Kornimate/medical-research-clean huggingface dataset:
physical exercise in hypertension, randomised clinical trial

Conditions: Hypertension

Summary: endurance training has a documented effect on hypertension. however, only low to moderate training intensity has so far been studied. high aerobic intensity should, from physiological considerations, prove more effective in also reducing high blood pressure. the present study is a randomised comparison of high versus moderate intensity versus training in groups, and general advice on 24 hour blood pressure in hypertensives. the training period is 12 weeks, with follow-up after 1 year. maximum oxygen uptake, quality of life, left ventricular function and blood vessel reactivity are also measured.

endurance training has documented effect on blood pressure in hypertension. however, only low to moderate training intensity has so far been studied. higher aerobic intensity based on individual measurements of maximum oxygen uptake is more efficient in increasing oxygen uptake, and might prove more effective in lowering blood pressure. group training, on the other hand is not individualised, but less personnel required and may prove more cost effective. endurance training is shown to improve both systolic and diastolic left ventricular function, as well as endothelial function. both can be measured non-invasively by ultrasound. the study is an open, randomised study with four arms, comparing: * high aerobic intensity interval training * moderate aerobic intensity training * group training * controls receiving standard advice on lifestyle and training training effect is measured by max. oxygen uptake, blood pressure by continuous 24 hour ambulatory measurement, left ventricular function by echo doppler and endothelial function by flow mediated vasodilation by ultrasound. the effect of exercise on blood pressure is dependent on continued training. all patients will be followed up after one year.

Eligibility criteria:
inclusion criteria: * essential hypertension grade 1 - 2 without medical treatment exclusion criteria: * end organ damage * two or more cardiovascular risk factors * diabetes

Keywords: hypertension endurance training endothelial function left ventricular function echocardiography quality of life essential hypertension grade 1 - 2
allogeneic mesenchymal stem cells for radiation-induced hyposalivation and xerostomia/dry mouth

Conditions: Xerostomia Due to Radiotherapy; Hyposalivation; Xerostomia; Oropharynx Cancer; Salivary Gland Diseases; Dry Mouth; Mesenchymal Stem Cells; Mesenchymal Stromal Cells; Stem Cells

Summary: an investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (mscs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma

patients with previous oropharyngeal cancer and radiation-induced hyposalivation and xerostomia (dry mouth syndrome) will receive intraglandular injections of allogeneic adipose-derived mscs into the submandibular and parotid glands. the trial will be good clinical practice (gcp) monitored. from healthy donors, mscs will be produced at a good manufacturing practice (gmp) facility. the patients will be followed for four months for safety, tolerability, and efficacy registration. changes in quality of life, unstimulated, and stimulated whole saliva flow rate, salivary gland function will be assessed. immune response towards receiving allogeneic mscs will be evaluated in plasma and saliva. changes in the composition and quality of the whole saliva will be investigated. saliva from the participants will altså be compared to saliva from ten healthy controls.

Eligibility criteria:
inclusion criteria: 1. age between 18-75 years 2. previous radiotherapy +/- chemotherapy for opscc stage i- ii (uicc-8, 2017) 3. 2 years' follow-up without recurrence 4. clinically reduced salivation and hyposalivation, evaluated by a screening 5. unstimulated salivary flow rate between 0.2ml/min and 0.05ml/min 6. grade 2-3 xerostomia (ctcaev5.0) 7. who performance status (ps) 0-1 8. informed consent exclusion criteria: 1. any cancer in the previous 4 years (not including opscc and basocellular carcinomas) 2. xerogenic medications 3. penicillin or streptomycin allergy 4. any other diseases of the salivary glands, e.g. sjögren's syndrome or sialolithiasis 5. previous parotid or submandibular gland surgery 6. previous treatment with any type of stem cells 7. breastfeeding, pregnancy or planned pregnancy within the next 2 years 8. smoking within the previous 6 months. 9. alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (danish national board health alcohol guidelines3) 10. any other disease/condition judged by the investigator to be grounds for exclusion

Keywords: xerostomia due to radiotherapy
combined use of coronary mdcta, coronary doppler ultrasonography and pet perfusion in diagnosing coronary artery disease

Conditions: Coronary Artery Disease

Summary: multislice ct angiography is a novel but already established and widely used in diagnosing coronary artery disease (cad). it is very reliable in ruling out hemodynamically significant narrowings in coronary arteries (negative predictive value). however, it may overestimate the severity of the stenoses in up to 30% of the coronary artery lesions (positive predictive value 70%). however, when coupled with a functional or flow-sensitive diagnostic test, such as pet perfusion or coronary doppler ultrasonography, one can assume that even the ppv may be as high as 95 %. despite this assumption, there's no scientific evidence to support use of such hybrid multi-modality tests at present. the investigators hypothesis is that improving the diagnostic accuracy of non-invasive diagnosis of coronary artery disease will decrease the proportion of patients that need catheter angiographies. the avoidance of these unnecessary invasive procedures will improve patients´ quality of life and may even redirect health care resources in a more efficient way.

coronary mdcta (multi-detector ct angiography) is a novel but already established and widespread diagnostic method to diagnose coronary artery disease. when performed with a 64-detector (slice) ct, its strength is an excellent negative predictive value, npv (98%). specificity (86%) is good but the positive predictive value (ppv) is only moderate (70%). this is due to the ability of mdcta to detect even minor vessel wall changes before they are functionally significant, and the tendency of ct to overestimate the volume of dense calcifications. however, when coupled with a functional or flow-sensitive diagnostic test, such as pet perfusion or coronary doppler ultrasonography, one can assume that even the ppv may be as high as 95 %. despite this assumption, there's no scientific evidence to support use of such hybrid multi-modality tests at present. our hypothesis is that improving the diagnostic accuracy of non-invasive diagnosis of coronary artery disease will decrease the proportion of patients that need catheter angiographies. the avoidance of these unnecessary invasive procedures will improve patients´ quality of life and may even redirect health care resources in a more efficient way.

Eligibility criteria:
inclusion criteria: * informed consent * age 40 - 80 years * stable chest pain * likelihood of obstructive coronary artery disease more than 25% based on gender, age, symptoms and exercise test exclusion criteria: * irregular rhythm * hypersensitivity to contrast agents * unstable chest pain * decompensated congestive heart failure * abnormal kidney function * 2nd or 3rd degree av block * severe bronchial asthma * pregnancy * age over 80 years * previously diagnosed coronary artery disease

Keywords: coronary artery disease mdct positron emission tomography ultrasound
clinical performance evaluation of aqt90 flex bnp and nt-probnp

Conditions: Heart Failure

Summary: the aqt90 flex b-type natriuretic peptide (bnp) and n-terminal pro b-type natriuretic peptide (nt-probnp) tests are in vitro diagnostic assays intended as an aid in the diagnosis and assessment of the severity of heart failure in point-of-care and laboratory settings. the purpose of the study is to establish the clinical performance of the aqt90 flex bnp and nt-probnp assays for both whole blood and plasma in the intended use population.


Eligibility criteria:
inclusion criteria: * subject is 21 years of age or older * subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study * subject has diagnosis of heart failure exclusion criteria: * subject has acute coronary syndrome (acs) * subject has been diagnosed and/or treated for malignancy within past 6 months * subject has had cardiac surgery within the past 4 weeks * subject claim of pregnancy * subject's prior participation in this study
a trial of preoperative mm-121 with paclitaxel in her2-negative breast cancer

Conditions: ER Positive, Her2 Negative Breast Cancer Patients; Triple Negative Breast Cancer Patients

Summary: to demonstrate whether addition of mm-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in her2 negative locally advanced operable breast cancer patients.

this is a multicenter, open-label, randomized, phase ii study of preoperative mm-121 with paclitaxel in her2-negative breast cancer. patients will be randomized to receive paclitaxel with or without mm-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.

Eligibility criteria:
inclusion criteria: * histological confirmation of er positive, her2 negative invasive breast cancer (group 1) or invasive triple-negative breast cancer (group 2) * free of metastatic disease * ≥ 18 years old * female * had no prior treatment for any cancer * eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide exclusion criteria: * have a history of severe allergic reactions to paclitaxel or other drugs formulated in cremaphor® el * are pregnant or breastfeeding

Keywords: breast cancer neoadjuvant her2 negative her2 non-overexpressing estrogen receptor positive triple negative mm-121 paclitaxel
alipogene tiparvovec for the treatment of lpld patients

Conditions: LPL Deficiency

Summary: the aim of the study is to provide further confirmatory evidence of clinical benefit in lpld patients treated with alipogene tiparvovec by assessing both the "clinical response" (as defined by a range of parameters), and "the metabolic response" (postprandial cm metabolism) in lpld patients with and without an immunosuppressant regimen.

this is a prospective, interventional, randomised, open-label, parallel group study evaluating the clinical response as well as the dynamics of postprandial chylomicron metabolism in patients treated with alipogene tiparvovec with and without immunosuppressants. the study will be conducted in 12 lpld patients who will be randomised into the immuno+ (cyclosporin and mycophenolate mofetil) or the immuno- group.

Eligibility criteria:
main inclusion criteria are: * patients with a history of severe or multiple pancreatitis attacks despite dietary fat restriction. * genetically confirmed diagnosis of lpld * post-heparin plasma lpl protein mass \> 5% of normal * lpl activity ≤20% of normal (in post- heparin plasma) * fasting plasma tg concentration \>10 mmol/l. main exclusion criteria are: * females with a positive pregnancy test or who are breastfeeding, or on contraceptive use. * patients with a positive hiv, hepatitis b, hepatitis c or being positive for tuberculosis. * patients under treatment with antiplatelet or other anti-coagulants. * patient allergic to or having a condition that prohibits the use of immunosuppressants.
study to evaluate the effect of age (geriatric) and kidney function on the safety, efficacy and pharmacokinetics of octreoscan in patients who have new or recurrent tumors

Conditions: Solid Tumors

Summary: the objective of this study was to evaluate the effect of age (geriatric) and renal function on the safety, efficacy and pharmacokinetics of octreoscan at the recommended clinical dose in this patient population.


Eligibility criteria:
inclusion criteria: 1. males or females 18 years of age and older. 2. if female and of childbearing potential, patients must have a negative pregnancy test within 24 hours of study drug administration. in addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study. 3. if deemed necessary by the principal investigator, patients entering the pharmacokinetic population must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration. 4. patients (when able) or legally authorized representatives must have the ability to understand the requirements of the study and provide written consent to participate and agree to abide by the study requirements. 5. patients must have tumor localization by conventional imaging methods prior to enrollment (i.e., ct, mri, us, angiogram). 6. patients referred for scintigraphy of solid tumors with a high suspicion of containing somatostatin receptor positive tissue. 7. patients with first-time tumors must be scheduled for a tissue biopsy. a tissue sample will be sent to the core laboratory for conventional histology and immunohistochemistry analysis. 8. patients with recurrent tumors or progressive tumors must have previous biopsy results documented, with previous biopsy tissue obtainable for immunohistochemistry analysis. exclusion criteria: 1. patients receiving sandostatin lar \< 21 days prior to dosing or sandostatin immediate release (im) \< 24 hours prior to dosing. 2. patients who have received any investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period (patients on a research protocol using an approved drug are accepted). 3. patients who are pregnant, breastfeeding or lactating. 4. patients with a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. 5. patients scheduled to undergo any scintigraphy within 7 days prior to study participation or pet scanning within 24 hours prior to study participation.

Keywords: tumor somatostatin receptor
total knee replacement study using standard cutting guide vs otismed mri generated cutting guide

Conditions: Osteoarthritis of the Knee

Summary: patients are referred to the va orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. those who qualify for the knee replacement are informed about the study. those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a mri generated cutting guide called otismed. all patients have an mri so both groups will be unaware of which surgical technique is used. all patients receive the usual pre-op care and same type of replacement knee. follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. patients will be informed of which surgical technique they were randomized to at the conclusion of the study.

objective(s): primary: compare the surgical and clinical outcomes between patients receiving total knee replacement after random assignment to one of two groups: 1. surgical procedure with the standard knee cutting guide and 2. surgical procedure with the otismed mri generated cutting guide secondary: evaluate the cost benefit ratio related to the two different cutting guide uses. research plan: all patients that are referred to orthopedics, are eligible for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate. patients will be randomly assigned to either the standard or the otismed group. all patients will have a mri of the knee. patients and the research staff conducting measurements will be blinded to the type of cutting guide used for the surgery. methods: the study will be a randomized trial with the patient and data collector blinded to type of cutting guide used for the surgical procedure. the study will be conducted at one site and enrollment goal is 100 patients. data collection will be done preoperatively and at 4 wks, 3 months, 6 months, one year and two year. established instruments, the (western ontario and mcmaster universities osteoarthritis index) womac and oxford knee score, will be used. measurements will be done to evaluate rom (range of motion) and assess post-op recovery. surgical data and hospitalization data will be used for analysis of costs. statistical analysis will be used for comparison of the two groups.

Eligibility criteria:
inclusion criteria: * all veterans that are referred to orthopedics surgical clinic for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate. exclusion criteria: * patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an mri will be excluded.

Keywords: alignment
glucagon-like peptide-2 mediated secretion of stored enteral lipids

Conditions: Hyperlipidemias

Summary: some of the fat (triglyceride) from the food humans eat gets stored in the bowel. this triglyceride can then be released into the blood when another meal is consumed or in response to hormones. how the gut hormone glucagon-like peptide-2 (glp-2) releases the triglyceride from the gut is not known. the research team in this study is interested in finding out how teduglutide (a degradation resistant form of glp-2) releases stored triglyceride from the gut by studying samples from patients undergoing endoscopy and small bowel biopsy.

the release of stored enteral lipids will be investigated in 30 patients undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications. patients undergoing the procedure will be recruited. participants will have a high fat liquid meal as breakfast. 5 hours later, participants will be randomly assigned to receive either a subcutaneous injection of placebo (n=15) or a subcutaneous injection of the health canada approved glucagon-like peptide-2 (glp-2) analogue (teduglutide, revestive®, shire canada)(n=15 different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3 sample sites,snap frozen in dry ice and stored at -80°c for further analysis.

Eligibility criteria:
inclusion criteria: * men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by dr. bookman of the kensington screening clinic, toronto, on, canada exclusion criteria: * patients with active inflammatory bowel disease * patients with pre-existing celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption * patients with active bowel malignancy * patients with diabetes mellitus or known/ suspected motility disorders of the gut * patients with decompensated liver disease * patients on ezetimibe or bile acid sequestrants * patients who are pregnant or breastfeeding. * patients with renal disease * patients on benzodiazepine * unstable cardiac or respiratory disease * any changes to medication in the preceding month

Keywords: intestinal lipoprotein duodenal biopsy gut peptide chylomicrons
study of cm313(sc) injection in systemic lupus erythematosus(sle)

Conditions: Systemic Lupus Erythematosus

Summary: to evaluate the efficacy and safety of cm313(sc) injection in systemic lupus erythematosus(sle)


Eligibility criteria:
inclusion criteria: 1. males or females aged 18 to 65 years. 2. voluntarily signed the informed consent form (icf). 3. patients were diagnosed with systemic lupus erythematosus(sle) according to the diagnostic classification criteria of the european league against rheumatism (eular)/american college of rheumatology (acr) in 2019. 4. systemic lupus erythematosus disease activity index - 2000(sledai-2k) score ≥6 during screening, and sledai-2k clinical score (except for low complement and/or positive anti-dsdna antibodies) ≥4 during screening and at baseline. 5. positive antinuclear antibody and/or anti-dsdna antibody results defined in accordance with the laboratory reference value range of the central laboratory during the screening. 6. ≥1british isles lupus assessment group-2004 (bilag-2004) organ system rated as a or ≥ 2 organ system rated as b, and physician's global assessment(pga) score ≥1.0 during screening. 7. maintain a stable standard treatment regimen for at least 30 days prior to initial dosing of the investigational product. exclusion criteria: 1. kidney disease: severe lupus nephritis within within 8 weeks prior to randomization. 2. patients with systemic lupus erythematosus(sle) or non-sle related central nervous system disease within 8 weeks prior to randomization. 3. there were non-sle inflammatory skin or joint diseases that the investigators thought might be evaluated during the screening period. 4. history of clinically significant diseases.
the effect of person-centered care applied to patients with dementia on nutritional status

Conditions: Dementia

Summary: the aim of this study is to examine the effect of person-centered care on nutritional status of patients with dementia. in this study, we think that since the practices that reduce the eating difficulties of patients with dementia and prevent possible problems will be applied in a person-centered manner, a different perspective will be developed in this field and will affect the care of the patients more positively.

in line with the observations made and the patient\&#39;s wishes, montessori application, landscaping, special equipment such as high-contrast colored crockery, flatware, and spill-free containers, positive communication, effectiveness person-centered care interventions such as activities will be implemented and their effects on nutritional status will be evaluated (pre-test - post-test). test randomized control group experimental design). no intervention will be made to the control group, they will only be observed.

Eligibility criteria:
inclusion criteria: * being over 65 years old, * being diagnosed with dementia * being able to step on the scale (no lower extremity loss) exclusion criteria: * acute disease state (pneumonia), * patients with peg, * patients with severe visual and hearing impairment, * mild dementia patients, * parkinson\&#39;s patients, * patients with head trauma

Keywords: dementia person-centered edfed feeding difficulty