Kornimate/medical-research-clean huggingface dataset:
pedometer-based walking intervention in patients with chronic heart failure with reduced ejection fraction

Conditions: Systolic Heart Failure

Summary: a multicenter randomized controlled trial, with follow-up at 6 and 12 months. physically inactive participants with chronic heart failure with reduced ejection fraction will be randomly assigned to intervention or control arms. the six-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, monthly face-to-face sessions with the physician, and monthly telephone calls with the research nurse. the intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). the primary outcome is the change in 6-minute walk distance at 6 months. secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and maggic risk score.


Eligibility criteria:
inclusion criteria: 1. diagnosis of heart failure with reduced ejection fraction (left ventricular ejection fraction \<40%) with new york heart association (nyha) class ii or iii symptoms. 2. physically inactive, as determined by a question "as a rule, do you do at least half an hour of moderate or vigorous exercise (such as walking or a sport) on five or more days of the week?". exclusion criteria: 1. signs and symptoms of decompensated heart failure, uncontrolled arrhythmia or effort angina, severe or symptomatic aortic stenosis, persistent hypotension, recent shocks delivered by the automated implantable cardioverter defibrillator. 2. co-morbid conditions that would affect adherence to trial procedures (e.g. inflammatory arthritis, active malignancy, renal disease requiring dialysis, uncontrolled diabetes, major depression or other significant psychiatric disorders, cognitive impairment, significant hearing or visual impairment). 3. major surgery planned within the next 12 months. 4. life expectancy shorter than 12 months. 5. inability to walk from any reason. 6. baseline six-minute walking distance \>450 meters. patients covering more than 450 meters in the baseline six-minute walk test (6mwt) are excluded due to a possible ceiling effect. 7. pregnancy. 8. failure to perform the 6mwt.
optic disc photograph collection study

Conditions: Retina Disease; Glaucoma; Normal

Summary: the objective of this study is to collect stereo-optic disc photographs for potential future analysis.


Eligibility criteria:
inclusion criteria 1. subjects 22 years of age or older on the date of informed consent 2. subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. subjects met inclusion/exclusion criteria for the opt1060 protocol exclusion criteria 1. subjects unable to tolerate ophthalmic imaging 2. subjects not able to obtain acceptable oct, stereo, or optomap images due to ocular media opacity or other reasons
crestor versus placebo in subjects with heart failure

Conditions: Heart Failure

Summary: the purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)


Eligibility criteria:
inclusion criteria: * chronic symptomatic systolic heart failure of ischaemic aetiology as judged by the investigator, optimal therapy for chronic symptomatic systolic heart failure according to the investigator exclusion criteria: * acute myocardial infarction within 6 months before randomization * treatment with any statin or other lipid lowering drug; or a medical condition that in the opinion of the investigator requires treatment with a statin or other lipid lowering drug
short-term perioperative thromboprophylaxis after major abdominal surgery

Conditions: Deep Vein Thrombosis

Summary: major abdominal surgery for cancer is major risk factor for thromboembolism. patients who undergo major abdominal surgery are prone to develop venous thromboembolism, both in the early postoperative period and after hospital discharger. there are strong recommendations in the international guidelines in favor to pharmacological thromboprophylaxis. thus there is no consensus dor the duration of the prophylaxis. there are authors that suggest extended prophylaxis up to 4 week after surgery. on the other hand, there are prospective randomized trials that inpatient (short-term up to 7-10 days) prophylaxis is adequate.

this is a retrospective cohort study with 89 patients who underwent major abdominal surgery for colorectal and gastric cancer. all patients received short term prophylaxis (during hospital stay only) rather than extended prophylaxis (4 weeks). all participants received duplex ultrasound in the study period for the diagnosis of deep vein thrombosis.

Eligibility criteria:
inclusion criteria: * older than 18 * major abdominal surgery gor colorectal or gastric cancer * caprini risk score less than 9 * no history of anticoagulant treatment * thromboprophylaxis during hospital stay only exclusion criteria: * younger than 18 * caprini risk score 9 and above * history of anticogulants * not reachable by phone etc

Keywords: deep vein thrombosis short-term thromboprophylaxis
gastric cancer early detection by multi-dimensional analysis of cfdna

Conditions: Gastric Cancer

Summary: to facilitate the early gastric cancer diagnosis, an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free (cfdna) will be developed and validated.

cancer-related features in cell-free dna (cfdna) fragments have gradually been identified and play essential roles for non-invasive early cancer detection. integrated analysis of several cfdna features have proven to achieve enhanced detection sensitivity as compared to single feature. this study aims to develop and validate a novel blood-based whole methylome sequencing followed with a multi-dimensional model to analyze several features of cfdna for gc early detection. specifically, blood samples will be prospectively collected before gastroscopy. cases and controls will be randomly divided into a training and a testing dataset at a ratio of 2:1. plasma cfdna will be isolated and extracted, followed with a bisulfite-free low-depth whole methylome sequencing. a multi-dimensional model named thorough epigenetic marker integration solution (themis) including methylation, fragmentation, and chromosomal copy number alternation will be constructed in the training dataset. the performance of the model in differentiating cancer patients from non-cancer controls will then be evaluated in the testing dataset.

Eligibility criteria:
inclusion criteria: 1. complete clinical info; 2. patients self-agree to join the study and with signed patient consent and good compliance. the specific inclusion criteria for subjects to be included in the malignant group: 1. according to the definition of ajcc's 8th edition cancer staging manual, patients with gastric adenocarcinoma confirmed by histopathology and with pathological stages of stage i-iv, including patients with esophageal gastric junction adenocarcinoma (egj); 2. has not previously received any local or systematic anti-tumor treatment. exclusion criteria: 1. diagnosed previously with any kind of malignant tumor; 2. have received total or partial gastrectomy; 3. have received bone marrow or organ transplantation; 4. have received blood transfusion in the past 6 months; 5. incomplete clinical info or unqualified to participate in the study.
using reiki therapy to improve symptoms associated with brachytherapy in patients with gynecological malignancies

Conditions: Gynecologic Neoplasm; Brachytherapy; Therapeutic Touch; Endometrial Cancer; Cervical Cancer; Vaginal Cancer; Vulvar Cancer

Summary: the goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. participants will either receive a session of reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. researchers will compare the intervention (reiki therapy) and control (usual care) groups to assess the impact of the reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.


Eligibility criteria:
inclusion criteria: * subject aged ≥ 18 years. * pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva. * eligible to undergo brachytherapy treatment as an outpatient procedure. * able to read and understand english and/or spanish. * able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. * willing to participate in either the reiki therapy or standard of care arm regardless of treatment assignment. exclusion criteria: * prior brachytherapy treatment for a gynecological malignancy. * medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.

Keywords: reiki
development of endothelial biomarkers

Conditions: Metabolic Syndrome

Summary: the main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.

the study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Eligibility criteria:
inclusion criteria: * - 40 to 65 years old * male * non-smokers specific inclusion criteria for healthy subjects : * healthy subjects should not take antihypertensive or statin. * healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated. specific inclusion criteria for subjects with metabolic syndrome : - subjects with metabolic syndrome must have at least 3 of the 5 criteria associated with the metabolic syndrome. exclusion criteria: * treatment vasodilator nitric oxide liberating, * diabetes and coronary artery disease, * chronic alcoholism, * severe hepatic impairment, * end stage renal failure or dialysis, * neurological tremor, * cancer, mental illness or other severe disease which can impact informed consent and / or results, * refusal to be registered in the national file of volunteers * person in exclusion of the national volunteer file

Keywords: endothelium biomarkers atherosclerotic disease endothelial function nutritional stimuli
effect of hyperbaric oxygen therapy on microcirculation

Conditions: Hyperbaric Oxygen Therapy

Summary: previous studies shoes that hyperoxia alters microcirculation.the investigators hypothesize that hyperbaric may restore microcirculation integrity. this hypothesis is supported by a recent study in rabbits, but no data exists for humans. the study will expose fifteen healthy volunteers to a succession of different fraction of inspired oxygen and barometric pressure and assess microcirculatory and macrocirculatory changes via sidestream dark field videomicroscopy, near-infrared spectroscopy, laser doppler, transthoracic echocardiography and bio-impedancemetry at every step.

microcirculation alterations and hyperoxia are known to alter icu-patients' prognostic. studies have shown that hyperoxia alters healthy volunteers' microcirculation, whereas hyperbaric oxygen therapy is commonly used to facilitate cicatrization. there seems to be a paradox. a recent study in rabbits has given some evidences that hyperbaria may restore microcirculation integrity, but to date, there is no such evidences in human. to study hyperoxia and hyperbaric induced changes in micro and macrocirculation, fifteen healthy volunteers will be exposed to successive variations of inspired oxygen fraction and barometric pressure according to a predefine sequence so that only one parameter will change from a condition to the next one : 1. fio2 0.21 - 1 ata 2. fio2 1 - 1 ata 3. fio2 1 - 2.5 ata 4. fio2 0.21 - 2.5 ata 5. fio2 0.21 - 1 ata at each time, and after a 30 minutes period of exposure, measures will be made using sdf-microscopy, laser doppler and nirs to assess microcirculation. as previously described, macrocirculation can modify microcirculation due to a mechanism called hemodynamic coherence. hence, the investigators planned to assess macrocirculation changes at every step of the protocol using bioimpedancemetry and transthoracic echocardiography. each volunteer will be his own control, using the first measurements (condition 1. fio2 0.21 - 1 ata) as reference.

Eligibility criteria:
inclusion criteria: * to provide a medical certificate of fitness to dive (\< 1 year) * consent given for study participation * french health insurance affiliated exclusion criteria: * temporary or definitive contra-indication to dive * pregnancy or \< 18 years of age * precedent dive \< 24 hours * under a legal protection measure * medical history of a disease known to alter microcirculation

Keywords: hyperbaric oxygen therapy normobaric oxygen therapy hyperoxia sidestream dark field videomicroscopy microcirculation
accompanying scientific program for the quality contract prevention of postoperative delirium in the care of older patients (wb-qc-pod)

Conditions: Postoperative Delirium

Summary: in the course of a scientific accompanying program, the project pursues the goal of gaining further insight into a possible connection between various influencing factors and the development of postoperative delirium. against this background, in addition to the primary goal of exploring delirium rates, we aim to identify associations between other secondary end goals like the internal circadian time or the heart rate variability and the occurrence of postoperative delirium. for this purpose, patients of the qc-pod (nct04355195) sample will be studied.

the project aims to improve the understanding of the internal circadian time (chronotype) and other sleep parameters, as well as further secondary end goals, in relation to the development of postoperative delirium. in the course of this the project would like to investigate the perioperative heart rate variability. also, the association of perioperative peripheral cholinesterase activity with perioperative heart rate variability and the development of pod will be explored. additionally, the investigator will analyze the correlation of intraoperative eeg signatures with perioperative heart rate variability, and explore any association of core body temperature and the development of postoperative delirium.

Eligibility criteria:
inclusion criteria: * age ≥ 70 years * male and female patients * patients who have been included in qc-pod * eligible patients\* for inclusion: informed consent by the patient, preoperatively with verbal and written informed consent before the start of data collection * incapacitated patients for inclusion: written informed consent by a legal representative * surgery (elective and not elective) exclusion criteria: * moribund patients (palliative situation) * insufficient knowledge of the german language * cardiac arrhythmia (e.g. atrial fibrillation) * presence of a pacemaker * condition after heart transplantation * inflammation in the area of the frontal sinus
a modified technique to facilitate pealing of the rectal mucosa in delorme operation

Conditions: Rectal Prolapse

Summary: the aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .

in classic delorme operation stripping of the mucosa done and this is associated with extensive bleeding in addition to the time consumed in this step.the new modification done by the investigator replace this step with another associated with less intraoperative bleeding and not time consuming.

Eligibility criteria:
inclusion criteria: * mild to moderate rectal prolapse * singed informed consent. exclusion criteria: * huge rectal prolapse . * recurrent rectal prolapse

Keywords: recta prolapse intraoperative bleeding mucosal cauterization
a multi-center, prospective, single-blind, controlled trial comparing diagnostic value of different eus-fna techniques

Conditions: Neoplasms; Infection; Inflammation; Lymphoma; Cancer; Sarcoid; Mass Lesion

Summary: the aim of this study is to compare endoscopic ultrasound guided-fine needle aspiration (eus-fna) with a standard 22-gauge needle using "standard suction", "slow-pull" and "wet suction" for thoracic/abdominal solid/solid-cystic lesions. investigators intend to compare the effectiveness and safety of the three methods in order to discover the optimized technique for obtaining diagnostic material and making accurate diagnosis.


Eligibility criteria:
inclusion criteria: * in-patients and out-patients between the age of 18years and 80 years with thoracic/abdominal solid/solid-cystic lesions for eus-fna. exclusion criteria: * uncorrectable coagulopathy (inr \> 1.5) * uncorrectable thrombocytopenia (platelet \< 50,000) * cystic lesions * inaccessible lesions to eus * contraindications for conscious sedation * uncooperative patients * refusal to consent form

Keywords: eus-fna
pilot study of the safety and efficacy of anakinra (recombinant human interleukin-1 receptor antagonist) in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: this is an open-label non-randomized, pilot study to evaluate the effect of interleukin-1 blockade on exercise capacity in patients with pulmonary hypertension. subjects will undergo cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with anakinra (recombinant human interleukin-1 receptor antagonist.


Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of pah (from prior right heart catheterization), with functional class iii symptoms of right ventricle failure despite optimal pah therapy * mean pulmonary artery pressure \>25 mmhg * pulmonary capillary wedge pressure \<15 mmhg * pulmonary vascular resistance \>3 wood units exclusion criteria: * pah due to connective tissue disease (including scleroderma), interstitial lung disease (total lung capacity \<65% predicted value), or cirrhosis (portopulmonary hypertension) * angina or electrocardiograph (ecg) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ecg changes that limit the ability to detect ischemia (i.e. left bundle-branch block). * recent (\<14 days) use of anti-inflammatory drugs (not including nsaids), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study * severe kidney dysfunction (egfr \<30 ml/min) * thrombocytopenia (\<50,000/mm3), or neutropenia (absolute neutrophil count \<1,500/mm3) * refusal by a woman of childbearing potential (not post-menopausal or surgically sterile) to use a medically acceptable form of birth control (including, but not limited to, a diaphragm, an intrauterine device (iud), progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom) throughout the duration of the study * history of hypersensitivity to anakinra or e. coli products * latex or rubber allergy * inability to give informed consent
administration of antibiotic prophylaxis for transperineal prostate biopsy in cipto mangunkusumo hospital

Conditions: Prostate Cancer; Prostate Biopsy; Perioperative Complication; Bacteriuria; Urinary Tract Infections; Sepsis

Summary: this randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo. the types of infection studied included bacteriuria, urinary tract infection (uti), uti with fever (febrile uti), and sepsis. this study hypothesized that the administration of prophylactic antibiotics during transperineal prostate biopsy would result in lower rates of perioperative infection complications.

prostate cancer screenings will be conducted in all patients aged \>45 years with lower urinary tract symptoms (luts) through psa test and digital rectal examination (dre). those with psa levels of 4.0 ng/ml or higher or other abnormal findings on dre will be recommended to undergo transperineal prostate biopsy. in addition, participants will be offered to participate in this clinical trial, in which participants will be randomly assigned into two groups: one group will receive prophylactic antibiotic, while the other group will receive placebo. the randomization process will be conducted before the biopsy procedure. computers will generate random numbers, which will put the participants into two groups. these numbers can only be accessed by the research monitor (clinical research supporting unit of imeri fmui), while the investigators, surgeons, residents, and nurses involved will be blinded to this information. to ensure patient blinding, the placebo and cotrimoxazole forte 960 mg will be reformed as identical as possible in capsule preparation. the primary outcomes of this clinical trial are the rate of perioperative infection complications, including bacteriuria, urinary tract infection (uti), uti with fever (febrile uti), and sepsis, in 24 hours, 7 days, and 14 days postoperatively. the secondary outcomes of this clinical trial are the rate of readmission.

Eligibility criteria:
inclusion criteria: * patient with lower urinary tract symptoms aged \>45 years with either psa levels of 4.0 ng/ml or higher or abnormal findings on digital rectal examination (dre) * patient with a negative initial urine culture / urinalysis test exclusion criteria: * patients who refuses to undergo transperineal prostate biopsy * patients who refuses to participate in the research * patient who is unable to communicate effectively * patient with a documented history of cotrimoxazole allergy * patient who has consumed antibiotics for other indications prior to undergoing prostate biopsy * patient with urinary tract infection symptoms prior to undergoing prostate biopsy * patient with a history of immunodeficiency disorders or long-term corticosteroid use * patient with a history of prostate cancer * patient with a history of prior prostate biopsy

Keywords: antibiotic prophylaxis transperineal prostate biopsy randomized controlled trial
airway resistance measurement in children 3 to 6 years of age

Conditions: Airway Obstruction

Summary: in preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (rint) and plethysmographic measure of specific airway resistance (sraw). even if rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sraw seems to be better for discriminating airway obstruction. these two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.


Eligibility criteria:
inclusion criteria: * child 3 to 6 years aged exclusion criteria: * height below 90 centimeters * opposition to participation