Kornimate/medical-research-clean huggingface dataset:
evaluation of sars-cov-2 (covid-19) antibody-containing plasma therapy

Conditions: COVID; Infectious Disease

Summary: in this study, investigators will determine whether the early addition of ht-ccp to standard treatment improves the clinical outcome (as assessed by the modified who ordinal scale) of patients with covid-19 who are hospitalized but not yet in moderate or severe ards.

investigators are doing this research to learn more about high-titer covid-19 convalescent plasma (ht-ccp) transfusion as a possible treatment for people who have covid-19, the coronavirus infection. "ht-ccp" is plasma that contains a high amount of antibodies that were made to fight off covid-19 because it is donated by another person who has also been infected with coronavirus but has recovered, so their immune system has had enough time to make these antibodies. this study is being done to determine whether ht-ccp will help people with covid-19 recover from their infection more quickly and lower their risk of having to go on a ventilator or reduce the time they need to stay on a ventilator. it is not yet known whether ht-ccp helps people with covid-19, which is why the study needs to be randomized, meaning some subjects will be randomly selected to receive ht-ccp while others will be randomly selected to receive ffp.

Eligibility criteria:
inclusion criteria: 1. age \>1 year. 2. active covid-19 infection confirmed by positive sars-cov-2 pcr. 3. meets institutional criteria for admission to hospital for covid-19. 4. admitted to icu or non-icu floor within 5 days of enrollment. 5. pao2/fio2 \>200 mmhg if intubated. 6. patient or lar able to provide informed consent. exclusion criteria: 1. previous treatment with convalescent plasma for covid-19. 2. current use of investigational antiviral therapy targeting sars-cov-2. 3. history of anaphylactic transfusion reaction. 4. clinical diagnosis of acute decompensated heart failure. 5. objection to blood transfusion.
subtherapeutic inr levels in patients with avk: incidence, associated factors, prognosis and control strategies

Conditions: Atrial Fibrillation

Summary: this prospective observational study is to assess the predictive factors of poor control of international normalized ratio (inr) to determine the treatment strategies received by patients with a poor control of inr in real-life clinical practice and to explore the effectiveness and safety of these strategies in patients with non-valvular atrial fibrillation who start vitamin k antagonist (vka) treatment


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years. * patients with a diagnosis of nonvalvular atrial fibrillation according to the criteria of the spanish agency of medicines and medical devices (aemps) (2013) who are treated in cardiology practices. * patients about to start treatment with a vitamin k antagonist or who are in the first two months of treatment. * patients for whom access to at least 80% of inr tests performed during treatment with vitamin k antagonists is expected to be available. * patients with the mental and physical capacity to complete the study questionnaires and give their informed consent to participate in the study. exclusion criteria: * patients with mitral stenosis or another significant valve disease for which specific treatment is scheduled or has already been performed (prosthesis or valvuloplasty). * patients hospitalised at the time of inclusion in the study. * patients with a life expectancy of less than 13 months. * patients who are participating in a clinical trial. * patients receiving double antiplatelet therapy.
proalifun_6.7_health effects of a low-salt bread on hypertensive subjects (proalifun67)

Conditions: Hypertension

Summary: the purpose of this clinical study is to evaluate the health properties of a dietary intervention carried on with an innovative low-salt bread. the hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may improve the compliance to the own regime and that the vascular function, the inflammatory and oxidative state, the composition of the intestinal microbiota and that neurocognitive and neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with low-salt bread.

this clinical trial is a multi-center, randomized, controlled, open label, pilot study, lasting 6 months. a target number of seventy individuals with hypertension meeting inclusion and exclusion criteria, assessed at enrollment, and which have signed the informed consent, will be recruited.

Eligibility criteria:
inclusion criteria: * arterial hypertension stage i-ii * stable control of blood pressure * egfr \> 60 * informed consent signed exclusion criteria: * uncontrolled hypertension * therapy with diuretics * need for therapy with more than three antihypertensive drugs * proteinuria greater than 1 g/day * celiac disease * systemic inflammatory diseases * suspicion or clinical diagnosis of malignancy * chronic liver disease * treatment with corticosteroids or immunosuppressive drugs * previous acute cardiovascular diseases (myocardial infarction, stroke) * psychiatric conditions reducing the compliance to treatment protocols

Keywords: salt intake functional food low-salt bread blood pressure
evaluation of an integrated imaging system for in vivo detection of fluorescently labeled lesions

Conditions: Invasive Breast Cancer

Summary: this is a pilot study to test and characterize the ability of the smart goggles system to detect fluorescently labeled sentinel lymph nodes (slns). specifically, this study will test the sensitivity and specificity of the smart goggles to detect indocyanine green (icg) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of icg (cardio-greentm), under standard-of-care application conditions.

primary objective -positive fluorescence signal in slns imaged by the smart goggles system. secondary objectives * confirmation of icg within lesions per histologic tissue exam by sln biopsy. * comparison of lesions detected by the smart goggles vs. lesions detected using spy/quest/pde vs. gold standard of gamma probe and blue dyes. exploratory objectives -collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer study design this is an unpowered pilot study to determine the sensitivity of the new smart goggles device, for detection of icg fluorescence in slns of breast cancers in a clinical setting. the investigators have chosen to examine icg as the contrast agent and breast cancer as the clinical target, because this agent is fda-approved and is regularly used for lymphatic mapping (skin cancers). the study team will be applying icg for the same length of time as the standard-of-care procedures including radiotracers and blue dyes. the study involves a single visit, lasting \~3-4 hours total. multiple sln biopsies will be performed if multiple slns are identified.

Eligibility criteria:
inclusion criteria: * subjects with at least 1 lesion of tumor of the breast * subjects must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * subjects who have been treated with radiation therapy on the chest. * has had previous sentinel lymph node biopsy * has a known hypersensitivity to icg, methylene blue and 99mtc-colloid.

Keywords: smart goggles sentinel lymph nodes indocyanine green cardio-green spy elite quest pde
accuracy of bladder scanners in post-operative voiding trials

Conditions: Pelvic Floor Disorders

Summary: the investigators are trying to determine if using a bladder scanner (type of ultrasound) to check how much urine is left in the bladder is the same as checking that volume with a catheter (tube that goes into your bladder to drain urine). after urogynecologic surgery, the investigators perform a voiding trial. water is put into the participant's bladder through the catheter (tube draining your bladder). the catheter is then removed and the participant is asked to empty their bladder. after that, the investigators will use the bladder scanner (ultrasound) to see how much urine is left in the participant's bladder. after the ultrasound, the investigators will pass a very small catheter (tube) into the bladder to take out the remaining urine. the investigators will then compare the amount obtained from the catheter to the ultrasound amount. this will also help the investigators to figure out if they need to check how much urine is left in a patient's bladder after the voiding trial.

the primary aim of this study is to determine if bladder scanners are accurate in determining a post-void residual volume (pvr) after urogynecologic surgery. the secondary aim of this study is to determine if a post-void residual volume (pvr) measurement is needed after a back-fill voiding trial on urogynecologic post-op patients.

Eligibility criteria:
inclusion criteria: * undergoing urogynecologic surgery * able to consent * greater than 18 years old * non pregnant exclusion criteria: * need for prolonged catheterization * unable to consent * prisoner
pharmacologic effect for female overactive bladder syndrome: mirabegron versus solifenacin

Conditions: Overactive Bladder Syndrome

Summary: to assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and bladder blood flow.

to assess the impact of mirabegron versus solifenacin on psychological distress, sexual function, bladder wall thickness and blood flow.

Eligibility criteria:
inclusion criteria: * overactive bladder syndrome exclusion criteria: * allergy to mirabegron or solifenacin. * patients with severe hypertension who are difficult to control, known urethral diverticulum, known bladder malignant tumors, urinary retention patients, gastric retention patients, uncontrolled angular glaucoma patients, dialysis patients, severe renal dysfunction , moderate liver dysfunction, use strong inhibitors of cyp3a4 such as ketoconazole.
study on the management model of "home treatment" for tuberculosis patients

Conditions: Tuberculosis, Pulmonary

Summary: this project aims to standardize the management of "home treatment" for tuberculosis patients, improve the compliance of patients with treatment, reduce the risk of transmission, and study the establishment of "home treatment" management model for tuberculosis patients.

the project intends to optimize the standardized management framework and process of "home treatment" for tuberculosis patients by introducing mobile internet technology as a means of patient management and formulating "home treatment" infection control norms, and ultimately form a management model suitable for "home treatment" for tuberculosis patients.through prospective study to evaluate the effect of this model on the treatment compliance of "home treatment" patients and the impact on tuberculosis infection and incidence of close contacts, so as to further improve the "home treatment" management model. the research results of this project will provide policy basis for beijing to formulate "home treatment" management of tuberculosis progress.

Eligibility criteria:
inclusion criteria: pathogenic comfirmed positive tb patients new pathogenic positive pulmonary tuberculosis patients treated by home treatment tb assistant app user exclusion criteria: unconscious unable to answer questions -

Keywords: tuberculosis home treatment management infection control
efficacy and safety of octreotide capsules (mycapssa) in acromegaly

Conditions: Acromegaly

Summary: octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. in a recent phase 3 trial, oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

this is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. at the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules. this study received agreement from the fda, under a special protocol assessment.

Eligibility criteria:
inclusion criteria: * documented evidence of active acromegaly * treatment with somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy * biochemically controlled exclusion criteria: * patients taking injections of long-acting somatostatin receptor ligands (srls) not as indicated in the label * pituitary surgery within six months * conventional or stereotactic pituitary radiotherapy any time in the past * patients who previously participated in ch-acm-01 or ooc-acm-302 * any clinically significant uncontrolled concomitant disease * symptomatic cholelithiasis * pegvisomant, within 24 weeks * dopamine agonists, within 12 weeks * pasireotide, within 24 weeks

Keywords: octreotide capsules, acromegaly, optimal, mycapssa
effect of dapagliflozin on glycemic variability

Conditions: Type 2 Diabetes Mellitus

Summary: dapagliflozin improves glycemic variability in subjects with type 2 diabetes mellitus when added to insulin therapy. the primary objective of this study is to assess the effect of dapagliflozin on glucose variability compared to placebo after 12 weeks of treatment in type 2 diabetic patients with inadequate glycemic control on insulin.

this study is a multicenter, randomized, double-blind, placebo-controlled phase 4 study to evaluate whether treatment with dapagliflozin add-on to insulin reduces glucose variability in type 2 diabetes mellitus. the study will recruit type 2 diabetes mellitus patients with inadequate glucose control on insulin treatment with or without metformin or sulphonylurea. it is estimated that 90 type 2 diabetic patients will be enrolled. after randomization, a total 12 week treatment of dapagliflozin or matching placebo will be administered. before and after treatment, tests for efficacy and safety outcomes will be performed.

Eligibility criteria:
inclusion criteria: 1. female and male aged 20\~70 years 2. type 2 diabetes patients 3. treatment on basal insulin therapy ≥0.2u/kg/day(±metformin and/or ±sulfonylurea) for at least 12 weeks 4. inadequate glycemic control ; hba1c 7.0%\~10.0% at screening 5. female of childbearing potential agrees to routinely use of adequate contraception from signing of the informed consent throughout the duration of the study 6. understands the study procedure, alternatives, and risks and voluntarily agrees to participated by giving written informed consent exclusion criteria: 1. type 1 diabetes(fasting c-peptide ≤ 0.78ng/dl(or 0.26 nm/l)), secondary diabetes, gestational diabetes 2. insulin therapy modalities containing short or rapid acting insulin (continuous subcutaneous insulin injection, pre-mixed insulin, basal-bolus insulin) 3. history of diabetic ketoacidosis, hyperglycemic hyperosmolar state 4. estimated glomerular filtration rate \<60 ml/min/1.73 m2 5. history of chronic cystitis or recurrent urinary tract infection 6. currently on loop diuretics 7. adrenal insufficiency, pituitary insufficiency 8. currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants) 9. hemoglobin \<10g/dl in female, \<12g/dl in male 10. abnormal liver function (ast/alt \> x3 upper normal limit) 11. on weight loss program or taking weight loss medication 12. nyha class iii, iv congestive heart failure 13. history of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months 14. history of bladder cancer 15. history of malignancy within 5 years 16. pregnant or lactating women 17. history of excessive alcohol abuse (≥30g/day) 18. hypersensitivity to sglt2 inhibitors 19. patient with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption. 20. subject who the investigator deems inappropriate to participate in this study

Keywords: dapagliflozin glucose variability
intensity-modulated radiotherapy protocol in cervix cancer

Conditions: Radiation

Summary: definitive treatment protocol for high-dose intensity-modulated radiotherapy (imrt) with intracavitary radiotherapy in locally advanced cervical cancer: a phase ii trial

radiotherapy 1. intensity-modulated radiotherapy of whole pelvis: 60 gy in 30 fx re-simulation with pelvic magnetic resonance imaging at 46 gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially positron emission tomography-positive), 14 gy in 7 fx 2. intensity-modulated radiotherapy boost of gross cervical tumor or intra-cavitary radiotherapy (icr) * re-staging pelvic magnetic resonance imaging , if complete response occurs intra-cavitary radiotherapy to a point, 25 gy in 5 fx for 2 weeks * re-staging pelvic magnetic resonance imaging i, partial response or stable disease occurs intensity-modulated radiotherapy boost , 10 gy in 4 fx to the gross cervical tumor for 1 week

Eligibility criteria:
inclusion criteria: 1. figo ii-iva patients with untreated and histologically confirmed carcinoma of the uterine cervix 2. patients with eastern cooperative oncology group (ecog) performance status of 0, 1 3. patients with adequate bone marrow function: absolute nutrophil count (anc) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning 4. patients with adequate renal function: creatinine equal to or less than 2.0 mg/ml 5. patients who have signed an approved informed consent and authorization exclusion criteria: 1. patients with recurrent cervical cancer 2. patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer 3. patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node) 4. patients with distant organ metastasis
feasibility of implementing acupuncture into federally qualified health center among breast cancer survivors

Conditions: Breast Cancer

Summary: the purpose of this study is to test the feasibility of implementing acupuncture intervention in federally qualified health centers oncology clinics for breast cancer survivors.

this study has the following specific aims: aim 1: test the feasibility and acceptability of implementing a 5-week acupuncture intervention within federally qualified health center oncology clinic to manage multiple symptoms (pain, hot flashes, fatigue, sleep disturbance, depression, anxiety) among breast cancer survivors receiving endocrine therapy. aim 2: use a mixed methods approach to identify barriers and facilitators associated with implementing acupuncture in federally qualified health center oncology clinic.

Eligibility criteria:
inclusion criteria: * women with histologically confirmed stage 0, i, ii, or iii breast cancer * \> 18 years of old * who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) in the past 1 month and currently taking endocrine therapy * are able to read and speak english * with self-reported pain, fatigue, sleep disturbance, depression, hot flashes and/or anxiety in the last month and their average severity rating ≥ 3 (0-10 numeric rating scale) for at least 3 of the 6 symptoms, and experience at least 2 physical symptoms (pain, fatigue, sleep disturbance). exclusion criteria: * metastatic breast cancer (stage iv) * have a bleeding disorder (e.g. hemophilia, von willebrand's disease, thrombocytopenia) * failure to comply with weekly visits to the acupuncture clinic during the interventional phase of the study * psychiatric or medical disorders which would affect study assessments, such as, dementia, alzheimer's disease, a history of any neurological condition, traumatic brain injury, stroke, and the use of psychotropic medication * breastfeeding, pregnant or are planning get pregnant during the study period
food insecurity, food as medicine, hypertension

Conditions: Food Insecurity; Hypertension

Summary: development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. the study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of hypertension in last 12 months * experiencing food insecurity as indicated by 2-item hunger vital sign * english or spanish speaking * no plans to move from the area for at least 1 year * willing and able to accept text messages * free living to the extent that participant has control over dietary intake * willing and able to provide written informed consent and participate in all study activities. exclusion criteria: * participant in weight research intervention in last 12 months * considering bariatric surgery in the next year or prior bariatric surgery * lack of safe, stable residence and ability to store meals * lack of telephone which can receive text messages * pregnancy/breastfeeding or intended pregnancy in the next year * known drug or alcohol misuse in the past 2 years

Keywords: food as medicine
mediterranean diet and the microbiota gut brain axis in major depression

Conditions: Depression

Summary: the purpose of this study is to assess the efficacy of a mediterranean diet on the function of the vagal nerve in patients with depression.

after being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. subjects meeting the inclusion criteria will be randomized in a group recieiving a mediterranean diet (3 mediterranean meals a day) and dietary coaching (1 session per week for 4 weeks) or a group with conventional hospital food and psychoeducation on depression (1 session per week for 4 weeks).

Eligibility criteria:
inclusion criteria: * legally competent persons aged 18-80 years * diagnosis of depression according to icd-10 or dsm. exclusion criteria: * other neurologic or psychiatric disorders (epilepsy, brain tumor, head injury, head surgery, trauma) * drug or alcohol dependency * acute suicidality * heart disorders, disorders of the circulatory system * pregnancy and period of breastfeeding * severe mental disability, dementia (mmst\<20) * autoimmune disorder, severe immunosuppression (lupus, hiv, multiple sclerosis) * therapy with antibiotics in the last month * chronic laxative abuse * acute infectious diarrhea * gi surgeries (except appendectomy) * regular intake of probiotics, antibiotics and food supplements (1 month before and during the study) * food allergies or other food intolerances which are incompatible with a mediterranean diet * vegetarians, vegans

Keywords: nutrition mediterranean diet vagal function heart rate variability