Kornimate/medical-research-clean huggingface dataset:
determining the effect on patients of internet-based diabetes disease management

Conditions: Diabetes Mellitus, Type 2

Summary: this grant supports a 12-month randomized controlled trial comparing usual care versus collaborative disease management over the internet among disadvantaged african-americans with type 2 diabetes. the project aims to: (1) determine the effect of case-managed, web-based diabetes care on glycemic control, health care utilization, self-efficacy, and patient satisfaction; and (2) qualitatively identify enablers of the successful use of computers, the internet, and e-health applications by disadvantaged patients.

we propose to conduct a 12-month randomized controlled trial comparing usual care versus chronic disease management over the internet among disadvantaged african-americans with type 2 diabetes. subjects will be recruited from patients receiving primary care at harborview medical center, the county facility administered by the university of washington in seattle. as part of a pretest-posttest experimental design, 30 intervention subjects will be trained to use an existing diabetes disease-management module comprising six web sites that are accessed from home via links displayed within the university's "myuw" internet portal. these sites allow patients to: 1. view their entire electronic medical record, the same record used by providers, 2. upload blood glucose readings stored in a digital meter, 3. enter medication, nutrition, and exercise information into an online daily diary, 4. communicate with providers regarding treatment recommendations or other questions using clinical e-mail, 5. obtain additional information from a traditional patient education site with endorsed content, and 6. employ a second education site to collaboratively generate action plans intended to enhance self-efficacy. all data can be viewed by patients and providers in online trended displays that a clinical pharmacist will use to review cases no less often than weekly. as an attention control, 30 subjects will also be trained to use a provided personal computer to access internet knowledge resources, but will not have access to the case-management services and module being evaluated. by comparing the two groups, we aim to: 1. determine the effect of case-managed, web-based diabetes care on glycemic control, healthcare utilization, self-efficacy, and patient satisfaction, and 2. use semi-structured interviews among a subsample of both trial arms to qualitatively identify enablers of the successful use of computers, the internet, and e-health applications by disadvantaged patients.

Eligibility criteria:
inclusion criteria: * african american exclusion criteria: * non-english speaking

Keywords: diabetes health education information technology african americans disease management internet patient education
use of tendon vibration and mirror for the improvement of upper limb function and pain reduction

Conditions: Stroke; Hemiplegia

Summary: upper limb paralysis following stroke is a very common problem. only 30% of stroke patients who suffer from upper limb paresis experience a full recovery of function. there is a need for the development of more efficient rehabilitation methods for the improvement of the paralysed upper limb function. it has been shown that the use of mirror therapy after a stroke induces the activation of motor, sensory and associative regions in the affected hemisphere and is associated with an improvement in the function of the affected limb. mirror therapy is a treatment modality in which the affected arm is hidden from the patient's sight; the patient is instructed to watch the reflection of his healthy hand on a mirror while he performs movements with his healthy hand and tries to move simultaneously his affected hand. this induces the illusion that his affected hand moves well. it has also been shown that applying vibration to a muscle tendon at frequencies between 50-100 hz induces an illusion of elongation of the vibrated muscle, if visual feedback is prevented. for instance, vibrating the triceps will induce a strong illusion of elbow flexion. in the present study the investigators will couple the use of a mirror with the application of vibration to tendons, in order to obtain a multisensorial and strong illusion of movement in the paralyzed limb. the study hypothesis is that the administration of mirror therapy together with vibration will induce the activation of multiple motor, sensory and associative areas in the affected brain hemisphere, resulting in improvement of the affected upper limb function, compared to the administration of mirror therapy alone or sham therapy.


Eligibility criteria:
inclusion criteria: * stroke onset 1 month-1 year ago * nih stroke scale 3-15 on admission to study * affected upper limb function 10-90% on fugl-meyer scale * ability to understand instructions and to move freely the unaffected upper limb exclusion criteria: * severe cognitive impairment- severe aphasia or severe neglect that impair ability to understand instructions or to execute tasks
clinical study of hospital-manufactured cd19 car-t in children and adolescents with acute lymphoblastic leukemia

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: chimeric antigen receptor t cells (car-t cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. the purpose of this clinical study is to produce the cd19\[cluster of differentiation antigen 19\] car-t (snuh-cd19-car-t) at the investigational site and to evaluate safety and efficacy of snuh-cd19-car-t in children and adolescent with relapsed/refractory b-cell acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria: * 1. relapsed or refractory cd19 positive acute lymphoblastic leukemia. all subjects must be younger than 26 years old at the time of obtaining informed consent a. 2nd or greater bm\[bone marrow\] relapse or b. any bm relapse after allogeneic sct\[stem cell transplant\] and must be ≥ 6 months from sct at the time of snuh_cd19_car-t infusion or c .refractory as defined by not achieving a cr after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a cr after 1 cycle of standard chemotherapy for relapsed leukemia or d. ineligible for allogeneic sct because of: * severe comorbid disease * other contraindications to allogeneic sct conditioning regimen * lack of suitable donor 2. documentation of cd19 tumor expression in bone marrow or peripheral blood by flow cytometry. 3. karnofsky (age ≥ 16 years) or lansky (age \< 16 years) performance status ≥ 50 at screening exclusion criteria: 1. evidence of uncontrolled hepatitis b virus (hbv) or hepatitis c virus (hcv) based on assessment done by treating physicians. 2. known human immunodeficiency virus (hiv) infection. 3. presence of clinically active uncontrolled infection based on assessment done by treating physicians. infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. persisting fever without other signs or symptoms will not be interpreted as progressing infection. 4. pregnant or nursing (lactating) women.
comparisons of the effects of solifenacin versus mirabegron on autonomic system, arterial stiffness and psychosomatic distress and clinical outcomes

Conditions: Overactive Bladder Syndrome

Summary: background/purpose: the overactive bladder syndrome (oab) affects around 17 % of female population. antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic distress. however, there is no such research for the new drug- mirabegron (a β3-agonist). thus, the aim of our study is to analyze the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups. patients and methods: the investigators will perform a prospective randomized controlled study to recruit 150 female oab patients at the outpatient clinic of department of obstetrics and gynecology of national taiwan university hospital. all oab female patients will be asked to complete urgency severity scales, overactive bladder symptoms scores questionnaires, king's health questionnaires, udi-6 \& iiq-7, patient health questionnaire, brief symptom rating scale (bsrs), maudsley personality inventory (mpi) and adaptability, partnership, growth, affection, and resolve (apgar) questionnaires, sleep and dietary habit questionnaire, standard 12-leads electrocardiography (ecg), 5 minutes holter monitoring, cardio-ankle vascular index (cavi) test, bladder diary, 20-min pad test, urodynamic studies and measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron versus solifenacin treatment. stata software is used for statistical analyses. possible results: the investigators can answer that the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups. the above conclusions should be important for pre-treatment consultation.


Eligibility criteria:
inclusion criteria: * women with overactive bladder syndrome * ≥20 year-old exclusion criteria: * urine retention, * acute angle glaucoma, * myasthenia gravis, * ulcerative colitis, * megacolon
evaluation of peripheral itch mechanisms following injection of morphine (second sub-project)

Conditions: Itch

Summary: the aim of our 2nd sub-project is to clarify if the capsaicin receptor trpv1 is implicated in the mechanism of morphine-induced mast cell degranulation. moreover, we also aim to clarify if the mechanism of opioid-induced itch relay on the histaminergic pathway by using the antihistamine (diphenhydramine) to suppress the release of histamine from peripheral mast cells.


Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results. * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids or other addictive drugs * lack of ability to cooperate * current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers as well as systemic or topical steroids. * participants with known allergy/discomfort to the opioid morphine and antihistamine. * skin diseases * moles, scars or tattoos in the area to be treated or tested. * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
postoperative sleep quality in patients undergoing thoracic surgery with different types of anesthesia management

Conditions: General Anesthesia, Thoracic Epidural Anesthesia

Summary: we designed a study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

we designed a prospective, single-blinded, randomized, and controlled study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

Eligibility criteria:
inclusion criteria: * lung surgery * one-lung ventilation. exclusion criteria: * body mass index exceeding 30 kg/m2, * autonomic dysfunction, * cardiovascular disease, * neurological or psychiatric diseases

Keywords: dexmedetomidine, thoracic epidural anesthesia
prevention of vaso-occlusive painful crisis by using omega-3 fatty acid supplements

Conditions: Sickle Cell Disease

Summary: 140 scd patients \[70 on hydroxyurea\] will receive omega-3 capsules whereas another 140 scd patients \[70 on hydroxyurea\] will receive placebo and will be recruited from the sultan qaboos university hospital \[squh\] haematology specialty clinics. patients will be randomized in a 1:1 ratio to receive placebo or omega-3 for 52 weeks. the aim is to investigate the therapeutic potential of omega-3 fatty acids in the prevention of vaso-occlusive crisis in omani patients with sickle cell disease\[scd\].


Eligibility criteria:
inclusion criteria: * moderate to severe sickle cell disease patients. * patients already receiving hydroxyurea\[hu\] are eligible for the study. * patients able and willing to comply with the procedures in the study protocol. exclusion criteria: * acute episodes (infection, vaso-occlusive crises (voc), acute chest syndrome (acs), stroke, priapism, splenic sequestration) in the past one month before enrolment. * previous stroke, and other co-morbid diseases like essential hypertension, cardiomyopathy and heart failure, diabetes, chronic renal failure. * patients with a history of adverse reaction to omega-3 fatty acid supplementation. * blood transfusion in the previous 3 months.

Keywords: prevention of vaso occlusive painful crisis
humalog® mix50/50(tm) as a treatment for gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: evaluation of the safety and efficacy of humalog® mix50/50tm administered as 3 injections daily to humalog® plus humulin n® insulin administered as 6 separate injections daily in terms of glucose control for women with gestational diabetes.

controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and maternal outcomes. not only must fasting glucose be normalized, but clinical evidence also indicates that controlling postprandial hyperglycemia will significantly reduce the risk of adverse neonatal and maternal outcomes. standard therapy to achieve near-normal glycemia in gestational diabetes involves combining intermediate-acting basal (nph) insulin with rapid-acting insulin (insulin lispro), thereby requiring 6 daily injections. premixed humalog® mix50/50tm has the potential advantage over combination rapid-acting plus nph insulin because it involves fewer injections, and those injections are associated with mealtime. the potential downside to the premixed formulation is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose. this study will evaluate the efficacy and safety of humalog® mix50/50tm compared to that of humalog® plus humulin n® insulin for the treatment of insulin-requiring patients with gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and assessing pregnancy outcomes.

Eligibility criteria:
inclusion criteria: * pregnant and at least 13 weeks gestation * diagnosed with gestational diabetes mellitus * failed diet therapy exclusion criteria: * \<18 years old or over 45 years old * urine dipstick \>2+ protein * blood pressure \>140/80 mmhg * hematocrit \<30% * refusal to take insulin * inability to understand instructions or to consent to participate.

Keywords: gestational diabetes mellitus insulin analogues in pregnancy
metabolomic signature of exogenous ketosis

Conditions: Ketosis

Summary: ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. this is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. however, how ketone supplements impact metabolism is not fully understood but using high throughput analysis techniques that can characterize hundreds to thousands of metabolites in the blood (known as "metabolomics") may allow researchers to discover novel compounds within the body that are altered by ketone supplements. this will improve our understanding of how ketones impact metabolism and guide future research.


Eligibility criteria:
inclusion criteria: * over the age of 18 years * able to fast overnight exclusion criteria: * being a competitive endurance athlete * following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regular consuming ketone supplements * being unable to travel to and from the university * being pregnant or planning to become pregnant during the study * having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease * being unable to read or communicate in english
inspiratory muscle training in pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: pulmonary arterial hypertension is a rare condition characterised by high blood pressure in the lungs and results in breathlessness and reduced exercise capacity for patients. previous research has shown weakness in respiratory muscles in these patients that may contribute towards their symptoms. despite advances in medical therapy, the condition still results in a significant symptom burden. inspiratory muscle training is a non-invasive intervention involving a device that provides resistance to the muscles of inspiration and increases their strength. this study will investigate the benefit of inspiratory muscle training in patients with pulmonary arterial hypertension who are stable on medical therapy for three months. this will be performed as an outpatient and they will then be reviewed following this with assessment of exercise capacity, breathing capacity (spirometry), quality of life, and assessment of neural respiratory drive (the signals from the brain to the muscles controlling breathing). the study will be based at the golden jubilee national hospital and patients will be recruited from outpatients who are already under the care of the scottish pulmonary vascular unit.


Eligibility criteria:
inclusion criteria: * diagnosed by pulmonary hypertension specialist with precapillary pulmonary hypertension * able to give consent * stable on medical therapy for at least 3 months exclusion criteria: * significant contribution to pulmonary hypertension from lung disease * pregnant
statins and cerebral blood flow in subarachnoid hemorrhage (sah)

Conditions: Subarachnoid Hemorrhage

Summary: the primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal sah who are randomized to receive or not receive statins in a blinded design.

we will determine if statin therapy improves cbf in patients with aneurysmal subarachnoid hemorrhage. this improvement, if present, may be due to improved basal cbf, improved autoregulatory function, or a mitigation of large arterial narrowing. the information gain from this study will help us to better understand the mechanism of action of statins. this knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

Eligibility criteria:
inclusion criteria: * age \> 18 * sah from ruptured cerebral aneurysm within 48 hours of admission. * modified fisher grade 2,3,or 4 * planned surgical or endovascular aneurysm repair exclusion criteria: * pregnancy * sah secondary to traumatic or mycotic aneurysms * pre-ictal statin therapy * contraindication to stain therapy * wfns grade 5 * contraindications to map elevation on day 7-10

Keywords: subarachnoid hemorrhage vasospasm cerebral blood flow cerebral metabolism autoregulation statin vasospasm associated with subarachnoid hemorrhage
argus ii/orcam device study

Conditions: Retinitis Pigmentosa

Summary: this study is being done to determine if wearable text-to-speech (tts) and visual pattern recognition (vpr) technology can be used to extend the capabilities of the argus ii to allow patients to read and recognize faces and objects. the argus ii retinal prosthesis can restore rudimentary forms of vision to patients with bare light-perception vision. using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. current limits in the resolution of the device prevent useful reading or face recognition. the fda has approved the argus ii as a humanitarian device. present-day wearable text-to-speech converters are also capable of object and face recognition. such systems have been developed to assist with these tasks in patients with severe low-vision. orcam is a commercially-available eyeglass-mounted visual pattern recognition system capable of converting photographs of text to speech. it is comprised of a camera, a small belt-worn computer, pattern recognition software and a small audio transducer. orcam can acquire the image of a sheet of paper and read the text to the user through a small speaker adjacent to the ear. in addition, orcam can be trained to recognize faces and speak the name of the individual to the user. orcam can also be used to recognize everyday products after being programmed.

the orcam device will be mounted onto the argus ii eyeglasses. the subject will be asked to use the orcam device with and without the argus ii. after a half-day interactive training session with the orcam device, the investigators will interview the subject with a questionnaire. the investigators will then contact the subject every two weeks via a telephone call for two months (4 phone interviews). the investigators will then ask the subject to return to mayo clinic to demonstrate their ability to use the argus ii and orcam together and separately. these sessions will be videotaped.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced retinitis pigmentosa * subjects must have an argus ii device implanted to be eligible for this study * subjects must be familiar with using their argus ii device exclusion criteria: - no argus ii implant
computer-assisted detection of colonic polyps

Conditions: Colon Adenoma

Summary: screening colonoscopy is considered the gold standard for adenoma detection in the colon. however, it has been shown that a considerable number of polyps can be missed during screening colonoscopy. until now the endoscopist himself is responsible for the detection of adenomatous polyps. no automatic tools are available supporting the colonoscopist to detect lesions. recently, a computer program was developed that can be used to recognize and extract suspicious structure from colonoscopy video sequences. the program was built to automatically detected colonic polyps and to highlight the polyps by colour marking. the program was now refined so that the respective structures can be highlighted during real time colonoscopy. the aim of this feasibility study is to test whether the software is applicable during real time colonoscopy.


Eligibility criteria:
inclusion criteria: * indication for colonoscopy * age ≥ 40 years exclusion criteria: * american society of anesthesiologists class iv or higher * pregnant women * indication for colonoscopy: inflammatory bowel disease * indication for colonoscopy: polyposis syndrome * indication for colonoscopy: emergency colonoscopy e.g. acute bleeding

Keywords: adenoma computer automatic polyp detection