Kornimate/medical-research-clean huggingface dataset:
pilot study: a randomized trial of anesthetic agents for intravitreal injection

Conditions: Macular Degeneration

Summary: this study is designed to compare four currently used types of anesthesia used prior to intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.

over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. injected agents include steroid, antibiotics, and most recently anti-vegf agents. there are many methods of preparing a patient for intravitreal injection. while there are guidelines for infection prophylaxis, there is currently no standard of care or consensus on which method of anesthesia is most effective in reducing pain and discomfort associated with intravitreal injections. patients who have received prior injections and are scheduled to continue regular injections will be randomized to utilize one of four types of anesthetic treatment for each of 4 treatment periods,so that each subject receives all four types of anesthesia over the course of the study. the order of the anesthetic treatment the subject will receive prior to each planned intravitreal injection during the study period will be different for each subject. this will decrease the effect of extraneous variables from influencing subjective pain scores. following each procedure, patients will fill out an analog pain scale questionnaire, grading the discomfort of receiving both the anesthesia and the injection(on separate 0-10 scales). the anesthetic methods used will include: 1.) drops of proparacaine on the eye, 2.) drops of tetracaine on the eye, 3.) a cotton sponge (pledget) soaked with lidocaine 4% placed over the conjunctiva and 4.)a subconjunctival injection with 2% lidocaine. the subjects' number and type of visits, tests and treatments will be standard of care and will not be different due to the study. the total time for the treatment part of the study coincides with four injections (1 injection per month) or approximately 4 months and will be followed for up to 6 months.

Eligibility criteria:
inclusion criteria: * male or female \> 40 years of age * diagnosis of age-related macular degeneration * history of at least 1 intravitreal injection in the past in either eye * written informed consent has been obtained exclusion criteria: * known allergy or sensitivity to the study medications(s), it's components, or other agents required for the study procedures(e.g. povidone iodine)

Keywords: macular degeneration intravitreal injections eye anesthesia-topical/subconjunctival eye-surgical procedures ophthalmologic anesthesia methods
phase ii clinical trial of ops-2071 in the treatment of irritable bowel syndrome of diarrhea type

Conditions: Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

Summary: this is a a multicenter, randomized, double-blind, placebo-controlled, clinical trial to evaluate the efficacy and safety of different doses of ops-2071 in the treatment of irritable bowel syndrome of diarrhea type (ibs-d).the trial is mainly divided into three periods: screening period, treatment period and follow-up period.

screening period: after signing the informed consent form, subjects entered a 14-day screening period to evaluate inclusion/exclusion criteria and collect demographic information, medical history, etc. subject's previous medication should be eluted and concomitant medications should be prohibited. treatment period: after the screening period, subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned (1:1:1:1) to four treatment groups to receive a 2-week treatment period. weekly follow-up and relevant examinations will be performed. follow-up period: the safety follow-up visit will be conducted by telephone on day14 (+2) after the last dose.

Eligibility criteria:
inclusion criteria: 1. subjects who are able to fully understand and willing to comply with the trial procedures, and voluntarily participate in the trial and sign the informed consent form; 2. subjects aged 18 to 65 years at the time of icf signing; 3. subjects who meet rome iv diagnostic criteria for ibs-d; 4. the following criteria should be met during the screening period: exclusion criteria: 1. subjects who have gastrointestinal alarm symptoms within 14 days before screening, such as hematochezia, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, unexplained body mass loss, and nocturnal diarrhea; 2. subjects with previously confirmed diagnosis of digestive organic diseases, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (except for polyps ≤ 0. 3 cm or polypectomy time ≥ 15 days), intestinal diverticulum, intestinal tumor, etc., or patients still complicated with peptic ulcer and infectious diarrhea; 3. subjects with previously confirmed diagnosis of diseases affecting digestive system function, such as uncontrolled hyperthyroidism or hypothyroidism, chronic renal failure, autoimmune diseases, diabetes, and neurological (such as anorexia nervosa) or serious psychiatric system diseases (such as major depression or severe anxiety); 4. subjects with previously confirmed diagnosis of diseases with symptoms similar to ibs, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.; 5. subjects with previously confirmed diagnosis of non-intestinal digestive diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.;
mind your heart-ii

Conditions: Heart Failure; Cognitive Impairment

Summary: this projects studies the role of mindfulness training (mt) to improve self-care among patients with heart failure and cognitive impairment.

stable outpatients patients with co-morbid heart failure (hf) and mild cognitive impairment (mci) (n=176) will be randomly assigned to phone-delivered mt (a weekly, 30-minute session for 8 weeks integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (euc) or to euc alone. per current recommendations, usual care will be enhanced in both groups with self-care education materials. at baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and hf biomarkers. this study has the following objectives: 1. to study the role of mt in improving cognitive function and hf self-care in patients with co-morbid hf and mci. we hypothesize: 1a) cognitive function will improve in mt vs. euc at end of treatment (3 months); 1b) improvements in cognitive function at end of treatment will mediate effects on self-care and hf biomarkers at follow-up (9 months since baseline). 2. to study the role of mt in improving interoceptive awareness and hf self-care in patients with co-morbid hf and mci. we hypothesize: 2a) interoceptive awareness will improve in mt vs. euc at 3 months, and 2b) changes in interoceptive awareness at end of treatment will mediate improvements in self-care and hf biomarkers at 9 months follow-up. 3. to study the mechanistic pathway linking mt, vagal control and cognitive function. we hypothesize: 3a) vagal control will improve in mt vs. euc at end of treatment (3 months); 3b) changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * a documented diagnosis of hf * access to a telephone * mild cognitive impairment (moca score \< = 26) * ability to understand and speak english or spanish exclusion criteria: * unwillingness/inability to provide informed consent * reversible causes of hf (e.g., takotsubo syndrome; myocarditis) * severe hearing impairment not allowing phone delivery * suicidal ideation or plan * current (at least once a month) mind/body practice * planning to move out of the area during the study period * severe cognitive impairment (moca scores \< 15) * new york heart association (nyha) class iv heart failure or clinically unstable * ongoing psychiatric or neurologic conditions * current enrollment in another study
acupuncture and gonadotropin-releasing hormone pulse generator and stress axis in polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: hypothesis the overall hypothesis is that non-obese (bmi \<30) women with pcos have high luteinising hormone (lh) and cortisol pulse frequency and amplitude and that repeated low-frequency ea restore these alterations and induce ovulation.

aim 1. elucidate if low-frequency ea induce ovulation and restore lh frequency and amplitude as well as sex steroid secretion as compared to a control group receiving same amount of attention. aim 2. elucidate if low-frequency ea restore cortisol frequency and amplitude compared to a control group receiving same amount of attention. aim 3. elucidate if low-frequency ea restore psychological distress and quality of life as compared to a control group receiving same amount of attention.in women with pcos.

Eligibility criteria:
inclusion criteria: * 18 - 39 years, inclusive * 30 ≤ bmi * history of irregular menstrual cycles * clinical and/or biochemical androgen excess (determined during screening) exclusion criteria: medical exclusion criteria * history or clinical manifestation of; cardiovascular disease, diabetes (type 1 or type 2), any other significant endocrine or metabolic disorder. * regular use of medications for weight control, psychosis and thyroid disease. a 3 month washout period will be permitted for contraceptives. psychiatric and behavioral exclusion criteria * pregnant or breast-feeding women

Keywords: luteinizing hormone cortisol hpa axis hpo axis ovulation heart rate variability psychological distress and quality of life
web-based education for diabetes patients on adaptable insulin schedules

Conditions: Diabetes

Summary: inclusion criteria: adult diabetes patients on multiple daily insulin injections or using an insulin pump; internet users exclusion criteria: having a severe mental illness patients will be recruited during the conventional consult. if they want to participate, they will get detailed information regarding the study; after giving consent; they will sign the informed consent form and they will get a unique study number. the patient will than complete a questionnaire on a secured website (https://) using the unique study number. after completing this questionnaire, the patient will be randomised either into a group 'standard care + direct start with web-based diabetes education' (intervention group) or they will enter into the other group (control) receiving standard care. three months after the start of the study, all patients will be asked to complete the questionnaire again and the patients into the control group will also get access to 'standard care + web-based diabetes education'. the questionnaire will have to be completed on months 6, year 1 and year 2. at the time of completing the questionnaire, hba1c will be determined. this is part of the routine examination in each participating hospital (uzgent and az nikolaas). the determination of hba1c is not study-specific but the value will be taken into the study. the web-based questionnaire: patients will enter on a website including general study-information. they also have to explicitly click a button to proceed to the questionnaire. after clicking on 'i am prepared to participate in the study' they will see a second webpage retrieving some general information. after receiving this real basic information; they will be redirected to a secure website (https://) and will make use of a unique study number. only the main researcher will have the possibility to link the general information to the unique study number. the informed consent form: the patient will be asked for added information. he/she will have to sign specific pages giving explicitly informed consent for information retrieved from the 'mutualiteit' (national health service - nhs). on the nhs information will be asked regarding the health costs. these figures should make it possible to have a more objective figure of the costs associated to diabetes (care). the patient can stop on every moment the study participation. once decided he/she wants to stop, he/she will receive standard care. study hypotheses: the qol will improve by the use of web-based diabetes education; there will be a reduction in costs using web-based diabetes education; there will be at least an equal-stay or improvement of the hba1c while using web-based diabetes education.


Eligibility criteria:
inclusion criteria: * adult diabetes patients on multiple daily insulin injections or using an insulin pump; * internet users exclusion criteria: * having a severe mental illness

Keywords: patients adaptable insulin schemes
safety and effectiveness of wavefront-guided lasik for the correction of mixed astigmatism

Conditions: Astigmatism

Summary: to demonstrate that wavefront-guided lasik with measurements from idesign is safe and effective in the treatment of mixed astigmatism.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of pre-operative exam * best spectacle corrected visual acuity (bscva) of 20/20 or better * demonstration of refractive stability * anticipated post-operative stromal bed thickness of at lest 250 microns * willing and capable of returning for follow-up examinations for the duration of the study exclusion criteria: * women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study * concurrent use of topical or systemic medications that may impair healing * history of any medical conditions that could affect wound healing * history of prior intraocular or corneal surgery, active ophthalmic disease,or other ocular abnormality * evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) * known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Keywords: astigmatism refractive error lasik
quality of life in multiple myeloma patients treated with bortezomib

Conditions: Multiple Myeloma

Summary: this observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using eortc-qlq c30 (european organization for research and treatment of cancer quality of life questionnaire-core30) and eq-5d (euroqol-5 dimensions). both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.

many clinical studies for the treatment of multiple myeloma have been conducted in korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma. most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited. this study will observe the degree of change in the quality of life in patients with multiple myeloma before and after bortezomib administration by using eortc-c30 (european organization for research and treatment of cancer quality of life questionnaire-core30) and eq-5d (euroqol-5 dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.. observational study - no investigational drug administered

Eligibility criteria:
inclusion criteria: * patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma * patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included exclusion criteria: * patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity * patients with severe hepatic impairment * pregnant women

Keywords: velcade qol proteasome inhibitor bortezomib eortc qlq c30 eq 5d
kineflex artificial disc system to treat degenerative disc disease (ddd)

Conditions: Degenerative Disc Disease

Summary: the kineflex spinal system is no worse than the charite spinal system in patients with single level degenerative disc disease at l4/5 or l5/s1.

the kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (ccm) end-plates and a fully articulating ccm core. the system is available in 3 foot print sizes.

Eligibility criteria:
inclusion criteria summary: * be between 18 and 60 years of age * have evidence of degenerative disc disease (ddd) * history of back and/or radicular pain which is severe, ongoing and recurrent * minimum 6 month period of prior conservative care * moderate oswestry disability index score * moderate pain score * be likely to return for all follow-up visits * be willing and able to provide informed consent for study participation. exclusion criteria summary: * any back or leg pain of unknown origin * foot drop * previous trauma to the study treatment level with compression or bursting * previous retroperitoneal surgery * other spinal surgery at affected level except idet, laminotomy * previous thoracic or lumbar fusion * documented abnormal abdominal vessel or muscular/fascial pathology or morphology * degenerative spondylolisthesis * ischemic (spondylolytic) spondylolisthesis * spondylitis * documented significant spinal, foraminal or lateral stenosis * severely reduced disc space height * documented presence of free nuclear fragment * extensive facet arthritis or degeneration of the facets at any level noted on mri, ct or x-ray * scoliosis of the lumbar spine * metabolic bone disease * active systemic infection * hepatitis * active malignancy or history of metastatic malignancy * any terminal or autoimmune disease * any other disease, condition or surgery which might impair healing * recent history of chemical or alcohol dependence * current or extended use of any drug known to interfere with bone or soft tissue healing * known metal allergy * morbid obesity * transitional vertebrae at level to be treated that has not clearly fused * currently a prisoner * currently involved in spinal litigation * currently experiencing an episode of major mental illness * pregnancy at time of enrollment, since this would contraindicate abdominal surgery * participation in another drug, diologic or medical trial within 30 days of study surgery * lives more than 300 miles from a study center or participation in any other investigational drug, biologic or medical device study.
comparison between foresee home and optical coherence tomography (oct) visual field defects in patients with choroidal neovascularization (cnv)

Conditions: Age Related Macular Degeneration

Summary: the foresee home is used in the recent years to detect age-related macular degeneration (amd) lesions. the device is capable of differentiation as to stages of amd and early detection of changes including choroidal neovascularization (cnv). the foresee home demonstrates a high level of sensitivity and specificity as to the different stages of amd including newly diagnosed or early detection of cnv. the oct may be use as well to identify choroidal neovascularization (cnv). comparison between the two methods will allow better understanding of both devices. the foresee home can use as an assessment tool for the progression and success of the treatment given to amd lesions. therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.


Eligibility criteria:
inclusion criteria: * capable and willing to sign a consent form and participate in the study * subjects diagnosed with cnv * did not perform more then 4 anti- vgef injections * va with habitual correction better then 6/45 in the study eye * ability to understand instructions * familiar with computer usage exclusion criteria: * evidence of macular disease other than amd or glaucoma in the study eye * presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, * any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye * participation in another study with the exclusion of areds study

Keywords: hmp cnv amd php hphp foresee home
optical coherence tomography and optic neuritis (octon)

Conditions: Optical Neuritis

Summary: optic neuritis (on) can remain isolated or reveal a widespread and chronic disease of the central nervous system (cns), a multiple sclerosis (ms) or, more rarely, a devic's neuromyelitis optica (nmo) or a systemic disease. the optical coherence tomography (oct) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µm. costello et al have shown that approximately 75% of 54 ms patients have developed within 3 to 6 months after a on a loss of 10 to 40 µm in the thickness of the peripapillary retinal nerve fiber layer (rnfl). the etiologic diagnosis of on has been transformed in recent years. ms can now be diagnosed by mcdonald's mri criteria and nmo by the aqp4 antibodies (anti-aquaporin- 4) antibodies and the anti-mog (myelin-oligodendrocyte glycoprotein) antibodies. the diagnosis and prognosis value of the oct in patients with on is not well known


Eligibility criteria:
inclusion criteria: * first onset of an optical neuritis lasting for less than 3 months exclusion criteria: * contra-indication to mri * patient opposed to participation in the study * pregnant or lactating woman * patient under a measure of legal protection * absence of affiliation to social security or universal health coverage (cmu)

Keywords: first onset of optical neuritis