Kornimate/medical-research-clean huggingface dataset:
99mtc-psma-i&s biodistribution in patients with prostate cancer

Conditions: Prostate Carcinoma; Recurrent Prostate Carcinoma

Summary: this exploratory study conducted under the rdrc program studies the biodistribution of 99mtc-psma-i\&s in patients with prostate cancer who undergo pelvic lymph node dissection. prostate specific membrane antigen (psma)-targeted radio-guided surgery uses the preoperative intravenous administration of a psma-ligand called psma-imaging and surgery (i\&s) labeled with the gamma-emitter radioisotope technetium-99m (99mtc). giving 99mtc-psma-i\&s may detect psma-expressing lymph nodes during surgery using a gamma probe and may help guide doctors to detect prostate cancer that has spread to the lymph nodes.

primary objective: i. to define the biodistribution of 99mtc-based psma imaging and surgery agent (99mtc-psma-i\&s) in normal and malignant tissues of patients with prostate cancer (pca) with histopathology validation, when available. secondary objectives: i. to correlate the 99mtc-psma-i\&s accumulation within tumor lesions observed by in-vivo single-photon emission computed tomography (spect), ex-vivo gamma measurements and level of prostate-specific membrane antigen (psma) expression quantified by histopathology, when available. ii. to define the best time-point for radio-guided surgery (rgs) with the highest tumor-to-background ratio following 99mtc-psma-i\&s administration. outline: the first 5 patients receive an initial dose of 99mtc-psma-i\&s intravenously (iv) followed by 5 spect/ct scans at 3-5, 5-20, 17-21, 25-29, and 40-46 hours later. these 5 patients then receive a second dose of 99mtc-psma-i\&s iv and then undergo standard of care surgery. all subsequent patients receive one dose of 99mtc-psma-i\&s iv before surgery.

Eligibility criteria:
inclusion criteria: * men with pca (primary or recurrent disease) * men who received a 68ga-psma-11 positron emission tomography (pet)/computed tomography (ct) for staging or restaging * men with evidence of lymph nodes (lns)-positive disease on 68ga-psma-11 pet/ct * men who are scheduled for pelvic ln dissection (plnd) * men who can provide oral and written informed consent * men who can comply with study procedures exclusion criteria: * patients who started any pca treatment between study enrollment and surgery * technically inaccessible nodal location
regional database for collecting clinical-biological and imaging data "secondary bone oncology and bone localizations of hematologic diseases"

Conditions: Bone Metastases

Summary: improving the effectiveness of cancer treatments makes it possible to lengthen patient survival. it is therefore important to ensure that the quality of life is also maintained by reducing pain and handicap. some cancers tend to spread to the bone. the bone locations of cancer can weaken the bone and lead to complications such as fractures, pain, or compression of neurological structures. to avoid such complications, weekly multidisciplinary meetings (mm) bring together specialists (oncologists, rheumatologists, cancer surgeons, radiologists, radiotherapists, etc.) to discuss the files of patients with bone lesions from cancer. they offer specific treatments adapted to each patient to treat or reduce the risk of complications. the oosloh study aims to collect clinical, biological, and imaging data from patients for whom a discussion took place in bone dedicated mm. based on these data, epidemiological studies could be carried out to better understand the clinical factors leading cancer to colonize bone. but also to determine the factors making it possible to prevent or better treat bone complications and improve the quality of life of patients. this study does not require any examinations or additional visits to the patient


Eligibility criteria:
inclusion criteria: * patient aged 18 or over, * patient whose file is presented to the oosloh mm and who has not objected to the use of his non-nominative clinical, biological and imaging data * social insured patient exclusion criteria: * patient who died before presentation to oosloh mm, * minor patient, * patient objecting to the use of their data for research purposes, * patient unable to express his right to object to his participation in the study.

Keywords: bone localisations of haematological diseases cancer bone metastasis haematological diseases quality of life epidemiological data
adaptation dose of enoxaparin in moderate renal failure patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome; Renal Failure

Summary: the objective of the valide study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti xa level in plasma compared to that obtained in patients without renal failure and receiving the usual dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be included.

included patients will be those hospitalized for an acute coronary syndrome with indication of enoxaparin treatment. a same initial dose of 1 mg/kg will be administrated to all patients. according to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min. after the fourth dose, the anti-xa plasma levels (main endpoint) will be measured at peak (between 3 and 5 hours after dose administration). residual values of antixa will also be measured before the fifth dose administration (secondary criteria). the objective is to demonstrate a bio-equivalence of efficacy on the anti-xa values obtained in patients with moderate rela failure compared with patients with creatinine clearance higher than 50 ml/min. thrombotic and bleeding events will be recorded during hospitalisation. 140 per-protocol evaluable consecutive patients will have to be obtained: 70 with creatinine clearance higher than 50 ml/min and 70 patients with creatinin clearance between 30 and 50 ml/min.

Eligibility criteria:
inclusion criteria: * patients hospitalized for acute coronary syndrome * indication of enoxaparin treatment * informed consent exclusion criteria: * myocardial infarction with st elevation * inclusion later than 12 hours after the first enoxaparin dose administration * creatinine clearance lower than 30 ml/min * history of thrombopenia induced by heparin * platelet count lower than 100.000 / mm3 * age \< 18 * pregnancy * history of hemorrhagic stroke * contra-indication to enoxaparin

Keywords: enoxaparine acute coronary syndrome renal failure dose adaptation
substance use and fitness

Conditions: Substance Abuse; Exercise

Summary: the purpose of this pilot study is to estimate the effect size of a contingency management procedure that reinforces walking at rates consistent with the american college of sports medicine recommendations of 10,000 or more steps per day in older adults. we expect that participants randomized to the contingency management intervention will increase walking to a greater degree than those assigned to a standard care condition.


Eligibility criteria:
inclusion criteria: * age 55 - 75 years * currently not physically active * willing and physically able as determined by physician approval to walk 10,000 steps per day * blood pressure of 120-159 mmhg systolic or 80-99 mmhg diastolic * willing to meet with research staff weekly for 12 weeks exclusion criteria: * psychiatric or physical illness that could interfere with participation
lars for chinese patients

Conditions: Incidence and Risk Factors of Low Anterior Resection Syndrome

Summary: low anterior resection syndrome (lars) frequently occurs in patients undergoing low anterior resection (lar). however, the incidence, exact mechanism and risk factors of major lars largely variate in different studies. considering varieties and differences of patient characteristics between chinese patients and the western ones, this retrospective study aims to investigate the incidence of lars in chinese patients undergoing laparoscopic lar, and to explore perioperative risk factors that might be associated with major lars. consequent patients undergoing laparoscopic lar and free from disease recurrence from january 2015 to may 2021 were issued with lars questionnaire. incidence of lars and patient data were collected and analyzed.


Eligibility criteria:
inclusion criteria: patients diagnosed as rectal cancer and underwent radical laparoscopic lar and straight colorectal/coloanal anastomosis (with or without a protective stoma) by a same surgical team exclusion criteria: either local or distal recurrence, severe complications such as postoperative anastomotic leakage, failure of protective stoma closure, data missed and no responding to lars questionnaire
inhaled mometasone to reduce painful episodes in patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the proposed research is designed to test the global hypothesis that inhaled corticosteroids (ics), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in adults with sickle cell disease (scd) who wheeze, but do not meet criteria for a diagnosis of asthma. the specific aims of this proposal are 1) conduct a feasibility study - a randomized controlled trial of ics for adults with scd who do not meet criteria for a diagnosis of asthma but report recurrent cough or wheezing, 2) measure the effects of ics on biological correlates of pulmonary inflammation (as determined by exhaled nitric oxide) and vascular injury (as determined by svcam) in scd, and 3) compare properties of traditional and bayesian adaptive clinical trial design for therapeutic trials in scd in preparation for designing a definitive trial of ics. these aims have the potential to 1) change the standard of care for individuals with scd and recurrent cough or wheeze, 2) provide insight into the pathogenesis of non-asthmatic wheezing in scd and its response to treatment, 3) explore the suitability of innovative clinical trial designs to overcome the challenges that have hindered therapeutic innovation for scd.


Eligibility criteria:
inclusion criteria: * age 15 or older * sever scd phenotypes (hb ss and sβthalassemia0) * a positive response to cough/wheeze questions exclusion criteria: * patient carries a physician diagnosis of asthma * patient is prescribed asthma medications * patient is currently having a painful crisis (as defined by validated pain diary questions) * patient has acute respiratory symptoms * known hypersensitivity to milk proteins * meets criteria for our operational diagnosis of asthma * more than 15 ed visits for pain over the preceding 12 months * admitted or discharged from the hospital for scd pain within the last 7 days

Keywords: sickle cell disease pain crisis painful crisis sickle pain
the effect of β-carotene, vitamin d3 and zinc on hyaline membrane disease and feeding intolerance in premature neonates

Conditions: Hyaline Membrane Disease; Necrotizing Enterocolitis of Newborn

Summary: hyaline membrane disease, now commonly called respiratory distress syndrome (rds), and feeding intolerance, which can lead to necrotizing enterocolitis (nec), are two key morbidities found in premature neonates which resulted in high mortality rate in indonesia. cochrane meta-analysis proved that antenatal steroid therapy can reduce the morbidity and mortality rate of premature neonates. but there is still different outcomes and severity of disease in preterm newborn receiving the same dose of antenatal steroid therapy. this raises questions whether there are other factors influencing the development and maturity of lung and gut in preterm newborn, aside from steroid therapy. vitamin a, d and zinc are already known for their function in fetal lung and gut development. to our best of knowledge, no study has evaluated the effect of these vitamins levels on hmd and feeding intolerance in premature neonates. therefore, the aim of this study want to evaluate the effect of antenatal steroid therapy versus co-administered β-carotene, vitamin d3, zinc and antenatal steroid therapy on the presence and severity of hmd and feeding intolerance in premature neonates.

this study is a randomized controlled trial and held in cipto mangunkusumo hospital. pregnant women 28-34 weeks of gestational age, who fulfill the inclusion criteria, divide into two groups. subjects from both groups receive the hospital protocol of preterm birth, 4 doses of 6 mg of dexamethasone, intravenous 12 hours apart to support lung maturation. subjects in intervention group receive oral single-dose beta-carotene 25,000 iu, oral single-dose vitamin d3 50,000 iu and oral zinc 50 mg/day for 3 days. the maternal dan cord blood sample are obtained for zinc, vitamin a and 25(oh)d levels before and after intervention. after the premature neonates was born, observation will be done for maximum period of 4 weeks. the presence and severity of hmd and feeding intolerance or nec will be recorded. neonates showing any signs of hmd and/or abdominal distension will need to undergo additional chest/abdominal x-ray procedures.

Eligibility criteria:
inclusion criteria: * pregnant women who has preterm birth in 28-34 weeks gestational age exclusion criteria: * multiple pregnancy * drug allergy * fetal congenital malformation * maternal gestational diabetes mellitus
visuall field analyzer (vfa) compared to standard humphrey automated perimetry

Conditions: Glaucoma, Open-Angle

Summary: to determine age-adjusted reference values of the visuall field analyzer (vfa) retinal sensitivity and to assess the repeatability of the measured values and compare them with those measured by a standard automatic perimetry (sap).

standard automatic perimetry (sap) is the gold standard test for the evaluation of central and peripheral retinal sensitivity to light for detection and monitoring optic nerve diseases such as glaucoma. the current device has its own limitation such as positioning for the duration of the test which makes is hard for older patients especially those with back or other musculoskeletal diseases, artifact of the corrective lenses used to accommodate the patients refractive errors, etc. several devices have been developed since the advent of the octopus perimeter 3-5 and the humphrey field analyzer (hfa), in an effort to improve the test reliability and patient comfort. the main goal of this study is to evaluate the repeatability of a novel psychophysical platform that takes advantage of a head mounted device (hmd) with eye tracking capabilities. other objectives of this study include the development of an initial reference database and comparison of the measured parameters with hfa.

Eligibility criteria:
inclusion criteria: * age 21 to 80 years * healthy subjects with no eye diseases, normal appearing optic nerve and retina, intraocular pressure less than 19 millimeters mercury and normal standard automatic perimetry (sap). * mild glaucoma subjects with less than -6 mean deviation * moderate glaucoma subjects with -6 to -12 mean deviation exclusion criteria: * spherical refraction outside ± 3.0 diopters and cylinder correction outside 2.0 diopters * unreliable sap (false positives, fixation losses and false negatives greater than 25% and/or observable testing artifacts) * unreliable visuall field analyzer (vfa) (greater than 25% false positive, excessive fixation losses) * sap abnormality with pattern loss consistent with neurologic and/or other ocular diseases than glaucoma * intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 6 months before enrollment and without posterior capsule opacification) * history of systemic condition known to affect visual function * history of medication known to affect visual function

Keywords: open angle glaucoma visual field standard automatic perimetry
prognostic value of clinical and biological factors in patients with refractory/relapsed diffuse large b-cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: the purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed diffuse large b-cell lymphoma.

the main aim of this study is to compare the prognostic value of r-ipi at diagnosis and relapse, relating it with the obtained response after second line

Eligibility criteria:
* age 18 \> years old * patients with refractory/relapsed diffuse large b-cell lymphoma after first line treatment with rituximab, with or without transplantation. patients must have finished a rescue treatment including rituximab * ability to understand and willingness to sign a written informed consent

Keywords: diffuse large b-cell lymphoma r-ipi
treatment of stress urinary incontinence in women with autologous adipose-derived mesenchymal stem cells

Conditions: Stress Urinary Incontinence

Summary: treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

during the implementation of the project, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed. effectiveness of mscs is due to the following: * the ability of mscs to stimulate tissue regeneration * positive results of preclinical studies of the method of treatment of stress urinary incontinence (sui) in animals (female rats). after gynecological examination, diagnosis of sui, mscs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area. injected volume was 3 ml per patient. for injection mscs (6\*10\^6 cells) were mixed with collagen solution (3,5% w\|w). follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.

Eligibility criteria:
inclusion criteria: * stress urinary incontinence * absence of acute inflammatory manifestations in the genitourinary system exclusion criteria: * urethral or bladder malformations * acute and chronic infectious diseases: hiv, viral hepatitis, tuberculosis * mental disorders

Keywords: stress urinary incontinence mesenchymal stem cells
phase iii randomized study of ursodiol with vs without methotrexate for primary biliary cirrhosis

Conditions: Liver Cirrhosis, Biliary

Summary: objectives: i. compare the effects of ursodiol (ursodeoxycholic acid), with and without methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity in patients with primary biliary cirrhosis. ii. compare the effects of these regimens on the development of ascites, encephalopathy, varices (or bleeding from pre-existing varices), histologic liver changes, transplantation, and survival. iii. compare the toxicity and safety of each regimen.

protocol outline: this is a randomized, double-blind study. patients are stratified by participating institution and ludwig histologic stage. all patients are treated with ursodiol (ursodeoxycholic acid, udca) for 6 months. if entry criteria continue to be met, patients are randomly assigned to udca/methotrexate or udca/placebo. combination therapy continues for at least 5 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- the following criteria must be met prior to study entry and ursodiol treatment: bilirubin less than 3 mg/dl alkaline phosphatase at least 1.5 times normal limits albumin at least 3 g/dl the following criteria must be met prior to randomization to arms i and ii: primary biliary cirrhosis (pbc), i.e.: cholestatic liver disease for at least 6 months prior to randomization liver biopsy compatible with pbc within 6 months prior to randomization no biliary obstruction on ultrasound, computerized tomography, or cholangiography the following exclude: asymptomatic and stage i liver histology (ludwig classification) hepatic encephalopathy ascites variceal bleeding no liver disease of other etiology, e.g.: chronic hepatitis b or c autoimmune chronic active hepatitis alcoholic liver disease sclerosing cholangitis drug-induced liver disease symptomatic or obstructive gallstones --prior/concurrent therapy-- at least 6 months since the following immunosuppressives: cyclosporine tacrolimus methotrexate at least 3 months since other immunosuppressives, e.g.: azathioprine chlorambucil colchicine corticosteroids penicillamine at least 3 months since rifampin --patient characteristics-- life expectancy: no major illness limiting life span hematopoietic: wbc at least 2500/mm3 absolute granulocyte count at least 1500/mm3 platelet count at least 80,000/mm3 hepatic: see disease characteristics renal: creatinine clearance at least 60 ml/min pulmonary: no diffusion capacity or vital capacity less than 50% of predicted other: antimitochondrial antibody positive hiv antibody negative no alcoholism within the past 2 years no epilepsy requiring phenytoin no malignancy within the past 5 years other than skin cancer no pregnant women adequate contraception required of fertile patients

Keywords: cirrhosis gastrointestinal disorders primary biliary cirrhosis rare disease
telerehabilitation in rheumatic diseases

Conditions: Telerehabilitation

Summary: telerehabilitation (tr) became more popular during covid-19 pandemic due to social isolation and curfew. exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity.

telerehabilitation (tr) aims to decrease barriers such as distance, time and cost by using technology to patients and clinicians. it provides to obtain rehabilitation for patients who cannot go to a medical center due to physical, environmental or economic inadequacies. covid-19 is a contagious respiratory disease that is caused severe acute respiratory syndrome causing coronavirus-2 (sars-cov-2). it was firstly seen in december 2019 in wuhan, china and spread rapidly all over the world. world health organization (who) was declared covid-19 as a pandemic in march 2020. the most common symptoms are fever, cough and dyspnoea. social isolation and staying home have been suggested to reduce the spreading rate of covid-19 pandemic in many countries. in addition, curfew except necessity was applied in some countries and time of curfew varied by country. patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. in addition, old age and having concomitant chronic disease are among risk factors for coronavirus. therefore, national health services recommend patients to practice self-isolation and self-quarantine. however, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. physical inactivity and disuse are proven to cause joint destruction, decreased aerobic capacity and muscle atrophy in patients with rheumatic diseases.the importance and requirement for tr were observed better during the covid-19 pandemic. therefore, aim of this study was to investigate the effects of tr on fatigue, depression, anxiety, sleep quality, disease activity and quality of life.

Eligibility criteria:
inclusion criteria: * between the ages of 18 to 65 * have diagnosed with romatoid arthritis, ankylosing spondylitis, systemic lupus erthematosus or fibromyalgia exclusion criteria: * being pregnant * diagnosed with malignancy * had changes of medical treatment in the last 3 months * had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits * had regular exercise habit (minimally three days in a week) * had cardiac symphtoms according to new york heart association

Keywords: telerehabilitation rheumatic diseases covid-19