Kornimate/medical-research-clean huggingface dataset:
stable sleep pattern before sleep loss

Conditions: Sleep

Summary: sleep is now recognized as important for disease prevention. too little or too much sleep contributes to cardiovascular disease. leading health organizations recommend adults sleep 7-9 hours per night for optimal health. this recommendation is based on research that finds reductions in sleep duration elevate blood pressure and impair vasodilation of blood vessels. one question raised in a recent nih workshop report (pmid:36448463) is whether stable sleep patterns, irrespective of a person's sleep duration, could mitigate the adverse effects of insufficient sleep on vascular function. this project will address this question in midlife adults using a randomized, crossover designed study.

purpose and hypothesis the aim of this study will be to test the hypothesis that stable sleep, as defined by a consistent (low variability) bedtime and wake-time schedule, will diminish the negative effect of sleep deprivation on vascular function. study design and procedures thirty adults (15 men, 15 women) will complete a 6-week study that will involve five study visits. the first visit will include informed consent, collection of demographic data, sleep- and health-related surveys, and familiarization with study procedures. participants will then be block randomized to either habitual sleep followed by stable sleep, or stable sleep followed by habitual sleep - each sleep condition will lasts two weeks. in the habitual sleep condition, participants will be asked to follow their normal routine without concern about their sleep duration. in the stable sleep condition, participants will be asked to keep the same bedtime and wake-time schedule without deviation. bedtime and wake-times will be determined by the researchers, but individualized for each participant so that their usual sleep duration (based on self-report) is met. sleep will be monitored throughout the study using research-grade motion sensors worn at the wrist. resting blood pressure, blood vessel vasodilatory function, and cardiovascular responses to exercise will be our main outcome variables. these variables will be measured before (on day #13) and after (on day #14) one night of sleep deprivation. total sleep deprivation is a well-established experimental model to understand the acute effects of insufficient sleep on vascular function in humans.

Eligibility criteria:
inclusion criteria: * women and men * 35-64 years of age exclusion criteria: * obese based on bmi \>29 kg/m2 * night-shift work * prior diagnosis of sleep apnea * signs of insomnia using the insomnia symptom questionnaire * a 'poor sleeper' (global score ≥5) based on the pittsburgh sleep quality index * taking medications that alter sleep * personal history of stroke, coronary heart disease, diabetes mellitus * taking antihypertensive medications * smoker (including vaping)

Keywords: sleep variability blood pressure sleep deprivation vasodilation
ureteroscopic laser modality on total lasing time and total energy in patients with large, dense renal calculi

Conditions: Renal Calculi

Summary: this study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean hounsfield units of 1000 or more.

this study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean hounsfield units of 1000 or more. additionally, we will observe the impact of these parameters on total operative time.

Eligibility criteria:
inclusion criteria: * adults between the ages of 18-80. * any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure. * must be suitable for a flexible ureteroscopy as determined by the md * large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm * an average stone density of at least 1000 hounsfield units. exclusion criteria: * those with a stone burden less than 10mm or more than 20mm. * those with an average stone density below 1000 hounsfield units. * patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery * patients that cannot undergo ureteral access sheath placement * patients with abnormal anatomy such as horseshoe kidney * patients with a history of: * ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi * ipsilateral ureteral strictures * prior radiotherapy of the abdomen or pelvis * neurogenic bladder * spinal cord injuries * those who are pregnant * currently being treated for infection or cancer
pk-directed dose adjustment of iv busulfan conditioning regimen for autologous stem cell transplant in lymphoma patients

Conditions: Lymphoma

Summary: this is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat non-hodgkin or hodgkin's lymphoma.

evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with nhl and hl receiving an iv busulfan-based conditioning regimen with pk-guided iv busulfan dosing, followed by autologous hsct as well as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (beam) conditioning regimen (and its variants) obtained from registry data in the center for international blood and marrow transplant research (cibmtr) assessment of the safety profile of a bucye conditioning regimen with pk-directed dosing of iv busulfan will also be completed.

Eligibility criteria:
inclusion criteria: subjects with nhl to be included: * any subject with nhl that had relapsed or progressed following initial therapy with an anthracycline-based chemotherapy regimen and has achieved a subsequent partial remission (pr) or a complete remission (cr) following a salvage chemotherapy regimen. * any subject with nhl that was initially refractory to an anthracycline-based chemotherapy regimen but who has achieved a pr or cr following a salvage chemotherapy regimen. * any subject with an initial international prognostic index (ipi) score 4-5 who achieved a pr or any cr following an anthracycline-based chemotherapy regimen except subjects with mantle cell, t cell and natural killer (nk) cell pathologies. * subjects with mantle cell, t cell and nk cell lymphoma may be enrolled if they have pr or cr after initial therapy. * any subject that has relapsed or progressed following previous autologous hsct. subjects with hl to be included: * any subject with hl that had relapsed or progressed following initial therapy with an multi-drug chemotherapy regimen and has achieved a subsequent pr or a cr following a salvage chemotherapy regimen. * any subject with hl that is initially refractory to a multi-drug chemotherapy regimen but who has achieved a pr or cr following a salvage chemotherapy regimen. * any subject that has relapsed or progressed following previous autologous hsct. exclusion criteria: * any subject with chemoresistant disease by demonstration of less than pr to most recent chemotherapy, and any subject with prior treatment history of autologous hsct or high-dose chemotherapy with stem cell rescue for any medical reason will be excluded. excluded will also be subjects with existing or active central nervous system lymphoma or human immunodeficiency virus related lymphoma, unacceptable organ function, or uncontrolled infections.

Keywords: hodgkin lymphoma non-hodgkin's lymphoma bone marrow transplant stem cell transplant busulfan cyclophosphamide etoposide
vegf gene transfer for diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: this gene therapy study is being conducted to evaluate intramuscular gene transfer using vegf (vascular endothelial growth factor) in patients with diabetic neuropathy in the legs. this condition causes a decrease in feeling and sensation due to diabetes. vegf is dna, or genetic material that is injected into the muscles of the leg. once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.


Eligibility criteria:
inclusion criteria: to be eligible to enroll and remain in the study, patients must meet the following criteria: * be at least 21 years old. * have type i or type ii diabetes mellitus and require oral anti-hyperglycemic agents or insulin. * have peripheral neuropathy related to diabetes. exclusion criteria patients are to be excluded from the trial if any of the following conditions are met: * have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.

Keywords: diabetes mellitus neuropathy peripheral artery disease
surgical septal myectomy vs percutaneous transluminal alcohol septal ablation in patients with hypertrophic obstructive cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: the aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (asa) or surgical septal myectomy (ssm).

this is a prospective, multicentre, open label, randomized controlled, non-inferiority trial (rct) with a 1:1 randomization to alcohol septal ablation or surgical septal myectomy in patients with hypertrophic obstructive cardiomyopathy (hocm) between 40-75 year of age with symptoms and/or syncope due to hocm despite medical therapy. a total of 100 patients will be included. all patients will be evaluated with bicycle ergometry exercise test, mri and 2d-echo before and 1 year after invasive treatment. follow-up will be at 1,3 and 5 years.

Eligibility criteria:
inclusion criteria: 1. age between 40-75 years including 40 and 75 years of age 2. hocm eligible for both ssm and asa by a heart team (multidisciplinary team) and core lab. 3. left ventricle outflow tract (lvot) obstruction \> 30mmhg at rest or during physiological provocation by transthoracic echocardiogram 4. symptomatic (new york heart association classification (nyha) \>1 or canadian cardiovascular society (ccs) class \>1) and/or syncope due to hocm exclusion criteria: 1. unable to give informed consent 2. a life expectancy of less than 1 year 3. concomitant (structural valve disease, aorta, rhythm, cabg) surgery during the same session 4. not able to perform bicycle ergometry exercise test
a safety and efficacy study evaluating dimebon (latrepirdine) in patients with moderate to severe alzheimer's disease

Conditions: Moderate to Severe Alzheimer

Summary: the purpose of this study is to determine if dimebon is safe and effective in patients with moderate to severe alzheimer's disease.


Eligibility criteria:
inclusion criteria: * moderate-to-severe alzheimer's disease * mini-mental state examination (mmse) score between 5 to 14, inclusive * stable on donepezil for at least 6 months exclusion criteria: * other causes of dementia * major structural brain disease * unstable medical condition or significant hepatic or renal disease
augmentation of meniscal repair with marrow stimulation techniques (microfractures)

Conditions: Meniscus Lesion

Summary: this study will compare meniscal healing augmented or without augmentation with bone marrow stimulation techniques the assessments will include validated, disease specific, patient oriented outcome measures, second look arthroscopy during second step acl reconstruction. results of this study will help ascertain whether microfractures improve meniscal healing rates.

the role of meniscal in the knee integrity is pivotal and lack or partial role of the meniscus increases rate of joint degeneration. partial meniscal removal is the most popular procedure and meniscal repair remain in minority of arthroscopic surgeries. as criteria of inclusion to meniscal repair are very rough, still success rates of meniscal repair remain in the 60-80% range for isolated repairs. this rate is greater when performed with acl reconstruction. we believe that augmentation with bone marrow stimulation techniques will induce more complete and possibly faster healing.

Eligibility criteria:
inclusion criteria: * complete vertical longitudinal tear \> 10 mm in length * tear located in the vascular portion of the meniscus, only in red-white zone * unstable peripheral tear * single tear of the medial and/or lateral meniscus * meniscal injury 1 -18 month prior surgery * planned second step arthroscopy (acl reconstruction) * skeletally mature patients 18-55 years of age exclusion criteria: * discoid meniscus * arthritic changes (kellgren lawrence scale \>2) * non repairable meniscus * degenerative or presence of crystals in meniscus * concomitant procedure (acl reconstruction, microfracturing, trephination) * inflammatory diseases (i.e. rheumatoid arthritis)

Keywords: meniscus repair bone marrow stimulation
a phase iii study of nk105 in patients with breast cancer

Conditions: Breast Cancer Nos Metastatic Recurrent

Summary: to verify the non-inferiority of nk105, a paclitaxel-incorporating micellar nanoparticle, to paclitaxel in terms of the progression-free survival in patients with metastatic or recurrent breast cancer.

this study is a randomized, open-label, multi-national phase iii study.

Eligibility criteria:
inclusion criteria: * written informed consent of the patient signed by herself. * histologically confirmed metastatic or recurrent adenocarcinoma of the breast. * aged 20 to 74 at the time of informed consent. exclusion criteria: * prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer.

Keywords: nk105, paclitaxel, breast cancer, micelle
drug use investigation of selara tablets (an investigation for chronic heart failure)

Conditions: Chronic Heart Failure

Summary: secondary data collection study; safety and effectiveness of selara under japanese medical practice

this study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. the patients will be observed up until week 52.

Eligibility criteria:
inclusion criteria: * patients in whom treatment with this drug is for chf. the indications at approval for this drug are as follows. when using this drug, refer to the latest package insert of this drug. exclusion criteria: * patients who were previously registered for this study. patients who received eplerenone within the past three months regardless of the reason for use.

Keywords: selara chronic heart failure
effect of thoracic epidural anesthesia on left ventricular functions: a strain echocardiography study

Conditions: Thoracal Epidural Block; Echocardiography

Summary: post-thoracic surgery pain management thoracic epidural catheter is the most commonly used method. thoracic epidural anesthesia, in which cardiac sympathetic nerves (t1-t5) are involved in neural blockade, is the focus of our research. many studies have shown a decrease in inotropic status (intrinsic function) after blockade of cardiac sympathetic innervation with thoracic epidural anesthesia (tea).we want to examine the cardiac effects of tea with strain echocardiography, which is an advanced echocardiography method. therefore, we aimed to investigate the effect of tea on left ventricular functions with strain echocardiography.

the study was designed as an observational study. our study will be conducted for 12 months after receiving ethical committee approval. 23 patients are planned to be included in the study. tte will be performed when the patients arrive at the preoperative room for the operation. then, thoracic epidural anesthesia will be performed. after the block, all usual medications, except ace inhibitors, will be continued according to hospital protocol for 15 days of surgery. patients will be given up to 2 mg midazolam and 7 ml/kg 0.5% isotonic 15 minutes before the epidural catheter is administered. a tte will be performed before the epidural catheter is placed. after appropriate local anesthesia, the epidural catheter will be placed while the patient is in a sitting position. the puncture will be performed between t6-t7 and t8-t9 using the midline approach with the "loss of resistance" technique. the catheter will be inserted 3-4 cm into the epidural space and an epidural lidocaine bolus (10 ml at 2% concentration) will be administered while the patients are in the supine position. tte will be performed again after 15 minutes. at these stages, hemodynamic values will also be recorded. we want to examine the cardiac effects of tea with strain echocardiography, which is an advanced echocardiography method. therefore, we aimed to investigate the effect of tea on left ventricular functions with strain echocardiography.

Eligibility criteria:
inclusion criteria: elective payment options asa i-iii ages 18-75 exclusion criteria: 1. refusal at enrollment 2. request for withdrawal from the study 3. inability to give informed consent 4. emergency surgery 5. bleeding diathesis 6. presence of contraindications to the la agents used in this study 7. use of chronic opioids 8. psychiatric disorders 9. presence of infection at the injection site

Keywords: thoracic epidural anesthesia left ventricle strain echocardiography cardiac function
impact of the lack of cmv-specific cd8+ t cell response in cmv-seropositive donors in cmv reactivation after hematopoietic stem cells transplant in cmv-seropositive recipients

Conditions: Cytomegalovirus Infection; HSCT

Summary: donor and recipient cmv-serostatus is one of the risk factor for cmv infection in solid organ transplantation. recipients with igg positive anti-cmv are classified as low-risk patients since it is considered that patients also have specific cellular immunity against cmv. however, investigators group has published that around 25% of solid organ transplant candidates lack cmv-specific cd8+ t-cell response ("humoral/cellular mismatch") and they are at a higher risk of cmv replication after transplantation. the main goal of this study is to analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell transplantation (hsct) cmv-seropositive donors on the cmv reactivation after hsct in cmvseropositive recipients. investigators will study not only the incidence of cmv reactivation but also the severity (duration and peak viral load), cmv disease and survival. cmv-seropositive patients who receive a hsct (bone marrow or peripheral blood) from related donors will be consecutively recruited from reina sofía hospital (córdoba) and marqués de valdecilla hospital (santander). patients will be monitored during 12 months after hsct. cmv-specific cd8+ t-cell response will be determined in their donors, using quantiferon-cmv assay, to know the frequency of humoral/cellular mismatch. innate and adaptive immune reconstitution will be assessed by flow cytometry and experimental quantiferon monitor assay. cmv-specific cd8+ t-cell reconstitution will be determined using quantiferon-cmv assay.


Eligibility criteria:
inclusion criteria: 1. cmv seropositive patients who receive a hsct (bone marrow or peripheral) blood from related donors 2. \>14 years old 3. signed inform consent form exclusion criteria: 1. hiv, hcv, hbv infection

Keywords: stem cells transplantation cytomegalovirus infection cmv-specific immune response immune reconstitution humoral/cellular mismatch interferon-gamma
supplemental thyroxine treatment for preterm infants with hypothyroxinemia

Conditions: Hypothyroxinemia

Summary: in order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for vlbw infant with hypothyroxinemia during the first month of age is conducted.

a prospective randomized unmasked controlled trial is conducted. newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.

Eligibility criteria:
inclusion criteria: * birth weight: less than 1500g * gestation: 22 weeks 0 day ≤ * serum free thyroxine level lower than 0.8 ng/dl * serum thyrotropin lower than 10 μu/ml * age of between 2 and 4 weeks after birth * informed consent exclusion criteria: * any known thyroid disease in mother

Keywords: very low birth weight infant hypothyroxinemia outcomes
effects of exercise in the functional capacity, central artery and rigidity ankle brachial index

Conditions: Peripheral Arterial Disease

Summary: the peripheral arterial disease prevalence is around 3-10 % of the world population. exercise plays an important role in treating these patients.

objective: to investigate the effects of training combined aerobic - strength versus aerobic functional capacity, ankle brachial index (abi ) and central arterial stiffness in patients with peripheral arterial disease

Eligibility criteria:
inclusion criteria: * diagnosis of dap and ci . * stage i or ii of fontaine . * intermittent claudication symptoms for at least 3 months with ankle brachial index (abi ) at rest ≤ 0.90 in 1 or 2 legs. exclusion criteria: * ischemia criticism in one of the lower limbs. * moderate or severe ulcers on one of the lower limbs.orthopedic issues that prevent pratical of the exercises or conducting evaluations . * participation in other studies with rehabilitation. * decompensated hypertension . * decompensated diabetes . * cardiovascular events less than three months . * severe lung disease .

Keywords: peripheral arterial disease, exercise
impact of zinc and vitamin d3 supplementation on the survival of aged patients infected with covid-19

Conditions: SARS-CoV 2

Summary: mortality from covid-19 increases with age, reaching 14.8% from the age of 80. the severity of the infection is linked to the acute respiratory distress syndrome (ards) which requires intensive care. ards is the consequence of the reactional inflammatory storm that damages the lungs. aged subjects are particularly prone to zinc and vitamin d deficiency. these two micronutrients are able to modulate the immune response by reducing the inflammatory storm. the hypothesis is that supplementation with zinc and vitamin d would reduce the inflammatory reaction which worsens ards and leads to the death of subjects infected with covid-19.


Eligibility criteria:
inclusion criteria: * institutionalized exclusion criteria: * life expectancy \< 1 month independently of covid-19 infection (overall subjects) * known hypercalcemia * history of renal lithiasis

Keywords: survival covid-19 aged subjects zinc 25-oh cholecalciferol