Kornimate/medical-research-clean huggingface dataset:
mrcp: a reliable, non invasive method for staging chronic pancreatitis in pediatrics

Conditions: Healthy Volunteers

Summary: the goal of this research study is to learn more about the pancreas. the investigators want to use magnetic resonance cholangiopancreatography (mrcp) to learn more about the size of a normal pancreas. mrcp is a special kind of mri exam that produces detailed images of the pancreas. the investigators also want to figure out how much fluid the pancreas releases in response to secretin. secretin is a chemical in the body that causes the pancreas to release fluid that helps with digestion. secretin is used during the mrcp (mr-pft) to help identify dysfunction of the pancreas. mr elastography (mre) will be used to measure how hard the pancreas is. mre is a special kind of mri that uses vibrations to image tissue.

introduction/methods: pancreatic fibrosis is the end stage of chronic pancreatitis (cp), which leads to loss of acinar volume and secretory capacity, and ultimately pancreatic insufficiency (pi). cp and congenital pi affect the pediatric population, and are both increasingly recognized in children. pi has serious negative implications on a child's growth and health but, if diagnosed early, pi can be treated, minimizing the detrimental effects of pi. currently, direct pancreatic function testing (pft) via collection of pancreatic fluid is the "gold standard" for diagnosis of pi but it is an invasive testing that may require sedation or general anesthesia. magnetic resonance cholangiopancreatography (mrcp) with secretin administration (mr-pft) and mr elastography (mre) may allow non-invasive, and potentially early diagnosis of cp and pi. currently, however, normative data with which to compare mr-pft and mre results in pediatric patients with suspected cp/pi is not available. aims: the investigators propose to determine the normal range for secreted pancreatic fluid volume in response to secretin administration and determine the normal range for pancreatic parenchymal stiffness in a pediatric population that is not affected by pancreatic disease. to date, the investigators have validated their mrcp technique and have successfully performed both mr-pft and mre in cp patients; however normative data is essential for validation of our non-invasive technique.

Eligibility criteria:
inclusion criteria: 1. subjects between the ages of 6 and 15.9 years. 2. subjects without a documented history of (or suggestive of) pancreatic disease exclusion criteria: 1. history of pancreatic disease, liver disease, intra-abdominal neoplasm, abdominal inflammatory process such as inflammatory bowel disease (ibd), or systemic illness that may affect pancreatic state (e.g. cystic fibrosis). 2. subjects with surgical hardware/implanted devices making them ineligible for mri (e.g. pacemaker or other implanted medical device not approved for mri). 3. subjects who require any form of sedation or general anesthesia for mri. 4. subjects unable to breath-hold for the required 15-20 second imaging sequence. 5. subjects who are pregnant or less than 12 months post-partum.
study of subretinally injected aavb-081 in patients with usher syndrome type ib (ush1b) retinitis pigmentosa

Conditions: Usher Syndrome, Type 1B

Summary: the purpose of the 081-101 study is to evaluate the safety and tolerability of a single subretinal injection of aavb-081 in ush1b patients with retinitis pigmentosa due to a mutation in the myo7a gene. the study will also assess the initial efficacy following aavb-081 administration.


Eligibility criteria:
inclusion criteria: * molecular diagnosis of usb1b due to myo7a mutation * willingness to adhere to protocol per informed consent exclusion criteria: * unwillingness to meet the requirements of the study * participation in a clinical study with an investigation product in the past 6 months * previous participation in another gene therapy trial * any condition that would preclude subretinal surgery * complicating ocular and/or systemic diseases

Keywords: usher syndrome myo7a ush1b retinitis pigmentosa
a study in healthy adults and adult subjects with rheumatoid arthritis to evaluate the safety, tolerability and pharmacokinetics after multiple doses of abt-494

Conditions: Rheumatoid Arthritis

Summary: this is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study in healthy volunteers, multiple dose study in patients with rheumatoid arthritis and multiple dose study in healthy volunteers.

to assess the safety, tolerability and pharmacokinetics of abt-494 in healthy volunteers and in patients with rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: healthy volunteers: * male and female subjects 18 to 55 years of age, inclusive. * subject is judged to be in good general health. rheumatoid arthritis patients: * male and female patients 18 to 75 years of age, inclusive. * subject has a diagnosis of rheumatoid arthritis for at least six months. * subject has been on methotrexate therapy for at least three months and on a stable dose for at least four weeks. exclusion criteria: * history or evidence of active or latent tuberculosis. * history or significant allergic reaction to any drug. * use of known strong cyp3a and cyp2d6 inhibitors and cyp3a inducers within 21 days or within 5 half-lives of the respective medication, whichever is longer. * current or expected need for oral intake of at least 10 mg prednisone per day or equivalent corticosteroid therapy. * history of acute inflammatory joint disease of different origin other than rheumatoid arthritis (rheumatoid arthritis patients).

Keywords: rheumatoid arthritis methotrexate tolerability pharmacokinetics safety tofacitinib
dexamethasone versus dexmedetomidine as adjuvants for nerve blocks

Conditions: Pain, Postoperative; Pain, Acute; Upper Extremity Injury

Summary: when used as perineural (pn) adjuvants to local anesthetics (las), dexamethasone (dx) and dexmedetomidine (dxd) have been well documented to prolong the duration of peripheral nerve blocks. these drugs have important differences in terms of cost and safety profiles. this randomized controlled trial (rct) will compare pn dx and pn dxd for ultrasound-guided infraclavicular brachial plexus blocks (icbs). since analgesic and sensory duration can be influenced by factors different to block, motor block duration is the main outcome. the protocol is designed as an equivalency trial and hypothesize that both drugs result in similar durations. the equivalency margin is set at 3 hrs.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * american society of anesthesiologists classification 1-3 * body mass index between 20 and 35 exclusion criteria: * adults who are unable to give their own consent * pre-existing neuropathy (assessed by history and physical examination) * coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50) * renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) * hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) * allergy to local anesthetics (las) * pregnancy * prior surgery in the infraclavicular region * chronic pain syndromes requiring opioid intake at home

Keywords: nerve block adjuvants dexamethasone dexmedetomidine nerve block duration
promethazine vs. lorazepam for treatment of vertigo

Conditions: Peripheral Vertigo.

Summary: this study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (iv) promethazine and lorazepam for the treatment of peripheral vertigo in emergency department setting.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * background history of positional vertigo exclusion criteria: * unable to provide informed consent * pregnant or possibly pregnant * known allergy to study medications * use of antiemetic agents in the previous 24 hours * evidence of drug-induced vertigo or orthostatic hypotension * central pathologies/central origin for vertigo
percutaneous nephrolithotomy: a registry and database

Conditions: Nephrolithiasis

Summary: kidney stones vary in size from a tiny grain of sand to as large as filling the inside of the kidney. treatment decisions depend on the size, location, and composition of the stone. some kidney stones can be treated with lithotripsy (breaking up stones inside the body with shock waves created outside the body) or ureteroscopy (placing a small telescope up the urine channel to remove the stone). when stones are large in size or in the lower part of the kidney, a percutaneous (making a passage from the back into the kidney) procedure has been found to be the best method to remove the stones safely and efficiently. a passage is made into the back to allow a small telescope to see the stone and break it into fragments for removal. a small catheter is placed at the end of the procedure to allow the kidney to drain. the purpose of this study is to record information about your surgery into a database so we can look at how patients who have had this procedure have done over time. we hope that reporting the outcomes of this surgery will be helpful to urologists and patients in the future. there may be certain factors that can be identified through this study as having better outcomes that may help make future surgeries safer.

patients of iu health physicians urology who have been scheduled to undergo percutaneous removal of one or more kidney stones will be asked to consent to be part of our registry and database for percutaneous procedures. the database contains information about the subjects surgery, such as stone size and location, number of access sites to remove the stone, length of stay in the hospital, secondary procedures, etc. this information is reviewed periodically to look for trends so that physicians may find ways to improve the percutaneous procedure. all information in the database is kept confidential. data is collected at follow-up appointments at one month and one year to see if the subject is still stone free.

Eligibility criteria:
inclusion criteria: * patients of methodist urology in indianapolis, in * male or female patients with upper urinary tract stone disease appropriate for percutaneous removal as determined by a methodist urology physician exclusion criteria: * patients unable to give informed consent * patients with active bleeding diatheses * women who are pregnant or in whom pregnancy status cannot be confirmed

Keywords: kidney stones nephrolithotripsy percutaneous
oral pregabalin effect to the intravenous morphine in multiple fracture ribs

Conditions: Fracture; Rib, Multiple

Summary: determine the effect of using oral pregabalin on the analgesic effects of iv infusion of morphine in patients with multiple fracture ribs.

blunt chest trauma accounts for a significant proportion of debilitating and life-threatening injuries. rib fractures are notoriously painful and can lead to prolonged hospitalization,contribute to the development of pneumonia and respiratory failure, and delay outpatient recovery significantly.flail chest, along with chest wall deformity, the most severe of chest wall injuries, is associated with significant acute morbidity and mortality.flail chest injury has been associated with a high mortality rates historically and up to 16 % more recently. in-patients with physiologic flail visibly apparent paradoxical chest wall motion leads to inefficient respiratory effort and compression of the lung and diminishes the negative intra thoracic pressure essential for the passive movement of air into the bronchial tree. atelectasis leads to increased lung resistance and decreased compliance, making the work of breathing much more difficult. loss of the ability to generate negative intra thoracic pressure with breathing also impairs venous return, a passive process dependent on the negative intra thoracic pressure generated with each breath. in patients without a visible flail segment, i.e., an anatomic or radiologic flail,the physiologic derangements can be similarly destructive.there is mounting evidence that a patient's perception of pain in the early post-injury period is associated with chronic pain development . a recent prospective study of rib fracture patients found that pain and disability at 8 weeks post injury could be predicted by the pain intensity within the first few days after injury . interestingly, the number of fractures and the bilaterality of fractures were not predictive. thus, pain management in the early post-injury setting is likely paramount to obtaining a more favorable recovery. opioids, are traditional first-line therapy for acute rib fracture pain. but because of chronic misuse potential and central desensitization concerns, pain researchers and clinicians are increasingly recommending that opioids be used only in combination with other analgesic modalities such acetaminophen, nonsteroidal anti-inflammatory medication(nsaid), the anticonvulsants gabapentin and pregabalin,and the topical lidocaine patch

Eligibility criteria:
inclusion criteria: * adult patients above 18 years old * asa \[1\] and asa \[2\] * mentally competent and able to give consent for enrollment in the study exclusion criteria: * patient coma scale less than 10 * impaired kidney functions * chronic pain syndromes and patients with chronic opioid use
a dissonance-based obesity intervention

Conditions: Obesity

Summary: this project will examine the feasibility and acceptability of enhanced project health, a dissonance-based obesity intervention, and whether this intervention results in significantly greater reductions in weight and improvements in lifestyle behaviors than an assessment only condition. participants will be young adults enrolled in college.

approximately 34% of college students are overweight/obese. however, few behavioral weight loss (bwl) interventions have been developed for young adults in college. research suggests that standard bwl interventions are not addressing the needs of young adults as they have shown poorer retention rates and weight loss compared to older adults in bwl trials. standard bwl interventions are also time-intensive and are not conducive to inexpensive dissemination. the primary aim of this project is to examine the feasibility and acceptability of enhanced project health, a dissonance-based obesity intervention for young adults enrolled in college. enhanced project health is based on project health, a dissonance-based obesity prevention program, which has been shown to significantly decrease weight gain and future overweight/obesity onset compared to a matched intervention and minimal intervention control condition in young adults. the current intervention was expanded to consist of eight weekly group sessions and to address sleep, in addition to diet and physical activity. the secondary aim is to test the hypothesis that enhanced project health will result in significantly greater reductions in weight and improvements in lifestyle behaviors compared to an assessment only condition.

Eligibility criteria:
inclusion criteria: 1. young adults of ages 18 to 25. 2. enrolled as a college student. 3. body mass index of 25 or more (overweight/obese) based on measured height and weight. exclusion criteria: 1. diagnosis of bulimia nervosa according to dsm-5 criteria. 2. diagnosis of obstructive sleep apnea. 3. participation in interventions for weight loss or disordered eating behaviors. 4. current use of prescription drugs for weight loss or disordered eating behaviors.
effects of non-alcoholic beer in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to investigate the effects of non-alcoholic beer in patients with type 2 diabetes. subjects will be divided into two groups: the control group, where participants will be consuming a bottle of water (330ml) every day for 12 weeks, and the intervention group, where participants will be consuming a bottle of non-alcoholic beer (330ml) for the same period.

this is a parallel, controlled randomized trial. the study will compare the effect of non-alcoholic beer consumption with water, in patients with type 2 diabetes. all patients from both groups will receive a personalized nutritional intervention and will be followed throughout the study by a certified nutritionist.

Eligibility criteria:
inclusion criteria: * men and women diagnosed with type 2 diabetes mellitus, according to the american diabetes association criteria; * ages 40-80 years; * non-smoker; * willing and able to provide written informed consent. exclusion criteria: * changes in oral glycaemic-control medications in the last 3 months; * subjects with hba1c levels under 6.4% or above 10%; * subjects under insulinotherapy; * subjects with triglycerides levels above 4.52 nmol/l(400 mg/dl); * intake of antibiotics in the last 12 weeks; * subjects not willing to avoid drinking beer during the study; * subjects with a diagnosis of any digestive disease including functional bowel disorders such as ibs; * pregnant women or women planning to become pregnant during the study.
post-approval study of new enrolment patients undergoing bilateral treatment with the visumax smile procedure

Conditions: Myopia; Astigmatism

Summary: the objective of the post-approval study (pas) is to assess patient experience of visual symptoms 6 months after bilateral treatment with the visumax smile procedure as measured by a patient questionnaire.

this is a prospective, multicenter, single arm, open-label, observational study of newly enrolled patients undergoing bilateral treatment with the approved smile procedure for the reduction or elimination of myopia with astigmatism. patients complete a self-administered patient questionnaire preoperatively and 6 months postoperatively. each patient's preoperative status is serving as the control for postoperative endpoints.

Eligibility criteria:
inclusion criteria: * eligible for the approved visumax smile procedure according to the professional use information, i.e. * spherical refractive error (in minus cylinder format) from -1.00 d through -10.00 d; * refraction spherical equivalent not greater in magnitude than 10.00 d; * minimum age of 22 years; * documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 d in magnitude. * good candidate for smile based on the surgeon's assessment of medical and ophthalmic health, cognitive function, and physical and social limitations * intended bilateral smile treatment for the correction of myopia with astigmatism (-0.75 to -3.00 d) * both eyes targeted for the full distance manifest spherocylindrical refraction * fluent english in speaking and reading * willingness and ability to return for 6-month postoperative examination * signed informed consent exclusion criteria: * presence of any of the contraindications of the approved smile procedure for the reduction or elimination of myopia with astigmatism, i.e. * a residual stromal bed thickness that is less than 250 microns from the corneal endothelium; * abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration; * ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect); * irregular or unstable (distorted/not clear) corneal mires on central keratometry images; * severe dry eye; * active eye infection or inflammation; * recent herpes eye infection or problems resulting from past infection; * active autoimmune disease or connective tissue disease; * uncontrolled diabetes; * uncontrolled glaucoma. * previous treatment with any form of refractive surgery
ntx wireless patient monitoring system

Conditions: Desaturation; Bradycardia; Tachycardia; Hypertension; Hypotension

Summary: * determine the accuracy of the ntx wireless monitoring system alerts * evaluate patient compliance with wearing device * determine false alarm rates

approximately 150 patients will have wireless monitors attached to their arm. they will have their vital signs filtered through software that generates alerts and records data. the alert engine will produce pager and application based pop-up alerts which will be sent to the research nurse. low and high limit alarms will be set according to the published guidelines (hillman, k. et. al., resuscitation 48(2): 105-10, 2001) and adjusted at will by the response team. during this portion of the study, the following research related procedures will be performed: * begin continuous vital signs monitoring (bp - 1x per hour, 3 lead ecg -continuous, hr - continuous, spo2 - continuous) * pi or co-pi will review each alert that's generated. the clinical significance will be determined and recorded in the study database * record patient's signs and symptoms daily * assess concomitant * assess ae's, saes

Eligibility criteria:
inclusion criteria: * ability to give written informed consent * patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the vanderbilt university medical center round wing * patients must be ≥18 years of age exclusion criteria: * icu patients * female subjects who are pregnant * patients \< 18 years of age * patients that have a contradiction for continuous blood pressure monitoring

Keywords: ntx nihon kohden mobile monitoring monitoring nihon kohden monitoring device remote monitoring wireless
sparc smartphone application for the management of sarcoidosis-associated fatigue

Conditions: Sarcoidosis; Fatigue

Summary: fatigue is a pervasive and disabling symptom in sarcoidosis with limited treatment options. there is a significant association between heightened stress and sarcoidosis-associated fatigue. the proposed project will evaluate the usability/feasibility of a smartphone-based stress management application for the self-management of sarcoidosis-associated stress and fatigue.


Eligibility criteria:
inclusion criteria: * sarcoidosis diagnosis based on established criteria * ≥18 years old * able to speak, hear, and understand english * elevated saf (fas score ≥22) * owns smartphone with current data plan * willingness and ability to use app to engage in breathing awareness meditation (bam) exclusion criteria: * history of psychotic disorder, bipolar disorder, eating disorder, narcolepsy, cancer diagnosis or treatment in past 12 months * positive screening for potential major depression (patient health questionnaire depression scale \[phq-8; α = .86\] score ≥10) * untreated sleep apnea (based on home sleep study testing) * sarcoidosis exacerbation in past 3 months requiring increase in sarcoidosis medications * \>2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups) * active substance abuse or binge drinking (\>21 drinks/week )