Kornimate/medical-research-clean huggingface dataset:
effect of an educational and explanatory program for a surgical act on preoperative anxiety

Conditions: Preoperative Anxiety

Summary: the main objective of this study is to evaluate the impact on preoperative anxiety of an education and information program conducted prior to non-urgent coronary angiography performed in patients hospitalized at the nîmes university hospital.

the secondary objectives of this study are to assess the impact of the heartlink program on the following parameters: a. duration of hospital stay; b. per operative blood and heart rate?; c. patient satisfaction (visual analog scale).

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * patient for whom elective coronary angiography is indicated * the patient has never had a coronary angiography before exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant or breastfeeding * the subject has already had a coronary angiography * the subject has a cognitive impairment

Keywords: coronary angiography
study to evaluate dnl747 in subjects with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of dnl747 in subjects with alzheimer's disease when administered for 29 days in a cross-over design

this is a phase 1b randomized, placebo-controlled, double-blind, crossover study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of dnl747 in subjects with alzheimer's disease (ad)

Eligibility criteria:
key inclusion criteria: * women of non-childbearing potential and men, aged 55-85 years * ad diagnosis based on the 2011 national institute on aging-alzheimer's association guidelines * supportive evidence for diagnosis of ad based upon positive csf aβ42 test, or documented history of positive amyloid-specific pet scan * screening mmse score of 16-26 points * screening cdr global score of 0.5-1.0 * availability of a person ("caregiver") who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits that require input for scale completion, assists the participant with compliance for at-home study treatment administration, and signs the necessary consent form (note: the caregiver is not required to stay in the unit) * approved ad treatments (acetylcholinesterase inhibitors ± memantine) and other prescription medications must be stable for ≥1 month prior to screening and anticipated to be stable over the duration of the study key exclusion criteria: * clinical history within 2 years of the screening visit or current evidence of any neurological or neurodegenerative disorder other than ad that is associated with transient or sustained alterations in cognition * magnetic resonance imaging (mri) at screening (or within 1 year of screening visit) consistent with any neurological or neurodegenerative disorder other than ad that is associated with transient or sustained alterations in cognition
continuous ekg monitoring using s-patch ex : prospective observational study (s-patch registry)

Conditions: Patient With Atrial Fibrillation or High Stroke Risk

Summary: atrial fibrillation (af) is associated with increased mortality and morbidity, and is a dominant, yet preventable, cause of cardioembolic stroke, which has more severe outcomes than other ischaemic stroke causes if left untreated. approximately 10% of ischemic strokes are associated with af (af) first diagnosed at the time of stroke. detecting asymptomatic af would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. early diagnosis of af might enable oral anticoagulant therapy and prevent unwanted consequences of undetected disease, leading to the suggestion that screening for af might be beneficial in populations at risk. however, there is still debate about whether screen-detected af bears a similar stroke and mortality risk profile to clinically detected af, particularly when af screening is done at a higher intensity than single-time point. the absence of studies reporting on hard clinical endpoints in af screening has led to differences in recommendations globally. most notably, systematic screening for af is to be considered according to 2020 european guidelines, whereas the us preventive services task force concluded that current evidence is insufficient to assess the balance of benefits and harms of screening for af. the incidence of screen-detected af strongly depends on the population screened and duration/intensity of screening. single-time point screening of a general population ≥65 years of age detects undiagnosed af in 1.4%, and the af detected is largely persistent. in a large population-based study of individuals 75 to 76 years of age, a more intense 2-week screening program using twice-daily intermittent handheld ecg recordings identified af in 3.0% (0.5% on the initial ecg4). the identical protocol restricted to those with ≥1 additional stroke risk factor identified 7.4% with af. this study was designed in to two arms. the purpose of arm 1 is to upgrade the artificial intelligence by collecting the continued ecg monitoring data in patients with previous diagnosed af. the purpose of arm 2 is to investigate the detection rate of af using systematic, intensive af screening with continuous ecg monitoring and the rate of clinical outcome in individuals at high risk during one year follow-up.

arm 1 patients with af are examined with 72 hour continued ecg monitoring arm 2 patients with high stroke risk (cha2ds2-vasc score \>=2) are examined with 72 hour continued ecg monitoring

Eligibility criteria:
inclusion criteria: 1. patients who are over the age of 19 2. those with previous diagnosis of atrial fibrillation 3. those without atrial fibrillation, but high stroke risk exclusion criteria: 1. those who refuse to participate in the trial. 2. those without internet connection

Keywords: atrial fibrillation stroke risk ekg continuous
ambulatory parkinson's disease dyskinesia monitor for drug therapy titration

Conditions: Parkinson's Disease

Summary: the objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in parkinson's disease.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease * clinical history of levodopa-induced dyskinesia * 21 years of age or older * stage 2 - 4 off-medication on the hoehn and yahr scale exclusion criteria: * dementia (determined by a neuropsychological assessment) * severe tremor unaffected by levodopa
laser acupuncture for pain prevention in neonates

Conditions: Pain

Summary: pain prevention and/or therapy in neonates is still a challenge. it is widely accepted that early pain experience can have a tremendous impact on the pain memory. we want to investigate if a simple, fast method, that is nearly devoid of side effects can lead to a significant alleviation of pain sensation in neonates. acupuncture has been shown to be effective in various painful conditions. trials on acupuncture in children are rare. trials on acupuncture in neonates are lacking so far. our hypothesis is that neonates in the active laser group experience less pain than those in the placebo group.


Eligibility criteria:
inclusion criteria: * neonates with no obvious underlying disease (genetic (e.g. m. down), metabolic)and not under pain medication exclusion criteria: * older than 28 days

Keywords: pain prevention neonatal pain laser acupuncture complementary and alternative medicine
clinical trial of glatiramer acetate in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: teva is developing 40 mg/ml glatiramer acetate (ga) injection , administered once daily under the skin, for the treatment of als. the study drug is a higher dose formulation of copaxone® (20 mg/ml ga), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. ga is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in als. the study treatment duration is 1 year (52 weeks).


Eligibility criteria:
inclusion criteria: 1. diagnosis of definite or probable als in accordance with the el-escorial criteria. 2. subject has experienced his/her first als symptoms within 3 years prior to the screening visit. 3. slow vc test equal or greater than 70% of the predicted value. 4. the sum of the 3 respiratory items on the alsfrs-r must total at least 10 points. 5. stable dose of riluzole for at least 8 weeks prior to screening. 6. age - 18-70 (inclusive). exclusion criteria: 1. the use of invasive or non-invasive ventilation. 2. subject having undergone gastrostomy. 3. subject with any clinically significant or unstable medical condition. 4. subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter). 5. additional criteria per protocol.
potential benefits of itopride in the management of patients with metabolic associated fatty liver disease (mafld)

Conditions: Fatty Liver Disease; Fatty Liver

Summary: objective of this study is to determine the clinical benefits of itopride in improvement of mafld

the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease

Eligibility criteria:
inclusion criteria: * patients presented to hepatology clinic . -patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - - * patients with comorbidites like hypertension,diabetes,dyslipidemia exclusion criteria: * exclusion criteria included the presence of liver disease due to any of the following: viral hepatitis (hbv, hcv) * acute systemic disease * cystic fibrosis, coeliac disease * suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency * metabolic inherited diseases * autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone). * patients were also excluded if body weight and carbohydrate metabolism were altered by the use of parenteral nutrition * protein malnutrition * previous gastrointestinal surgery * structural abnormalitiesof the gastrointestinal tract or neurological impairment. * the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1 * probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months preceding enrolmentwere also considered exclusion criteria. * patient with age below 18 or above 60

Keywords: itopride in mafld
efficacy and safety of a probiotic formulation in adults with irritable bowel syndrome with diarrhea (ibs-d)

Conditions: IBS - Irritable Bowel Syndrome

Summary: the purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with ibs-d.

to monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with ibs-d.

Eligibility criteria:
inclusion criteria: * experiencing symptoms of ibs-d * having a diagnosis of ibs-d based on rome iv criteria * participants with symptom onset at least 6 months before diagnosis * having a normal colonoscopy result in their medical file exclusion criteria: * a history of inflammatory or immune-mediated gastrointestinal diseases * diagnosed with a co-existing organic gastrointestinal disease which can affect the study * currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease, * currently diagnosed with an eating disorder, * having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy * currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation, * regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is \> once per month a one month wash out is needed, * unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study, * pregnant, breast-feeding or planning on becoming pregnant.

Keywords: ibs-d probiotics
atropine in laparoscopic gynaecological surgery

Conditions: Laparoscopic Surgery; Gynecology

Summary: this is a double blinded, randomised controlled trial that will compare atropine to placebo for postoperative pain in laparoscopic gynaecological surgery

patients that meet eligibility criteria will receive a standardised general anesthesia based on sevoflurane and opioids and will be randomised in two groups, using computer generated randomisation system. allocation concealment is established on opaque envelopes that contain random allocation. anesthesia depth will be measured by bispectral index (bis), titration of sevoflurane to a bis of 45-60. in case of neuromuscular block reversal at the end of surgery, sugammadex will be administered. at induction, 1 mg iv atropine 0.1% or 10ml saline will be administered, depending on group allocation, on a syringe prepared by an anaesthesiologist not involved in the study. patients will receive ketorolac 30 mg/8h, acetaminophen 1g/8h and a morphine iv patient controlled anaesthesia pump (pca) 0-1-8 outcomes will be evaluated at the postoperative care unit (pacu) and 24 postoperative hours by an investigator blinded to study group

Eligibility criteria:
inclusion criteria: * american society of anesthesia (asa) class i-ii, gynaecological laparoscopic surgery lasting ≥30' of laparoscopic time, bmi \<35 exclusion criteria: * known allergies to study drugs, concomitant surgeries, patients with closed angle glaucoma, history of coronary disease or heart insufficiency, beta.blockers

Keywords: atropine pain, postoperative
arthroscopic treatment combined with prp injection for refractory elbow epicondylitis

Conditions: PRP; Lateral Epicondylitis

Summary: this study is a prospective randomized controlled study of different arthroscopic treatments for refractory external humeral epicondylitis combined with platelet rich plasma (prp) injection. the patients with intractable external humeral epicondylitis were randomly divided into groups before the operation. after the arthroscopic operation was completed, they were divided into a local prp injection group and a control group (normal saline) to perform additional operations on the damaged tendons, each for up to half a year after the operation. in different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, mri performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with prp on the treatment of damaged tendons. determine the effectiveness of prp. at the same time, in the process of arthroscopic treatment, look for risk factors that affect the curative effect of intractable external humeral epicondylitis, as well as the causes and prevention of common complications.


Eligibility criteria:
inclusion criteria: * clinically diagnosed patients with refractory external humeral epicondylitis (preoperative mri confirmed loss of ecrb integrity) patients who have received non-surgical treatment with poor efficacy * young and middle-aged patients aged 20 to 60, who have not previously received local injection therapy * voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients * no other comorbidities or medical diseases affect the surgical patients * unilateral disease exclusion criteria: * early patients who have not received standard non-surgical treatment * patients who have received hormone injections or "small needle knife therapy" and other invasive procedures within three months before surgery, poor skin conditions, and local infections * elderly people older than 60 years old and patients younger than 20 years old * unable to accept randomization, insufficient follow-up time or lost to follow-up * bilateral disease * combined immune disease
cryotherapy & oxaliplatin

Conditions: Colon Cancer; Peripheral Neuropathy

Summary: the primary objective of this study is to determine if cryotherapy is beneficial to patients with colon cancer who are receiving oxaliplatin in the prevention of developing chemotherapy induced peripheral neuropathy.

peripheral neuropathy often manifests as numbness and tingling in the hands and feet, which may be detrimental to the patients' overall safety and quality of life, thereby causing them to stop or delay treatment. everyday tasks such as walking, buttoning a shirt, or tying shoes can become challenging. select chemotherapy agents are known to cause significant peripheral neuropathy. studies have been performed demonstrating efficacy of using cryotherapy, which causes vasoconstriction, to targeted areas of the body, in relation to paclitaxel. these studies have shown drastic differences between those who receive cryotherapy during treatment and those who do not. there are few studies on the use of cryotherapy in the prevention of peripheral neuropathy with the use of oxaliplatin, which will be undertaken in this study.

Eligibility criteria:
inclusion criteria: * over the age of 18 years * willingness to participate in research * diagnosed with stage iii colon cancer * chemotherapy naïve * planning to initiate capecitabine + oxaliplatin (capox) chemotherapy regimen as part of standard of care. exclusion criteria: * pre-existing peripheral neuropathy * pre-existing diabetes * raynaud's disease * metabolic syndrome, including: hypertension; hypercholesterolemia; and obesity (bsa \> 2) * upper extremity amputees * specific autoimmune diseases: guillain-barre; lupus; rheumatoid arthritis; and sjogren's syndrome
cpet in cf patients with one g551d mutation taking vx770

Conditions: Cystic Fibrosis

Summary: ivacaftor will restore cftr function in treated cf patients with the g551d mutation. improvement in ventilation, salt balance and well-being will contribute to better exercise capacity at all levels of lung function. while potential improvements may be variable across the spectrum of lung function, even small gains at low levels of fev1 may have significant benefit for some subjects.

the alfred cf service is ready to initiate therapy with vx-770 in it's cohort. investigators therefore have an opportunity to examine correlates between improvements in lung function, exercise capacity, inflammatory markers and indices of wellbeing in cf that may not be repeatable in a single cohort. investigators propose a double-blind, placebo-controlled cross-over study of 20 patients currently awaiting initiation of ivacaftor therapy. patients enrolled in the study will be asked to undergo screening (day -28), and baseline assessments (day 0) and re-assessment studies (day 28) after treatment period 1, followed by baseline assessment at the beginning of treatment period 2 (day 56) and at the conclusion of treatment period 2 (day 84). a further assessment (day 224) will be performed 140 (+/-7) days following commencement on open label ivacaftor. after satisfying eligibility criteria, subjects will be randomly assigned to initial active treatment or placebo following a 4 week run-in period. after completion of period 1 and a 4 week washout period, subjects will cross-over to the alternative treatment. after 4 weeks of period 2, subjects will undergo final assessment as shown in the diagram below. however participants choosing not to continue taking ivacaftor in a named patient program or another similar program run by vertex pharmaceuticals, inc., ('vertex'), at the end of the study period will be required to undergo a safety follow-up visit 28 days after the final dose of study drug. safety follow-up assessments will not include the cpet.

Eligibility criteria:
inclusion criteria: * all participants will have cf proven based on established criteria (sweat test, genotype and phenotype). * all participants will have at least one copy of the g551d mutation. * all will be able to perform an exercise study and complete study questionnaires and assessments. * age range will be between 16 and 75 years of age. * lung function inclusion will be above 25% predicted fev1. exclusion criteria: * participants will not be included if they are unable to complete study assessments or have had a known adverse reaction to ivacaftor. * female participants will be excluded if found to return a positive pregnancy test at screening. * participants will be excluded if using st. john's wort or rifampicin (strong cyp3a inducers). * participants with significant liver dysfunction will be excluded (alt or alt above 5 times upper limit of normal).

Keywords: eligible cf patients with g551d gene mutation
nu-desc dk: the danish version of the nursing delirium screening scale

Conditions: Delirium

Summary: delirium is one of the most common complications among elderly hospitalized patients, postoperative patients and patients on intensive care units. the reported prevalence is between 11 and 80 %. delirium is associated with a high morbidity and threefold higher 6-month mortality. the nursing-delirium screening scale (nu-desc) is a screening tool with a high sensitivity and specificity. the purpose of this study is to translate the nu-desc to danish and evaluate afterwards its feasibility and understanding by different medical staff. material and methods: the nu-desc will be translated after international society for pharmacoeconomics and outcomes research (ispor) guidelines to danish by permission of the original author. the evaluation will be performed, by filling out evaluation forms, where the feasibility and understanding will be rated on a 6 step likert scale.

translation of the original tool and evaluation of understanding and feasibility by medical staff.

Eligibility criteria:
inclusion criteria: * medical staff working in the recovery room or orthopedic ward exclusion criteria: * medical staff from other wards

Keywords: mass screening nursing diagnosis psychiatric status rating scale
assessing gene-environment interactions in clinical presentation of nevi and melanoma

Conditions: Nevi and Melanomas

Summary: this research study is designed to better understand the role of genetics, sun-exposure and phenotypic factors in melanoma.


Eligibility criteria:
inclusion criteria: 1. \> or = 18 years of age 2. patient at the university of colorado anschutz medical campus cutaneous oncology clinic or dermatology clinic or attend the fundraising event of the colorado melanoma foundation exclusion criteria: 1. no exclusion criteria listed

Keywords: sun exposure uv dosimetry biomarkers behaviors genetics