Kornimate/medical-research-clean huggingface dataset:
evaluation of stargraft av for hemodialysis access

Conditions: End Stage Renal Disease

Summary: this study is a first-in-human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the healionics stargraft av hemodialysis access graft. the stargraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis. performance of the stargraft av will be compared against control implants of commercially available standard eptfe grafts approved for the same use. the study is enrolling patients with end stage renal disease (esrd) requiring hemodialysis via a prosthetic vascular graft. the study proposes to: 1. demonstrate improved primary patency of the investigational stargraft av compared to the eptfe controls over a period of 6 months, with extended results to 1 year. 2. verify safety of the stargraft av multilayer construction in extended vascular access use. it is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.


Eligibility criteria:
inclusion criteria: 1. male or female, \> 18 years or age. 2. patient has given informed consent to participate in the trial. 3. stated willingness to comply with all study procedures and availability for the duration of the study. 4. able to effectively communicate with study personnel. 5. candidate for a new arterio-venous graft placed in the upper arm. 6. life expectancy judged to be at least 2 years. 7. axillary vein of greater than or equal to 7 mm in diameter. 8. brachial artery of greater than or equal to 4 mm in diameter. 9. systolic blood pressure equal to or greater than 120 mmhg. 10. absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or angiogram. exclusion criteria: 1. unable or unlikely to comply with trial protocol and/or follow-up. 2. pregnancy. 3. clinical morbid obesity. 4. anatomical limitations. 5. immunodeficiency syndrome. 6. history of bacterial infection within 8 weeks prior to graft implantation. 7. history of hypercoagulation or bleeding disorders. 8. elevated platelet count \> 1 million per microliter of blood. 9. history of heparin-induced thrombocytopenia syndrome (hit). 10. medically confirmed stenosis of the veins downstream of the implant site. 11. inadequate arterial flow or pressure proximal to the implant site. 12. currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. 13. fever greater than 38° c. 14. prior allergic reaction to silicone.

Keywords: hemodialysis vascular access arterio-venous grafts (avg)
comparative evaluation of the results of facet joint injections

Conditions: Low Back Pain, Mechanical; Facet Syndrome of Lumbar Spine

Summary: low back pain affects 60 to 90% of the total population. it is one of the most common causes of disability in adults. low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. it is thought that 21 to 41% of low back pain originates from the facet joint. a wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. however, there is still no consensus on the most effective treatment method. with appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. after goldthwait defined the facet joint concept in 1911, ghormley defined facet joint syndrome in 1933. the source of pain in 40-50% of patients is the lumbar facet joints. innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. in 1975, shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. these methods have been further developed over time. the results of facet joint injections are satisfactory in well-selected patient groups. it has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. in this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the physical therapy and rehabilitation hospital in terms of patient pain scores, application time, effort spent and patient anxiety. intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location.


Eligibility criteria:
inclusion criteria: * patients with facet joint syndrome diagnosis exclusion criteria: * pregnant patients * breastfeeding patients * patients with cardiac pacemaker

Keywords: facet joint syndrome low back pain fluoroscopy ultrasound
the treatment effect of chinese herbal compound ointment on atrophic vaginitis

Conditions: Atrophic Vaginitis

Summary: objective：to evaluate the effect and safety of the traditional chinese medicine oil agent on senile atrophic compared as compared to estriol cream in aged woman. design: a randomized double-blind controlled trial. setting: the hospital ward. participants: 200 postmenopausal woman with senile vaginitis (mean age 56). intervention: the traditional chinese medicine oil and estriol cream were separately intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1 month. measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall, vaginal discharge, and ph changes.

80 postmenopausal women living in the communities near the hospital with av (atrophic vaginitis) symptoms were recruited for this clinical trial. patients with av receiving external treatment and requiring hospitalization were randomized in a double-blind, single-centre trial. subjects received chco (chinese herbal compound ointment) topical vaginal application in experimental group, while estriol in control group. the dosage of medicine for single treatment once a day in two group is 0.5g.the total time for therapy is 3 weeks in two groups. assessment indicators：vagine ph, siga and il-1βchanges, the degree of symptoms improving, onset time, edema-size of vaginal wall, vaginal discharge, and relapses and retreatment effect.

Eligibility criteria:
inclusion criteria: * postmenopausal women * with typical clinical manifestations: virginal genital itching or burning sense, increased vaginal secretions, a yellow, a serious bloody pus-like leucorrhea, or sexual intercourse pain * gynecological examination: vaginal epithelium atrophy，vaginal folds flat or disappear， mucosal hyperemia， superficial ulceration * both alt and ast are normal or less than 2 times, bilirubin is normal * serum creatinine level is within the normal range * ecg is normal; exclusion criteria: * gynecological and breast oncology, endometrial hyperplasia(≥5mm) * estrogenic drugs or probiotics used in four week * participate in other clinical trials;thrombotic diseases * abnormal vaginal bleeding without clear diagnose * estriol allergy * severe pneumonia, tuberculosis, lung abscess, myocarditis * heart,liver or kidney failure(nyha class iii-iv,alt to ast ratio twice more than upper limit of normal * sexually transmitted diseases;mental disorders
flaxseed intervention study to assess sex hormone levels among post-menopausal women

Conditions: Healthy

Summary: the purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. this study will address the first steps toward the development of possible breast cancer prevention strategies. differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).

primary objectives: i. evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(oh)-/16-oh-estrone ratio, shbg, testosterone, 2-meoh-e1\&-e2, 4-meoh-e1\&-e2) thought to be involved in the development of breast cancer. secondary objectives: ii. assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels. iii. describe adherence to the flaxseed intervention. outline: participants are randomized to 1 of 2 arms. arm 1: participants take 2 tablespoons of ground flaxseed daily for approximately 50 days. arm 2: participants maintain their usual diet for approximately 50 days. all participants will complete a questionnaire and have their blood drawn at the beginning of the study (day 0) and at the end of the study period (approximately day 50).

Eligibility criteria:
inclusion criteria: 1. women residing in toronto aged 57-64 years old, and post-menopausal. exclusion criteria: 1. consumers of flaxseed and soy (including supplements) in the past 6 months. 2. consumers of sesame oil and sesame seeds in the past 6 months. 3. women who took antibiotics orally in the past 6 months. 4. women who took hormone replacement therapy or corticosteroids in the past month. 5. non-english speaking. 6. current chronic illnesses such as bowel disease (e.g. ibs - irritable bowel syndrome, or ibd - inflammatory bowel disease, such as crohn's or ulcerative colitis), diabetes, heart disease (e.g. high cholesterol or high blood pressure and on medication for it), cancer, or another chronic illness. 7. women who are currently taking blood thinners, such as warfarin.

Keywords: flaxseed postmenopause hormones lignans no evidence of disease
mindful-obot: effect of mindfulness on opioid use and anxiety during primary care buprenorphine treatment

Conditions: Opioid-use Disorder; Anxiety; Depression; Stress Related Disorder

Summary: the goal of this pilot study is to test the mindful recovery obot care continuum (m-rocc) model in primary care office-based opioid treatment (obot). m-rocc features integration of evidence-based mindfulness training with weekly group-based opioid treatment. primary outcomes include (1) feasibility measured by implementation of the curriculum into two cha primary care sites and attendance at weekly sessions; (2) acceptance via self-report and qualitative interviews. secondary outcomes include anxiety reduction.

the primary objective of this study is to conduct a single-arm pilot study in order to refine a mindfulness-based intervention for the opioid use disorder (oud) treatment in primary care, called the mindful recovery oud care continuum (m-rocc). study investigators will conduct qualitative interviews, assess opioid use, preliminary pre/post measures for participants participating in the pilot study. additional aims of the pilot study is manual refinement and pilot testing assessment batteries to prepare for a multi-site rct. the study will focus on demonstrating feasibility and acceptability of the m-rocc continuum.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. current cha patient with a cha primary care provider 3. diagnosis of opioid use disorder prescribed buprenorphine/naloxone 4. sufficient english fluency to understand procedures and questionnaires 5. \<90 days of complete abstinence from illicit opioids, cocaine, benzodiazepines, and alcohol (excluding cannabis/nicotine) 6. ability to provide informed consent. exclusion criteria: 1. psychosis 2. mania 3. thought disorder 4. schizophrenia or schizoaffective disorder 5. acute suicidality with plan 6. cognitive inability as demonstrated by montreal cognitive assessment (moca) \<24 or the inability to complete consent quiz and baseline assessments. 7. current participation in another cha research study 8. expected hospitalization in next 6 months, including second and third trimester pregnancy at screening.
the effect of aromatherapy on cognitive functions, anxiety and sleep

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to determine the effect of aromatherapy application on cognitive functions, anxiety and sleep quality in elderly people with diabetes.

in addition to its physiological complications, diabetes is a disease that has negative effects on cognitive functions and is accompanied by anxiety and sleep problems. these problems negatively affect diabetes management and glycemic control. ensuring glycemic control is the most important goal of diabetes treatment. the chronic and progressive nature of diabetes, the continuous increase in the number of individuals with diabetes and the accompanying problems lead the individual to seek alternative treatment methods in addition to clinical medical treatment. when the literature is examined, it is seen that aromatherapy is used in many clinical applications. studies have shown the positive effects of lavender and rosemary and aromatherapy on cognitive functions, anxiety and sleep problems. however, no comprehensive studies on its effects in the elderly with diabetes were found. this study was planned to determine the effect of aromatherapy application on cognitive functions, anxiety and sleep quality in elderly people with diabetes.

Eligibility criteria:
inclusion criteria: * who agreed to participate in the research * those aged 65 and over * diagnosed with diabetes for at least 1 year * having no problems with hearing, speaking, seeing and smelling in a way that hinders communication * those who have no problem in verbal communication * passing the sense of smell test * not taking current anxiolytic or hypnotic therapy * not diagnosed with a psychiatric illness and without a diagnosis of mental disability * do not have any respiratory system disease such as asthma, copd and allergic skin disease * no diagnosis of epilepsy disease * no known allergy to essential oils to be used in the application * those who did not use any of the other complementary and integrative application methods at the time of the study. * not using sleeping pills exclusion criteria: * failure to make interventions within the specified time * not attending one of the sessions * unwillingness to cooperate with the study * in addition to existing diseases, respiratory system diseases such as asthma, copd and allergic diseases * known allergy to essential oils and oil used in the study. * failed to pass the sense of smell test. * receiving anxiolytic or hypnotic therapy * those with a diagnosis of psychiatric illness * those with a diagnosis of epilepsy disease * speech, hearing and vision loss * those who do not agree to participate in the research * living alone

Keywords: diabetes aromatherapy elderly anxiety cognitive function sleep
pilot feasibility study for hypopals, a mobile health program for improving hypoglycemia management.

Conditions: Type 1 Diabetes; Hypoglycemia

Summary: a mobile health program "hypopals", which incorporates data from continuous glucose monitoring systems (cgms) and sends personalized text messages to help people sharpen their low blood sugar symptom detection skills, and help people consider how they think of low blood sugar, was devised. the goal of the current study is to make sure that hypopals runs smoothly, users find the intervention useful, and the way the researchers conduct the final study will be correct (i.e., there is a need for 'pilot testing' the developed technology and research methods). all participants will receive basic hypoglycemia education text messages, and then be randomized to one of the four experimental conditions: hypoglycemia symptom detection training, education plus, both symptom detection training and education plus, and usual care. participants may receive additional interventional text messages based on the experimental condition participants are assigned to. the study may terminate after collecting sufficient data to evaluate the primary outcome (i.e., determining the number of participants recruited to reach 20 participants who complete the intervention).


Eligibility criteria:
inclusion criteria: * signed and dated informed consent form * self-reported diagnosis of type 1 diabetes for at least 5 years * previous attendance of structured diabetes education program * using cgm greater or equal to (≥1) year * ongoing dexcom cgm use time ≥70% based on cgm report at screening * have had experienced ≥1 episode of severe hypoglycemia in the past year while using cgms or spending ≥1% of time in level 2 hypoglycemia at the time of pre-screening * using cellphone with functionality for sharing real-time data to dexcom clarity and receiving text messages * be able to communicate in english (spoken and written) * willing to comply with all study procedures including sharing cgm glucose information, receiving and reading intervention text messages, and completing study questionnaires exclusion criteria: * active participation in clinical trials on diabetes/hypoglycemia interventions * pregnancy or planning for pregnancy within a year * untreated adrenal insufficiency or hypothyroidism * uncontrolled mental disorder or chronic cognitive dysfunctions (include but not limited to uncontrolled schizophrenia, depression and bipolar disorders; learning disability; active alcohol and substance dependence; dementia or cognitive impairment independent of hypoglycemia)

Keywords: hypoglycemia mobile health technology text messaging
decreasing the invasiveness of ultrasound guided caudal block: a comparison between 22-gauge and 27-guage needles

Conditions: Anesthesia; Pain; Caudal Block; Pediatric Anesthesia; Abdominal Surgeries

Summary: ultrasound (us) has facilitated the use of caudal block in children and visualization of the needle during insertion. this prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the us signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

ultrasound (us) has facilitated the use of caudal block in children, allowing an initial assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to the dural sac ending. real-time us allows visualization of the needle during insertion to reach the dural sac, and to see the turbulence and distention of the layers during injection of the local anesthetic drug. this prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the us signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.

Eligibility criteria:
inclusion criteria: * age between 6 months and 36 months * undergoing elective lower abdominal or perineal surgeries exclusion criteria: * refusal of the legal guardian of the patient. * patients aging less than 6 months, or older than 36 months. * emergency surgeries. * coagulopathy. * infection at the site of procedure. * uncorrected hypovolemia. * increased intracranial pressure. * congenital anomalies at the site of procedure.

Keywords: caudal block ultrasound pediatric anesthesia pain
intra-discal steroid injection for modic i discopathy

Conditions: Back Pain Lower Back Chronic

Summary: to assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging. hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy

objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and modic i discopathy on mri methods: a multicenter double blind randomized control trial setting: 3 tertiary care hospitals in france patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and modic i (inflammatory) discopathy on mri intervention: injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) outcome measures: the primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. success is defined as less than 40 on pain numeric scale at 1 month. secondary outcome measures are pain level at 12 months, disability (quebec questionnaire), quality of life (sf-12) at 1 and 12 months, anxiety and depression (had), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on mri) at 12 months. tolerance and adverse effects will be recorded. trial duration: 36 months(24 months for inclusion and 12 months follow-up) follow-up visits: at 1, 3, 6, and 12 months statistical analysis: intention to treat

Eligibility criteria:
inclusion criteria : * more than 18 and less than 70 years old * low back pain * daily pain for at least 3 months * pain level during the last 48 hours \> 40 on the numeric pain scale (0-100) * lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections) * modic i discopathy on mri * intra-discal injection at least 6 months before inclusion * written informed consent * social security * medical examination non inclusion criteria : * pregnancy * hypersensitivity to methylprednisolone or contrast * local or general infection * previous disc surgery less than 6 months * steroid treatment * previous infectious spondylodiscitis * ankylosing spondylitis * sciatica with neurologic defects * uncontrolled psychiatric conditions * inability to read or understand french language * anti-vitamin k treatments * severe coagulation diseases * fever \> 38 or sedimentation rate \> 20 * discopathy with modic 1 signal on several different lumbar stages

Keywords: low back pain steroid injection inter-vertebral disc randomized trial lack of efficacy of usual recommended treatments more than 40 on the pain numeric scale (0-100) inflammatory discopathy (modic i) on mri