Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy of cesamet™ for the treatment of pain in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study was designed to evaluate the safety and efficacy of cesamet™ in controlling pain in subjects experiencing pain due to multiple sclerosis.

the purpose of this study is to determine the safety and efficacy of cesamet™ in the symptomatic treatment of pain due to multiple sclerosis. this is a phase iv, multi-center, open label outpatient clinical trial evaluating cesamet™ treatment for control of pain due ms. the study has two phases: a pretreatment phase and a treatment phase.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ms * chronic daily pain present for at least 2 months. * on stable analgesic regimen for one month * baseline pain score greater than 40mm on a visual analog scale. exclusion criteria: * hypersensitivity to compounds in study drug or similar drugs * pregnant or lactating females * drug or alcohol abuse * unstable medical condition
the impact of school-based intervention for 9-13-year-old school children with overweight and obesity

Conditions: Overweight Children; Obese Children and Adolescents

Summary: childhood obesity is a major issue for the united arab emirates (uae). interventions modifying people's nutritional behavior and changing their dietary habits can potentially address this problem. this study assessed the effectiveness of the 6-month school-based nutritional educational intervention on fruit and vegetable intake, nutrition knowledge, anthropometric measures, and practice, attitude, and self-efficacy measures.

the problem of childhood obesity is a critical issue for the uae. findings of recent studies illustrate that nutritional interventions seeking to modify people's nutritional behavior and change their dietary habits have the potential to address this problem. this article reports the results of the study that was dedicated to the influence of the school-based nutritional educational intervention on fruit and vegetable intake, anthropometric measures, practice, attitude, self-efficacy, and knowledge scores of schoolchildren. the intervention was carried out among 9-13-year-old schoolchildren at public schools from dubai and sharjah (n=403). the sample included three groups, including the control group (n=114), intervention group 1 (n=148), and intervention group 2 (n=141). the control group was exposed to a conventional curriculum on healthy nutrition. group 1 participated in the intervention involving children, and group 2 participated in the intervention involving students, peers, and parents.

Eligibility criteria:
inclusion criteria: * who bmi-for-age growth charts, students with bmi from the 85th to the 95th percentile were categorized as "overweight," and those who were above the 95th percentile were categorized as "obese" * attending government school. * within grades 6-9. * live in dubai or sharjah * female and male students exclusion criteria: * students with bmi below the 85th percentile for the who bmi-for-age growth charts. * not attending a government school * living in another emirate (not dubai or sharjah)

Keywords: overnutrition nutrition disorders body weight overweight schoolchildren peer pressure
caudal epidural injection of dextrose for low back pain

Conditions: Back Pain Lower Back Chronic

Summary: objective: the purposes of the study are to 1. explore the immediate and short term (to 48 hour) analgesic potential of epidural d5w in comparison to normal saline. 2. determine if cumulative benefit results from caudal dextrose injection. 3. evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of d5w.

injection of dextrose into the epidural space as an admixture with various steroids and anesthetic has been utilized for years for purposes of altering the specific gravity of the injectate. no safety issues or concerns have been raised about the dextrose component inclusion but a separate therapeutic effect of dextrose has not heretofore been considered. recently dextrose has been found to treat neurogenic inflammation (pain from upregulation of the trpv1 receptor on peptidergic nerves). an analgesic effect of dextrose on chronic pain in the presence of painful sensory nerves has been observed with injection of d5w without anesthetic. that effect begins within seconds clinically. physicians have empirically trialed d5w for epidural injection in a 10 ml volume and found that marked or complete analgesia of chronic low back and leg pain results in the majority of patients within 15 minutes. an empirical consecutive patient date collection has demonstrated that this initial effect lasts for 2 to 48 hours, and that the effect begins to sustain after 2-3 sessions. for this reason, the current study is designed with the the first two objectives: 1. explore the immediate and short term (to 48 hour) analgesic potential of epidural d5w in comparison to normal saline. 2. determine if cumulative benefit results from caudal dextrose injection. in addition to determining potential benefit from caudal epidural of dextrose, the accuracy of a simple vertical approach to injection of dextrose is to be evaluated. if this vertical approach is accurate it will allow for 1. more comfort with injection. 2. less need for radiographic exposure, in that needle placement is quicker and easier, allowing for less fluoroscopy time. 3. potential for blind injection of solutions that do not include anesthetic or particulate matter, increasing potential applicability of caudal dextrose injection to situations in which fluoroscopy is not available.

Eligibility criteria:
inclusion criteria: * more than 3 months of back pain * some pain below the iliac crest (either in buttock or in leg) * at least one conservative (non-injection) modality of treatment to include physical therapy, chiropractic/osteopathic manipulation, exercises, drug therapy, and relative rest. * opiate use absent or controlled * psychiatric history absent or controlled * current medical stability * absent steroid use history or no allergy or intolerance to steroid use exclusion criteria: * unstable neurologic function

Keywords: caudal epidural dextrose analgesia trvp1
the role of msc in the treatment of fistulas in patients with perianal crohn's disease

Conditions: Crohn's Disease; Fistula

Summary: here investigators will carry out this phase ii clinical trial to explore a effective therapeutic regimen of msc in the crohn's perianal fistula.

peri-anal fistula is common seen in crohn's disease. treatments including surgery, antibiotics, immunosuppressive drug and infliximab improve the quality of life of the patients suffering crohn's perianal fistula, but the recurrent rate is still high. msc showed promising effect in the therapy of cd, but the standard treatment strategy is unclear. here investigators will carry out this phase ii clinical trial to explore a effective therapeutic regimen of msc in the crohn's perianal fistula.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years old, male or female; 2. refractory cd fistula, there are 1-2 and 1-3 in the mouth fistula; 3. diagnostic cd at least three months; 4. cdai \<250; 5. were receiving drug treatment (5-asa and hormones\> 4 weeks, immunosuppressants and biological agents\> 8 weeks); 6. signed informed consent. exclusion criteria: 1. with intestinal obstruction, stenosis, or perianal abscess; 2. pregnant or lactating women; 3. infection needs antibiotics persons; 4. rectovaginal fistula; 5. complex anal fistula more than two inside the mouth; 6. stenosis or perforation cd; 7. perianal infection; 8. could not do rectal or anal stenosis local injection therapy; 9. with acute enteritis; 10. , liver and kidney dysfunction; 11. a month have used other drugs are in clinical trials; 12. no conditions or unwilling to carry out mri inspected; 13. who are adjusting therapy; 14. hiv patients; 15. the combined active hepatitis or tuberculosis; occurred in 16) 6 months opportunistic infections, or severe infections occur within three months; 17) in the past five years, those who suffer from cancer; 18) there is a history of lymphoproliferative disease.
duration and adverse events of non-cuffed catheter in patients with hemodialysis

Conditions: Renal Failure Chronic Requiring Hemodialysis; Central Venous Catheterization; Inadequate Hemodialysis Blood Flow; Venous Stenosis; Venous Thrombosis; Infection Due to Central Venous Catheter; Central Venous Catheter Thrombosis

Summary: the duration and adverse events of non-cuffed catheter in patients with hemodialysis will be investigated by multicenter prospective cohort. totally, 1,400 patients with chronic renal failure requiring hemodialysis will be enrolled. 900 patients will be given right internal jugular catheterization, and the other 500 patients unsuitable for right internal jugular catheterization will receive femoral catheterizations. every patient will be followed-up for six months. during following-up period, the duration time and adverse events of non-cuffed catheter will be recorded in details, including inadequate hemodialysis blood flow, venous stenosis, venous thrombosis, infection, catheter thrombosis and so on. the central vein will be evaluated by ct angiography to identify its stenosis at last visit after 6 months. this multicentre trial will provide evidence to develop guideline for duration time of using non-cuffed catheter.


Eligibility criteria:
inclusion criteria: * chronic renal failure requiring hemodialysis. * no medical history of central vena catheterization. * maintenance hemodialysis after central vena catheterization. * signed informed consent. exclusion criteria: * had been performed central venous puncture or catheterization before. * can not use heparin. * refused to sign the informed consent. * advanced cancer patients. * with or will take arteriovenous fistula surgery in right arm. * other inappropriate situation

Keywords: hemodialysis end-stage kidney disease central venous catheterization digital subtraction angiography
diagnosis of on with or without ms or nmosd

Conditions: Multiple Sclerosis; Neuromyelitis Optica Spectrum Disorder Attack; Neuromyelitis Optica Spectrum Disorder Relapse; Neuromyelitis Optica Spectrum Disorder Progression; Optic Neuritis

Summary: this is both a prospective and retrospective study of patients with a known diagnosis of optic neuritis (on) only, multiple sclerosis (ms) with on, or neuromyelitis spectrum disorder (nmosd) with on. there will be no requirement for blinding (patient or assessor) and data collected with the reflex app will be compared against other data that track optic nerve functional status, such as optical coherence tomography (oct), visual fields (vf), low-contrast sensitivity, mri orbits/brain and visual evoked potentials (vep). patients who have any diagnosis of on, with or without a diagnosis of ms or nmosd and who have had testing using other modalities such as veps, vf, low-contrast sensitivity studies, oct, and mri of brain or orbits will be included as retrospective subjects in the study. in this cohort, rapd assessments will be completed and compared to against the data that has accrued as noted.

the purpose of this research is to gather information on whether using quantitative- or numerical measurements of pupil changes as an alternative to qualitative- or observation based- testing can be done to assess optic nerve dysfunction in on, ms with on, and nmosd with on. one way this is done is through evaluating relative afferent pupillary defect (rapd), which is a clinical sign that is used to detect an injury or defect in the pupil's pathway and this often involves the retina of the eye, which focuses light, and the optic nerve, which sends visual information to the brain. when shining a light into each eye, the eye with rapd shows a slowed response to light, and when the light moves to the normal eye, the pupil of rapd eye will dilate. observational evaluations of rapd are very common in clinical neurology to detect these optic nerve diseases. as technology has advanced, to lessen the observation errors, numerical measurement of rapd is now possible through a web based app called reflex (brightlamp inc., purdue university), which is a fdaapproved class i regulated medical device. in this study, the investigator will compare the results of a participant's app recording to other data that has been collected which also tracks optic nerve function status.

Eligibility criteria:
inclusion criteria: 1. male or female patients ages 18-90 years 2. signed informed consent 3. have been diagnosed with optic neuritis (on) only, ms and on, or nmosd and on 4. have had at least one previous test to track optical nerve function exclusion criteria: 1. are pregnant or nursing 2. are children (age \<18 years) 3. do not have a diagnosis of optic neuritis (on) 4. have a diagnosis of ms or nmosd without a diagnosis of on as well

Keywords: multiple sclerosis ms neuromyelitis optica spectrum disorder nmosd optic neuritis pupillary response rapd rapid afferent pupillary defect
troponin elevation in acute ischemic stroke (trelas)

Conditions: Stroke

Summary: the primary objective of the prospective observational trial trelas (troponin elevation in acute ischemic stroke) is to elucidate the underlying pathomechanism of ctnt elevation in acute ischemic stroke. consecutive patients with acute ischemic stroke admitted to the department of neurology campus benjamin franklin of the university hospital charité will be screened for ctnt elevations suggestive of myocardial infarction (\>0,05 µg/l). patients with increased troponin will undergo diagnostic coronary angiography within 72 hours. diagnostic findings of coronary angiographies taken out in age- and gender-matched patients presenting with nste-acs (non-st-elevation acute coronary syndrome) to the division of cardiology will serve as a control. the primary endpoint of the study will be the occurrence of culprit lesions indicating focal cardiac damage on the basis of an acute cad.

the primary objective of the prospective observational trial trelas (troponin elevation in acute ischemic stroke) is to elucidate the underlying pathomechanism of ctnt elevation in acute ischemic stroke in order to give guidance for clinical practise. all consecutive patients with acute mri- or ct-confirmed ischemic stroke admitting within 72 hours after symptom onset to the department of neurology campus benjamin franklin of the university hospital of the charité will be screened for ctnt elevations suggestive of myocardial infarction (\>0,05 µg/l) on admission and day 2. patients with increased troponin will undergo diagnostic coronary angiography within 72 hours. diagnostic findings of coronary angiographies taken out in age- and gender-matched patients presenting with nste-acs (non-st-elevation acute coronary syndrome) to the division of cardiology will serve as a control. the primary endpoint of the study will be the occurrence of angiographic culprit lesions indicating focal cardiac damage on the basis of an acute cad. secondary endpoints will be the localisation of stroke in the cerebral imaging and ventriculographic findings of wall motion abnormalities suggestive of neurally mediated global cardiac dysfunction.

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke, confirmed by cerebral mri or ct, respectively 2. inclusion within ≤ 72 hours after symptom onset 3. hstroponin t \>0,05 µg/l exclusion criteria: 1. renal insufficiency (creatinine ≥1,2 mg/dl) 2. limited life expectancy or mrs ≥ 4 prior to stroke event leading to hospital admission 3. contraindications for the coronary angiography 4. age \< 18 years 5. pregnancy 6. patient unwilling or unable to give informed consent

Keywords: ischemic stroke troponin elevation transient apical ballooning acute coronary syndrome troponin elevation, culprit lesion on coronary angiogram, troponin elevation and stroke localisation (temporal lobe?)
cost-effectiveness of forced aerobic exercise for stroke rehabilitation

Conditions: Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Summary: the purpose of this study is to investigate whether aerobic exercise improves the participant's ability to recover function in the arm and leg affected by the participant's stroke. the investigators are also calculating the cost effectiveness of the rehabilitation interventions.

the aims of the study are to determine the clinical efficacy and cost-effectiveness of combining aerobic exercise training with upper extremity motor task practice to improve motor recovery following stroke. it is hypothesized that the neurophysiologic impact of aerobic exercise may augment motor recovery associated with motor task practice. to test this hypothesize, 60 individuals with chronic stroke will be recruited to participate in this randomized clinical trial. following screening and informed consent, all participants will undergo an exercise stress test to determine response to maximal exertion. following the stress test, baseline clinical assessments will be obtained to quantify upper extremity function, gait, endurance, and self-reported quality of life. additionally, variables to determine degree of disability will be obtained. individuals will be randomized to one of two interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task practice. the interventions will occur 3 times per week for 8 weeks. outcomes assessing motor function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks, 6-months and 12-months following end of treatment.

Eligibility criteria:
inclusion criteria: 1. ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging, 2. fugl-meyer motor score 19-55 in the involved upper extremity, 3. ambulatory ≥ 20 meters with no more than contact guard assistance, and 4. 18-85 years of age. exclusion criteria: 1. hospitalization for myocardial infarction, heart failure or heart surgery within 3 months, 2. cardiac arrhythmia, 3. hypertrophic cardiomyopathy, 4. severe aortic stenosis, 5. pulmonary embolus, 6. significant contractures, 7. anti-spasticity injection within 3 months of enrollment and 8. other contraindication to exercise

Keywords: stroke aerobic exercise forced exercise repetitive task practice arm function upper extremity
study to evaluate the long term use of treatment with ain457 for uveitis

Conditions: Uveitis

Summary: this study will provide patients who have completed the ain457 phase ii and phase iii clinical trials in non-infectious uveitis continued access to treatment with ain457 while collecting safety data and information on long term clinical use of treatment with ain457.


Eligibility criteria:
inclusion criteria: * patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed * patient is currently enrolled in cain457a2208 or has completed the core and extension study treatment periods in the ongoing ain457 phase iii clinical trial studies (e.g., cain457c2301 and cain457c2301e1) * willingness to discontinue ain457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator exclusion criteria: * need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than ain457 * pregnant or nursing (lactating) women * women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation other protocol-defined inclusion/exclusion criteria may apply

Keywords: quiescent uveitis intermediate uveitis panuveitis posterior uveitis uveitis
longitudinal analysis of mental disorders, psychosocial distress and care needs of patients and their relatives

Conditions: Neoplasm Malignant

Summary: the primary objectives of this prospective observational multicenter study lupe are to assess the prevalence of mental disorders according to the dsm-5 (objective need for psycho-oncological support), psychosocial distress, psycho-oncological care needs and utilization of psycho-oncological support services (subjective need for support) of cancer patients and their relatives during the first months of cancer survivorship stratified by biopsychosocial factors including socioeconomic status. the investigators further aim to identify moderating and mediating as well as associated factors for psychological distress and supportive care needs. lupe will include 2000 adult patients with solid tumor entities and one relative per patient at 4 measurement points from time of diagnosis to follow-up (+18 months) (t1: after diagnosis, t2: 6 month later, t3: 6 month later, t4: 6 month later). the investigators aim to generate a quota sample according to socioeconomic status (ses) that is representative of the german overall population. all participants will receive validated self-report questionnaires. cancer patients will be interviewed using the standardized clinical interview scid-5.


Eligibility criteria:
inclusion criteria: * primary diagnosis of malignant solid tumor * a maximum time period after diagnosis of 4-8 weeks * minimum age of 18 years * cognitive ability to consent to study participation exclusion criteria: * presence of hematological cancers * patients with cancer recurrence

Keywords: psycho-oncology psychological care utilization distress mental disorders neoplasm malignant cancer
implementing virtual reality (vr) to reduce sedation

Conditions: Sedative During Endoscopy

Summary: the study is a prospective pilot patients aged 21 to 65 undergoing screening colonoscopy or diagnostic upper endoscopy. patients are administered minimal sedation (2 mg of versed and 25 mg of fentanyl) and are given virtual reality (vr) goggles to wear for the duration of the procedure. the purpose of this study is to assess the feasibility, effect, and safety of using vr goggles during endoscopic procedures to decrease sedation requirements, enhance patient satisfaction, and reduce recovery time.


Eligibility criteria:
intervention group inclusion criteria: * undergoing screening colonoscopy or diagnostic upper endoscopy for gerd or dyspepsia at nyu langone brooklyn hospital * aged 21 to 65 exclusion criteria: * visual impairments such as blindness which would impair them from watching the entertainment videos. * patients with history of cad, * history of seizures, * history of vertigo, * history of allergy to plastic, * asaii or iii, * patient with active gi bleed, having either melena or hematochezia. control group inclusion criteria: * underwent screening colonoscopy or diagnostic upper endoscopy for gerd or dyspepsia at nyu langone brooklyn hospital * aged 21 to 65 exclusion criteria: * visual impairments such as blindness which would impair them from watching the entertainment videos * patients with history of cad * history of seizures * history of vertigo * history of allergy to plastic * asaii or iii * patient with active gi bleed, having either melena or hematochezia

Keywords: gerd dyspepsia screening colonoscopy diagnostic upper endoscopy gastroesophageal reflux disease