Kornimate/medical-research-clean huggingface dataset:
framed infrainguinal venous bypass versus conventional autologous bypass trial

Conditions: Peripheral Arterial Occlusive Disease; Femoropopliteal Artery Occlusion; Femoropopliteal Stenosis; Critical Limb-Threatening Ischemia; Claudication, Intermittent

Summary: the purpose of this clinical trial is to analyze patency after autologous infrainguinal bypass surgery in patients receiving a venous conduit versus a covered venous conduit.

patients presenting to vascular surgical units are usually multimorbid with increased cardiopulmonary risk. autologous venous bypass is indicated in certain situations despite the longer duration of surgery. optimizing patency has been an important goal since many years. reconstruction problems are often based on intimal hyperplasia, which can be reduced via covering of the harvested vein as seen in previous studies. this clinical trial will be conducted at our division of vascular surgery and endovascular surgery at the university hospital of salzburg. patients will be randomized into one of the two treatment options, which are a plain venous conduit or a by mesh covered venous conduit. during this clinical trial, the first follow-up will take place after 6 weeks; this corresponds to the usual follow-up interval. due to the trial, further follow-ups will take place for each of the patients after 3 months, 6 months, 12 months, 2 years.

Eligibility criteria:
inclusion criteria * age at least 18 years * informed consent form with signature * rutherford category 3 (\<200m) or chronic critical ischemia (rutherford category 4-6) * assured inflow and recipient artery. exclusion criteria * pregnant or breastfeeding women * active infection or sepsis * acute ischemia * endovascular procedure in the region to be treated. * vein with outer diameter \ 8 mm under pressure. * spliced veins. * known allergy to the cobalt-chromium alloy (astm 1058) or its components (cobalt-chromium-iron-nickel-molybdenum). * vasculitis * coagulopathy * radiation therapy near the anastomosis

Keywords: extraluminal bypass stenting autologous vein graft bypass extremity graft
calcitriol monotherapy for x-linked hypophosphatemia

Conditions: X-linked Hypophosphatemia; Hypophosphatemic Rickets; Hypophosphatemic Rickets, X-Linked Dominant

Summary: children and adults with xlh recruited will be treated with calcitriol alone (without phosphate supplementation) for one year, during which the calcitriol dose will be escalated during the first 3 months of therapy. the investigators hypothesize that treatment of adults and children with xlh alone will improve serum phosphate levels and skeletal mineralization without causing an increase in kidney calcifications. the study will also examine if calcitriol therapy will improve growth in children.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of xlh with family history excluding male-to-male transmission, or positive genotype for phex mutation * serum pth levels less than 1.5x the upper limit of normal * serum calcium levels less than 10.0 mg/dl * egfr \>= 60 ml/min/1.73m2 * 25(oh) vitamin d level \>= 20 ng/dl exclusion criteria: * known allergy to calcitriol * pregnancy or breast feeding * use of skeletally active agents such as bisphosphonates, teriparatide, serms, hormone replacement therapy and progesterone-only contraceptive agents (combination oral contraceptive use in premenopausal women is not an exclusion criterion). * unwilling or unable to stop therapy with calcitriol and phosphate therapy for two weeks prior to study * therapy with cinacalcet within the past two weeks * current use of growth hormone therapy * use of diuretics or medications that alter renal handling of mineral ions. * use of glucocorticoids for more than 14 days in the past 12 months with the exception of inhaled agents. * history of malignancy except basal and squamous cell carcinoma of the skin. * significant history of psychiatric disease per dsm-5. * substance use disorder per dsm-5. * significant cardiopulmonary disease (unstable cad or stage d acc/aha heart failure). * absence of laboratory values for serum calcium, phosphate and creatinine in the 24 months prior to enrollment.

Keywords: xlh calcitriol x-linked hypophosphatemia rickets 1,25 dihydroxyvitamin d bone disorder rare bone disease vitamin d hypophosphatemic rickets
preoperative optimization of diabetic patients

Conditions: Diabetes; Surgery Related Complications Rate

Summary: diabetic patients, as part of preoperative evaluation, should have glycated hemoglobin (hba1c) measured. hba1c provides information on longterm glucose control. there is a suggestion in the literature that elevated a1c levels predict a higher rate of postoperative adverse events, including infections, myocardial infarction, and mortality. it is unclear whether chronic glycemia, as reflected in raised hba1c level, is the risk factor for adverse perioperative events or whether it is a surrogate measure for poor perioperative glucose management. conversely, in a retrospective analysis of 431,480 surgeries perioperative glucose was predictive of increased 30-day mortality, but that hba1c was a less useful predictor of this measure. in our experience of at the university of alberta preadmission clinic there is significant variability with respect to whether diabetic patients have a valid hba1c measurement i.e. within 3 months of surgery. if a valid measurement is present, there is also considerable variability with respect to diabetes control.

purpose: the purpose of this study to retrospectively determine the incidence of diabetes in the surgical population and what proportion of diabetic patients have a valid hba1c. hypothesis: a valid (measured within 3 months of surgery) hba1c measurement is frequently missing prior to surgery and when present has a high chance of being higher than normal. objectives: perform a retrospective analysis of all surgeries in alberta from november 2019 to the present time looking for the following: primary outcomes: 1. determine the incidence of diabetes in the surgical population and describe the demographics and clinical charcteristics of patients 2. determine the incidence of valid hba1c in diabetic patients presenting for surgery 3. determine long-term diabetes control through assessment of hba1c values in diabetic patients presenting for surgery secondary outcomes: 1. determine association between hba1c and post-operative length of stay 2. determine association between hba1c and in hospital mortality design: this study will be a population-based, retrospective observational cohort study. setting: alberta hospitals participants: adults with diabetes having surgery in alberta since november 2019 descriptive statistics will be tabulated according to hba1c status and univariate comparisons of means, medians and proportions will be performed to evaluate the association of independent variables with primary and secondary outcomes. normally distributed continuous data will be reported as means with standard deviations (sd). non-normally distributed continuous data will be reported as medians with interquartile ranges (iqr). categorical variables will be compared using chi-square test for independence

Eligibility criteria:
inclusion criteria: * age 18 or greater * having any surgical procedure at any hospital in alberta exclusion criteria:
transcranial direct current stimulation for motor function and fatigue in pd

Conditions: Parkinsons Disease (PD)

Summary: the investigators hypothesize that multi-session anodal tdcs (atdcs) of the left dorsolateral prefrontal cortex (ldlpfc) will induce long-lasting effects in improving motor function and reducing motor fatigue and fatigability in pd patients.

parkinson's disease (pd) is the fastest growing and second most common neurodegenerative disease (after alzheimer's disease) and affects approximately one million people in the united states. impaired motor function is one of the cardinal features of pd. one of the diagnostic criteria for pd is bradykinesia (slowness of movement). in addition to bradykinesia, pd patients also suffer from increased motor fatigue and motor fatigability. in the body of fatigue research, the term "motor fatigue' usually refers to the general sensation of tiredness or of difficulty in initiating physical activity experienced over several days to weeks. this is often assessed by questionnaires completed by the subject. the term 'motor fatigability' refers to difficulty in maintaining physical activity at a desired level (lou, 2009). this is often assessed quantitively in a laboratory setting. motor impairments, motor fatigue, and motor fatigability affect quality of life in patients with parkinson's disease. transcranial direct current stimulation (tdcs) is a noninvasive and safe brain stimulation technique that has been shown to be effective in improving motor function in subjects with parkinson's disease. during tdcs, low-voltage, low amplitude current is passed through a pair of surface electrodes placed over the areas of brain of interest. the specific aim of this study is to examine if atdcs to ldlpfc at 2 milliamps (ma) for 20 minutes daily for 5 days will improve motor function and reduce motor fatigue and fatigability in pd patients. the study will examine if the effects may last for two weeks.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pd with at least two of the four diagnostic criteria for pd (tremor, rigidity, bradykinesia, and postural instability) * must be able to consent exclusion criteria: * patients with dementia (moca \< 21) * pd treatment using deep brain stimulation (dbs) * diagnosis of psychosis * diagnosis of multiple sclerosis * diagnosis of stroke * diagnosis of chronic obstructive pulmonary disease (copd) * diagnosis of congestive heart failure (chf)

Keywords: parkinsons disease tdcs motor function motor fatigue
aerobic and strength training exercise in improving fitness and arm health during and after radiation therapy in patients with stage ii-iii breast cancer

Conditions: Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this randomized pilot phase i/ii trial studies how well aerobic and strength training exercise works in improving fitness and arm health during and after radiation therapy consisting of regional nodal radiation in patients with stage ii-iii breast cancer. aerobic and strength training exercise training during and after radiation therapy may reduce treatment related toxicities and improve adherence to exercise long term in patients with breast cancer.

primary objectives: i. to determine the feasibility of conducting an exercise program during and after radiation therapy and to determine what percent of patients will complete the exercise program. (pilot) ii. to determine the percent increase in fitness as measured by the 6 minute walk test in women receiving radiation therapy for breast cancer randomized to an exercise program at 1 year. (phase ii) secondary objectives: i. percent adherence to exercise at 1 year as measured by the international physical activity questionnaire and exercise logs. ii. subjective arm health at 1 year as measured by functional assessment of cancer therapy questionnaire for breast cancer version 4 (fact-b+4). iii. arm lymphedema at 1 year as measured by arm circumference. iv. arm range of motion at 1 year as measured by goniometry. v. quality of life at 1 year as measured by fact-b+4. vi. percent increase in arm strength as measured by one repetition maximum at 1 year. vii. change in weight and body mass index (bmi) 1 year after completion of radiation. outline: patients are randomized to 1 of 2 arms. arm i: patients receive usual care for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. arm ii: patients undergo a supervised aerobic and strength training exercise session over 40-60 minutes 3 times weekly for 6 weeks during radiation therapy and for 12 weeks after completion of radiation therapy. after completion of study, patients are followed up at 1 year.

Eligibility criteria:
inclusion criteria: * stage ii-iii breast cancer * prior surgery including lumpectomy or mastectomy and sentinel node biopsy or axillary lymph node dissection * prior chemotherapy in the neoadjuvant or adjuvant setting * radiation plan consisting of regional nodal radiation * must be suitable for an exercise program exclusion criteria: * serious underlying medical comorbidity such as uncontrolled hypertension, cardiovascular disease, pulmonary disease, psychiatric illness, or any other condition for which the patient is not approved for exercise by their physician * physical handicap that would prevent participation in program * patients with metastatic breast cancer
rhtsh, thyroid size, and radioiodine therapy in benign goiter

Conditions: Benign Nontoxic and Toxic Goiter; Graves' Disease

Summary: the trials in this protocol deals with the effect of pretreatment with rhtsh on radioiodine treatment of thyroid size and function, in patients with nontoxic and toxic nodular goiter. it is an introduction of a novel principle, based on prospective, randomized double blind investigations. attached to this, we investigate the acute effects of rhtsh on thyroid size (measured by ultrasonography), both in healthy individuals and in patients with nontoxic nodular goiter. thus, the investigations are divided into 4 categories listed below: 1. prospective randomized double blind study of pretreatment with 0.3 mg recombinant human tsh for the effect of radioiodine in nontoxic multinodular goiter. 2. prospective randomized double blind study of the pretreatment with 0.3 mg recombinant human tsh for the effect of radioiodine on thyroid size and function in patients with a very large (\>100 ml) nontoxic or toxic goiter. 3. does administration of 0.9 mg recombinant human tsh affect thyroid function and volume in healthy individuals? a randomized double-blind cross-over trial. 4. does administration of 0.3 mg recombinant human tsh affect thyroid function and volume in healthy individuals and in patients with multinodular non-toxic goiter? a randomized double-blind cross-over trial. as a final note we investigate, in a pilot-study; 5. the influence of rhtsh on thyroid radioiodine uptake in patients with hyperthyroidism treated with continuous block-replacement therapy.


Eligibility criteria:
inclusion criteria: * healthy volunteers with an intact thyroid gland * patients with nontoxic/subtoxic nodular goiter confirmed by ultrasonography * patients with toxic nodular goiter * patients with graves' disease exclusion criteria: * treatment with drugs that alter thyroid function or size (the last 3 months prior to inclusion) * prior 131i treatment * alcohol, medicine or drug abuse * pregnancy or lactation * no safe contraception * participation in another clinical trial * allergic reaction towards rhtsh * fine needle biopsy without valid diagnostic criteria for benign disease * suspicion of malignancy, increased ionized serum calcium and/or serum calcitonin * incontinence * physically or psychic condition that hinders corporation * ischemic attack up till 3 months before inclusion

Keywords: benign nontoxic and toxic goiter rhtsh 131i goiter reduction 131i kinetic thyroid size patient satisfaction adverse effects brt graves' disease
glycemic response to two enteral formulas in persons with type 2 diabetes mellitus

Conditions: Diabetes

Summary: this will be a randomized, cross-over design. subjects will be randomized to one of two interventions on two separate study days, 1 week apart.


Eligibility criteria:
inclusion criteria: * age 20-75 yrs * type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (amaryl), glipizide, glucotrol/glucotrolxl) and glyburide (diabeta, micronase, (glynase prestabs); meglitinides such as reaglinide (prandin) and nateglinide (starlix); and alphaglucosidase inhibitors such as acarbose (precose) and miglitol (glyset) * hemoglobin a1c less than 9.0% * fasting blood glucose less than 180 mg exclusion criteria: * abnormal thyroid function * creatinine \>2.0 mg/dl * potassium \<3.5 meq/l * gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting * history of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities * patients currently on any anti-coagulant medication * currently unstable diabetes or under treatment for cancer, heart disease, renal disease * unable to give informed consent or follow instructions * current insulin therapy or insulin therapy within the past month * patient who are pregnant * allergies to milk, fish oil or any component of the test product * patient who in the investigators assessment cannot be expected to comply with treatment * currently participating or having participated in another clinical trial.
early biomarkers in circulating α 4β7 + t cells to predict response to vedolizumab in inflamatory bowel disease patients.

Conditions: Inflammatory Bowel Disease

Summary: background: infiltration of gi by t lymphocytes is a pathogenic mechanism both in ulcerative colitis (uc) and in crohn's disease (cd). vedolizumab (vdz) is a humanized monoclonal antibody binding with high affinity to α4β7 integrin blocking α4β7+-madcam-1 interaction, hence blocking a key step in gi lymphocytes t infiltration. vdz has demonstrated a therapeutic effect in uc and cd. investigators still lack of adequate biomarkers to predict clinical response to biological treatments, specially avoiding invasive procedures. objective: study whether circulating cd4+ and cd8+ α4β7+ memory t lymphocytes and some of their surface markers might be molecular markers of response to vdz treatment in patients with uc and cd. methods: prospective (pilot) study including 24 adult ibd patients (12 uc patients and 12 cd patients (patients with fistulizing perianal disease will be excluded) with active disease and prior failure to anti-tnfα treatments starting treatment with vdz. they will received vdz in standard induction (300mg intravenously, 0-2-6 weeks) and maintenance schemes (300mg intravenously, every 8 weeks). epidemiological and clinical data from every patient will be recorded prospectively. disease activity at weeks 0, 2, 6 and 14 weeks will be evaluated through validated clinical scores, biological parameters and fecal biomarkers. at week 14 response to the treatment will be evaluated by ileocolonoscopy or enteromri. peripheral blood will be obtained from every patient at baseline, before the third infusion of vdz (6th week) and before the first maintenance dose (14th week). blood lymphocytes will be isolated and multicolor flow cytometry will be performed on stored circulating memory t cells. percentage and absolute values of circulating cd4+ and cd8+ α4β7+ memory t lymphocytes as well as several surface markers related to their activation state (hla-dr, cd25), th17 phenotype (il23r, ccr6, intracellular il17a) and th1 phenotype (infγ)will be assessed on α4β7+ memory t cells.


Eligibility criteria:
inclusion criteria: * ulcerative colitis or crohn's disease diagnosis established by lennard-jones criteria * clinically active disease confirmed by endoscopic or radiologic criteria magnetic resonance image (mri) * \>18 years of age * intolerant, refractory or secondary loss of response to anti-anti-tumour necrosis factor (tnf) alfa treatment. exclusion criteria: * crohn's disease with perianal disease * active tuberculosis * current infections (including clostridium difficile and cytomegalovirus) * history of cancer, including hematologic malignancy and solid tumours within 5 years before * history of demyelinating disease * pregnancy or breastfeeding
misoprostol with intrauterine device insertion

Conditions: Contraception

Summary: the purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.

the investigators intend to conduct a randomized double blind study at oregon health and science university and planned parenthood of the columbia willamette. subjects will be approached only after deciding to get an intrauterine. when the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. the subjects will be asked to rate their level of pain at specific points during the insertion. providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.

Eligibility criteria:
inclusion criteria: * nulliparous women (defined as those without a history of pregnancy, despite the outcome, beyond 20 weeks gestation) * ages 18-45 * seeking long-term reversible contraception with an intrauterine device (either mirena or paraguard) through the ohsu center for women's health and planned parenthood of the columbia willamette exclusion criteria: * pregnancy occurring less than 6 weeks from time of presentation * history of prior intrauterine device placement * history of mullerian tract anomalies * history of uterine surgery * allergy or intolerance to misoprostol or other prostaglandin * pelvic inflammatory disease (current or within the past 3 months) * sexually transmitted diseases (current) * puerperal or postabortion sepsis (current or within the past 3 months) * purulent cervicitis (current) * undiagnosed abnormal vaginal bleeding * malignancy of the genital tract * known uterine anomalies or fibroids distorting the cavity in a way incompatible with intrauterine device insertion * allergy to any component of the intrauterine device or wilson's disease (for copper- containing intrauterine device)

Keywords: intrauterine device cervical dilation nulliparous women pain management