prior to treatment. 6. history or diagnosis of deep venous thrombosis below the knee in treatment leg. 7. any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data. 8. subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period. stenting in posterior tibial artery.

Keywords: therapeutic ultrasound (tus) peripheral artery disease (pad) critical limb ischemia (cli)
emervel for the correction of lower face wrinkles & folds

Conditions: Nasolabial Folds; Marionette Lines; Wrinkles

Summary: this study is designed to 1. evaluate the naturalness of facial expressions in motion (2d video images), by treating investigator assessment 2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment 3. evaluate perceived attractiveness and age of subject (2d videos), by treating investigator assessment 4. evaluate aesthetic improvement, by subject and treating investigator assessments 5. evaluate subject satisfaction 6. evaluate nasolabial fold (nlf) severity, by treating investigator assessment 7. evaluate marionette lines (mls) severity, by treating investigator assessment 8. evaluate dynamic facial strain in animation using 3d digital photogrammetric analysis 9. evaluate all adverse events reported during the study.


Eligibility criteria:
key inclusion criteria: 1. seeking correction of bilateral nlfs: severe (i.e., bilateral wsrs = 3-4) or moderate (i.e., bilateral wsrs = 2-3) and bilateral mls: severe (i.e., was = 3-4) or moderate (i.e., was = 2-3). 2. subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion. 3. intent to undergo optimal correction of bilateral nlfs and mls. optimal correction is defined as the best possible aesthetic outcome as agreed to by the treating investigator and subject. key exclusion criteria: 1. subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction. 2. previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area. 3. previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area. 4. previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment. 5. known/previous allergy or hypersensitivity to any injectable hyaluronic acid (ha) gel. 6. known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics. 7. known/previous allergy or hypersensitivity to gram-positive bacterial proteins. 8. any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study). 9. other condition preventing the subject from entering the study in the treating investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.
intra-rectal botulinum toxin injection for intractable non-retentive fecal incontinence in children - an open label pilot study

Conditions: Fecal Incontinence

Summary: background: fecal incontinence (fi) is a frustrating and prevalent gi condition with profound social implications and a marked effect on quality of life. treatment options are limited for children whose fi is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (nrfi). rectal botulinum injections (rbi) have recently shown promise for the treatment of fi in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children. objectives: to evaluate the efficacy and safety of rbi in children with non-retentive fecal incontinence. methods: a prospective open-label pilot study. children with intractable nrfi will be screened using anorectal manometry and a colonic transit study. eligible patients will receive one course of rbi and data regarding fi frequency will be prospectively collected during a 15-week period. significance: new treatment options for children with intractable fecal incontinence are highly in need. the current study aims to introduce a new treatment modality into pediatric research and patient care.


Eligibility criteria:
inclusion criteria: * children 4-18 years old with fecal incontinence for a period greater than 6 months. * fi frequency of ≥ 3 episodes/week. * after appropriate medical evaluation, fi cannot be explained by another medical condition. * normal colonic transit study, defined as passage of 80% of markers on day * normal rair on anorectal manometry exclusion criteria: * patients currently fulfilling rome iv criteria for functional constipation. * patients with evidence of fecal retention. * patients who had had good response to treatment for overflow incontinence. * absent rair on anorectal manometry. * any radiologic evidence of dochylosigmoid or distended colon. * any known organic condition that may affect bowel transit.
international, multicenter, study of one-year, open-label, titrated oral tolvaptan tablet administration in patients with chronic hyponatremia

Conditions: Hyponatremia

Summary: this study will assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term phase 3 studies and gather information on the natural history of hyponatremia in the context of tolvaptan therapy and underlying disease states.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years. 2. ability to provide informed consent or assent. 3. prior successful participation in a tolvaptan hyponatremia trial termination with evidence of continued need or desire for therapy. exclusion criteria: * a current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient. * hyponatremia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy. * hyponatremia due to reversible medical condition or therapy * conditions associated with an independent imminent risk of morbidity and mortality * conditions which confound the assessment of endpoints.

Keywords: hyponatremia
erythrocytapheresis versus phlebotomy as maintenance therapy in hereditary hemochromatosis (hh) patients

Conditions: Hereditary Hemochromatosis

Summary: hereditary hemochromatosis (hh) is a genetic disorder of iron metabolism, resulting in excessive iron overload. phlebotomy is currently the standard therapy. more recently therapeutic erythrocytapheresis (te) has become a new therapeutic modality, which potentially offers a more efficient method to remove iron overload with fewer procedures.in the proposed clinical trial the investigators will examine whether te can keep the ferritin levels in patients requiring maintenance therapy below 50 microg/l, with minimally half the number of treatment procedures when compared to current standard therapy by p.

the research population exists of patients with hh ( by genetic analysis confirmed as homozygous for c282y) living in south-east of the netherlands and currently treated with phlebotomy as maintenance treatment to keep their serum ferritin levels \ 35). after enrollment the patients will be randomized to start either with te or continue with p. after a year of treatment and being at a serum ferritin level \<50ug/l, patients will continue the study but then being treated with the other of the two treatments. randomization will be done by blocked randomization.

Eligibility criteria:
inclusion criteria: * homozygous for c282y * currently treated with phlebotomy as maintenance therapy for at least 6 month * ferritin level between 30-50 micog/l * age 18 years an older * weight more than 50 kg * signed informed consent * willingness to fill out additional questionnaires at three points in time exclusion criteria: * chelating therapy * forced dietary regime * aged below 18 years * excessive overweight ( bmi more than 35) * pregnancy

Keywords: phlebotomy therapeutic erythrocytapheresis hereditary hemochromatosis maintenance therapy
app-based education program for ckd

Conditions: Renal Insufficiency, Chronic

Summary: a randomized control trial to test the effect of a mobile app-based educational program for chronic kidney disease patients.


Eligibility criteria:
inclusion criteria: * diagnosed with ckd stage 1\~5 * have been receiving ckd treatment for more than 6 months * owns an android mobile phone exclusion criteria: * diagnosed with cancer within 5 years of recruitment