Kornimate/medical-research-clean huggingface dataset:
novel breath test to detect early stage chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: the goal of this study is to evaluate the feasibility of using a non-invasive, non-radioactive pancreatic breath test (pbt) as a diagnostic tool to detect early stages of chronic pancreatitis (cp). if successful, this method could have important advantages over existing diagnostic tests for detecting early stage cp. this diagnostic breath test may have a clinical impact if it leads to early detection of cp and intervention to mitigate disease progression.

disorders of the pancreas affect more than one million persons in this country with nearly $3 billion in health care costs. the incidence rate of chronic pancreatitis (cp) is rapidly increasing and may be related to expanded alcohol abuse. advanced cp can be easily detected by imaging techniques. however, mild to moderate cp presents a more difficult challenge for clinicians. imaging techniques fail to recognize less advanced cp cases about 40% of the time. the gold standard for monitoring early stage cp is the secretin stimulation test. however, the secretin stimulation test is only done in a few us centers. the investigators have developed the pancreatic breath test (pbt) as an alternative to the secretin stimulation test. the breath test uses a tracer dose of sodium 13c-bicarbonate to detect the amount of bicarbonate released after stimulation of the pancreatitis by a meal (liquid ensure). a normal pancreas releases unlabeled bicarbonate upon stimulation, decreasing the ratio of 13c/12c of exhaled carbon dioxide. this ratio will change much less in a diseased pancreas. a case-control study in 25 mild to moderate cp patients and 25 healthy controls will be utilized to show feasibility of the new breath test.

Eligibility criteria:
inclusion criteria: * male of female greater than or equal to 18 years of age. * subjects must have the ability to give informed consent. * female subjects of child bearing potential must use a medically acceptable form of birth control and have a negative pregnancy test. * for case subjects with mild to moderate chronic pancreatitis, they must have either an abnormal endoscopic ultrasound (greater than 4 abnormalities), an abnormal secretin stimulation test, an abnormal endoscopic retrograde cholangiopancreatography (ercp), an abnormal ct scan of the pancreas (dilation of the main pancreatic duct or atrophy of the pancreas), a serum trypsin level \ 20 ng/ml, or a fecal elastase of less than 200 mcg/gram stool but greater than 100 mcg/gram stool. exclusion criteria: * females who are lactating or pregnant. * subjects with acute pancreatitis. * subjects known to have a significant medical and/or mental disease. * subjects receiving an investigational new drug within 30 days. * subjects on enzyme therapy, proton pump inhibitors, h2 receptor antagonists. * subjects who have had a recent febrile illness within 5 days of scheduled entry into the study. body temperature must be normal for at least 72 hours before entering the study.

Keywords: chronic pancreatitis breath test bicarbonate
aggressive spinal hemangioma

Conditions: Aggressive Spinal Hemangiomas

Summary: this research is a case series analysis to evaluate aggressive vertebral hemangiomas. it focuses on clinical presentation, diagnostic imaging accuracy (x-ray, mri, msct, angiography), and treatment efficacy. the primary goal is to establish optimal management protocols.

hybrid methodology integrating retrospective case reviews (from assiut university hospital's orthopedic surgery department) with synthesis of existing literature. objectives: characterize clinical presentations and imaging findings. compare diagnostic accuracy across modalities. analyze treatment outcomes, including procedural success rates and complications. tools: imaging: x-ray for initial screening, mri/msct for soft tissue and spinal cord involvement, angiography for vascular mapping.

Eligibility criteria:
inclusion criteria: * patients diagnosed with aggressive spinal hemangiomas based on clinical symptoms and imaging findings. * cases confirmed through diagnostic modalities such as x-ray, mri, msct, or angiography. * patients presenting with symptoms such as pain, neurological deficits, or spinal instability attributable to the hemangioma. exclusion criteria: * patients with incidentally discovered spinal hemangiomas (asymptomatic cases found during evaluations for unrelated conditions). * cases lacking sufficient diagnostic evidence to confirm aggressive spinal hemangioma.

Keywords: hemangiomas management
comparing the outcomes between rotator cuff repair with and without suprascapular nerve decompression

Conditions: Rotator Cuff Tear

Summary: the purpose of the study is to compare the differences in outcome between the traditional rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression surgery.

the suprascapular nerve is intimately related to the function and likely recovery of the rotator cuff musculature. retracted rotator cuff tears have recently been shown to effect both the physical path in which the suprascapular nerve travels, as well as its physiologic function. this study will be a randomized control trial with long term follow up that will add to and elaborate on the positive outcomes reported in other trials. patients that have a rotator cuff tears with greater than or equal to 1 cm of retraction that have failed conservative treatment and require operative repair will qualify for the study. they will be randomized into two arms: in one arm, patients will undergo suprascapular nerve release immediately after their rotator cuff repair; they will be compared to patients that have rotator cuff repair with no release of the nerve. post operatively, at different time intervals, patients will be expected to fill out multiple standardized, well established surveys that assess the patients pain level and shoulder function.

Eligibility criteria:
inclusion criteria: * reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction exclusion criteria: * patients less than 18 years of age * irreparable rotator cuff tears

Keywords: randomized controlled trial rotator cuff tear suprascapular nerve decompression shoulder surgery
3 year follow up study of the idea population

Conditions: Autism

Summary: the aim of this study is to assess the efficiency of early treatment for asd children 5 years after initial treatment. the early treatment implemented was 12 hours per week of esdm versus treatment as usual during 2 years. this was done as an rct, called idea. children will now be included in idea-2 scola, a three year follow up study.

180 children with asd, younger than 3 years old, were included in the idea rct. children were allocated to the esdm treatment group or the treatment as usual group. the aim of idea-2 is to follow-up this population for 3 years after the initial 2 years of intervention, that is, 5 years after initial inclusion to idea. investigators hypothesize that children who received esdm 12 hours per week will have a significant decrease of autism symptoms and will have a better scholastic level 5 years after initial inclusion to idea.

Eligibility criteria:
inclusion criteria: * inclusion in the initial idea trail * requiring less than 40 minutes travel to the assessment center exclusion criteria: * impossibility of coming in for assessment * exclusion from idea
a clinical study of sph7854 granules in healthy subjects.

Conditions: Inflammatory Bowel Disease

Summary: to evaluate the safety of sph7854 in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. volunteer to participate in clinical research; fully understand and know the study and sign the informed consent； 2. healthy volunteers; 3. before receiving the investigational drug, the examination results were normal or clinically insignificant; 4. subjects who have no fertility plan/sperm donation/egg donation plan and voluntarily take effective contraceptive measures, from signing the informed consent to the prescribed time after the last dosing. exclusion criteria: 1. female subjects who are breastfeeding or have positive pregnancy results; 2. subjects with chronic, unstable, or recurrent disease or surgery history who are judged by the investigator to be ineligible before signing informed consent; 3. subjects suffering from allergic diseases or having a history of severe allergies; 4. subjects who took the drug or food prohibited by the protocol prior to the first dose; 5. subjects with evidence of infection who could not be enrolled according to the investigator's judgement; 6. other circumstances that meet the protocol exclusion criteria.
interprofessional education and collaborative practice model for dementia in acute care

Conditions: Dementia

Summary: the purpose of this study is to develop an interprofessional education and practice model for acute care related to dementia and evaluate its effectiveness of implementation.

the researchers will recruit participants from a medical center (experimental group) and two regional hospitals (control group) in southern taiwan. both the experimental group and the control group will contain 150 healthcare professionals and 64 patients with dementia. both of the groups will receive a six-hour dementia care course. then, only the experimental group will receive a half-day interprofessional education workshop, maintain a six-month interprofessional practice model, and join interprofessional practice experience-sharing conferences. the evaluation of outcomes will include the analyses of healthcare professionals' knowledge, attitudes, and self-efficacy of dementia care. the evaluation times are to be before and after the dementia care course and after the six months of interprofessional practice. the other evaluation of outcome is comparison of the outcomes of hospitalized patients with dementia between the two groups before the interprofessional education workshop and after the interprofessional practice.

Eligibility criteria:
inclusion criteria: * healthcare professionals having worked for 3 months or more * emergency/hospitalized patients with dementia * patients diagnosed dementia * scoring 1 or more in clinical dementia rating (cdr). exclusion criteria: * healthcare professionals working in obstetrics, pediatrics, outpatient, or hemodialysis.

Keywords: dementia hospital acute care interprofessional education interprofessional practice
study using the cervicalstim device following cervical fusion

Conditions: Vertebral Cervical Fusion Syndrome; Degenerative Disc Disease

Summary: this study examines the effect of adjunctive use of the cervicalstim bone growth stimulator on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. all participants will wear the bone growth stimulator every day for 4 hours/day for 6 months.

the purpose of this post market prospective study is to examine the effect of the adjunctive use of the orthofix cervicalstim device on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. high risk subjects are those who are having a multi-level (2 or more) cervical fusion, who are smokers, who are diabetic or those who are osteoporotic. because this is a post market prospective study, subjects who are enrolled in this study will be identified by the investigator as needing cervical fusion surgery and asked to participate in a study looking at the efficacy of cervical fusion with adjunctive use of the cervicalstim bone growth simulator. the type of cervical fusion surgery performed is up to the investigator; the subjects in the study must be agreeable to using the bone growth stimulator for 6 months post-surgery. the subjects will be followed for 12 months.

Eligibility criteria:
inclusion criteria: 1. male or female, ≥ 18 years of age at the time of informed consent. 2. requires a cervical fusion surgery within 30 days of informed consent signing. a. surgical approach is at the physician's discretion. 3. subject has one or more high risk factors: 1. is currently using nicotine 2. multi-level cervical fusion surgery planned 3. prior failed fusion at any cervical level 4. subject reported diabetes 5. subject reported osteoporosis 4. body mass index ≤ 45 kg/m2 at the time of consent. 5. must have reliable access to an iphone or an ipad with wi-fi access for downloading the free device-specific app (iphone 5s or higher, ipad, ipad pro, ipad mini or itouch using ios v.9.3 or later). a. when the android version of the mobile app for the cervicalstim device becomes available (estimated to be dec. 2017), subjects who have reliable access to devices using android operating systems will be eligible for study inclusion. 6. able and willing to complete electronic questionnaires and able to read and understand study instructions in english. 7. able and willing to comply with the study plan and able to understand and sign the study-specific informed consent form (icf). exclusion criteria: 1. current alcoholism and/or any known current addiction to pain medications. 2. any active malignancy or prior history of malignancy within last 5 years prior to fusion (except basal cell carcinoma of the skin). 3. any clinically significant finding that places the subject at health risk, impacts the study, or affects completion of the study, in the opinion of the investigator. 4. any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the investigator. 5. subject is a prisoner.

Keywords: degenerative disc disease cervicalstim devic cervical cervical fusion
comparing the efficacy and safety of rosuvastatin with atorvastatin and simvastatin (solar)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to compare the efficacy and safety of rosuvastatin with simvastatin and atorvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia


Eligibility criteria:
inclusion criteria: * member of managed care plan for hypercholesterolemia * fasting blood lipid levels as defined by the protocol * diagnosis of coronary heart disease, diabetes, or atherosclerotic disease, or presence of multiple risk factors giving high risk of coronary heart disease exclusion criteria: * the use of lipid lowering drugs or dietary supplements after visit 1. * active arterial disease eg unstable angina, or recent arterial surgery * blood lipid levels above the limits defined in the protocol. * uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Keywords: cholesterol low density lipoproteins dyslipidaemia rosuvastatin crestor atorvastatin lipitor zocor simvastatin
the roles of mri, dyneelax and stress x-ray in first-line diagnosis of cruciate ligament injury

Conditions: Knee Injuries; Anterior Cruciate Ligament Injuries; Knee Ligament Injury; Knee Arthritis

Summary: background: cruciate ligament tears are clinically diagnosed by detection of anterior or posterior tibial translation on physical examination; however, this manual method of assessment is imprecise, subjective, and not reproducible. recently a new instrument, a stress radiographic device and knee stability test (dyneelax), were produced to objectively measure these displacements. objective: to assess new diagnostic methods, in the measurement of anterior/posterior tibial translation in cruciate ligament-deficient knee compared to the healthy knee. material and method: the mri, stress radiographic device and knee stability test was applied to cruciate ligament-tear knees that were diagnosed by physical examination as having partial or complete cruciate ligament tears. each knee was tested under a force 120 newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. measurement of rotation and translation by dyneelax was also recorded.


Eligibility criteria:
inclusion criteria: patients are diagnoed as acl/pcl injury or suspect ligament sprain at kaohsiung veteran general hospital. exclusion criteria: unable receing mri exam, any op history of knee or fracture history on the impaired knee.
dependence of lv hemodynamics on pacing site

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the effects of epicardial and endocardial pacing at each side of the left ventricular (lv) segments on cardiac hemodynamics in patients with impaired lv function undergoing epicardial ablation and mapping procedure. hemodynamic function will be assessed during a pacing protocol with a pressure catheter inserted in the lv.


Eligibility criteria:
inclusion criteria: * patient is already indicated for epicardial mapping and ablation of arrhythmia(s) utilizing a transcutaneous subxiphoid approach * be in sinus rhythm * have lvef \< 40% * have the ability to provide informed consent for study participation and be willing and able to comply with the cip (clinical investigational plan) described evaluations exclusion criteria: * have permanent af * have pericardial disease * have a recent myocardial infarction within 40 days prior to enrollment * have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures * have had a recent cva or tia within 3 months prior to enrollment * be less than 18 years of age * be pregnant
safety, pharmacokinetics and pharmacodynamics of elbasvir (mk-8742) in hepatitis c infected males (mk-8742-002)

Conditions: Hepatitis, Viral, Human

Summary: the purpose of this study is to assess the safety, pharmacokinetics (pk) and pharmacodynamics of elbasvir (mk-8742) in hepatitis c virus (hcv)-infected participants. there will be 3 parts to this study; part i will enroll only genotype (gt) 1 hcv-infected participants, part ii will enroll gt3 hcv-infected participants, and part iii will enroll only gt1a hcv-infected participants. all parts may run concurrently, or parts ii and iii may be staggered. hypothesis (part i): at a once-daily dose that is sufficiently safe and well tolerated in hcv-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in gt1 hcv-infected participants compared to placebo, as measured by change from baseline in plasma hcv ribonucleic acid (rna; log 10 copies/ml) at day 5, 24-hour postdose timepoint. (a true mean viral rna reduction of at least 3 log10 is anticipated). hypothesis (part ii): at a dose that is sufficiently safe in gt3 hcv-infected participants, the mean maximum reduction in hcv viral load is greater following multiple dose oral administration of elbasvir as compared to placebo. hypothesis (part iii): at a once-daily dose that is sufficiently safe and well tolerated in hcv-infected participants, elbasvir administered for 5 consecutive days has superior antiviral activity in gt1a hcv-infected participants compared to placebo, as measured by change from baseline in plasma hcv rna (log 10 copies/ml) at day 5, 24-hour postdose timepoint. (a true mean viral rna reduction of at least 3 log10 is anticipated).


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18 to ≤ 37 kg/m\^2 * clinical diagnosis of chronic hcv infection defined by positive serology for hcv for at least 6 months and detectable hcv rna in peripheral blood ≥105 iu/ml at screening * participant must be infected with hcv gt1a, gt1b, or gt 3 exclusion criteria: * co-infection with gt1 and gt3 * estimated creatinine clearance of ≤70 ml/min based on the cockcroft-gault equation * history of stroke, chronic seizures, or major neurological disorder * history of clinically significant endocrine, gastrointestinal (excepting hcv infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases * history of neoplastic disease * positive hepatitis b surface antigen at the pre-study (screening) visit * has had major surgery, donated or lost 1 unit of blood (approximately 500 ml) or participated in another investigational study within 4 weeks prior to the prestudy (screening) visit. * previous treatments (s) with nonstructural protein 5a (ns5a) inhibitors * \<4 weeks since administration of any experimental protease inhibitor * previous exposure to interferon-alpha and/or ribavirin within 3 month prior to the first dose of elbasvir in the study * clinical or laboratory evidence of advanced or decompensated liver disease
a clinical study to evaluate efficacy and safety of fimasartan/hydrochlorothiazide combination-therapy

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the antihypertensive efficacy and safety of fimasartan/hydrochlorothiazide combination 60/12.5mg\~120/12.5mg in patients with essential hypertension who are not controlled by fimasartan 60mg.


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 years of age and older * patients with antihypertensive agents at screening: dbp\<110mmhg or patients without antihypertensive agents at screening: dbp 90mmhg\~120mmhg * subjects who agree to participate in this sudy and give written informed consent * subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study * patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, dbp 90mmhg\~109mmhg and sbp\<180mmhg exclusion criteria: * the sitting dbp is more than 120mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg patients with secondary hypertension * patients who are measured the mean difference of mean blood pressure under sidbp 10mmhg or sisbp 20mmhg at screening or baseline visit * patients with severe renal(creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(ast, alt more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug * patients with postural hypotension * patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(hba1c\>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening) * patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months * patients with consumptive disease, autoimmune disease, connective tissue disease * patients with a history of type b or c hepatitis(include carrier) * patients with hiv or hepatitis * patients with clinically significant laboratory abnormality * patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure * patients with allergy or contraindication to any angiotensin ii receptor antagonists * female of childbearing potential who does not undergo hysterectomy or is not post-menopausal * patients judged to have a history of alcohol or drug abuse by the investigator * patients participated other clinical trial 12 weeks before screening - patients judged to be inappropriate for this study by the investigator with other reasons

Keywords: fimasartan fimasartan/hydrochlorothiazide combination