Kornimate/medical-research-clean huggingface dataset:
high intensity focused ultrasound treatment of breast tumors. brifu study

Conditions: Breast Cancer Female

Summary: monocentric prospective study evaluating the efficacy of high intensity focused ultrasound (hifu) in breast tumors.

incidence of breast cancer increases with the lifetime of the population, and represents an important socio-economic issue. diagnosis and treatment are major public health issues. high instensity focused ultrasound (hifu) is a minimally invasive technique which decreases the risk of post-treatment complications and allows shorter hospitalization times. this technology is also remarkable for the absence of limitation related to the dose delivered, which makes it possible to repeat if necessary and the absence of ionizing radiation both for the treatment itself and for its guidance (mri). the main objective is to evaluate the efficacy of hifu for the treatment of breast tumors, based on histological criteria. indication : histologically invasive ductal carcinoma, t0, with unifocal or plurifocal lesion, with or without associated microcalcifications, measuring 15 mm maximum on ultrasound and clinical n0. course of the study : * signature of consent, * clinical and radiological assessment at baseline, * realization of the hifu procedure under local anesthesia and sedation (j0), * total or partial mastectomy depending on the lesion (between d2 and d8), * consultation with surgeon (j30), number of patients : 15 patients will be included in this pilot study. if no success is observed, the study will be stopped and the technique considered inefficient. if there are one or more successes, an independant data monitoring committee (idmc) will meet to propose an additional trial if necessary with the data from this trial.

Eligibility criteria:
inclusion criteria : 1. histologically proven infiltrating ductal carcinoma with the analysis of hormone receptors, tumor grade, her-2 expression. 2. t0 lesion, unifocal or plurifocal, with or without micro-calcifications associated, measuring 15 mm maximum major axis on ultrasound. 3. clinical n0. 4. bra cup size greater than or equal to b. 5. markable and identifiable lesion in mri. 6. indication of partial or total mastectomy in case of multifocal lesions or extensive calcification associated with axillary surgery. 7. breast assessment performed by a referent radiologist: mammography, ultrasound, clinical examination. 8. no contraindication to mri. exclusion criteria : 1. infiltrating lobular carcinoma and pure ductal carcinoma in situ. 2. bilateral lesion. 3. non-detectable mri lesions, within 10 mm of the skin, greater than 15 mm on ultrasound. 4. unifocal palpable tumor. 5. cup size bra equal to a. 6. cutaneous lesion on the breast to be treated by hifu. 7. impossibility of ventral decubitus immobility, extended arm, during 1 hour. 8. pregnant or postpartum patient. 9. patient participating in another interventional clinical trial within 30 days of enrollment and during the trial.

Keywords: high intensity focused ultrasound
predictors of attempted inferior vena cava filters retrieval.

Conditions: Venous Thromboembolic Disease

Summary: the inferiorvena cava (ivc) with filters has been recommended when there is a contraindication or a failure of anticoagulation. due to the side effects related to the filters, it is recommended to remove them as soon as possible. it's a retrospective study in a french hospital to evaluate the retrieval rate and predictors of filter removal. all the data of consecutive patients who had a retrievable inferiorvena cava filter (ivcf) inserted in the investigator center between april 2012 and november 2019 are included.


Eligibility criteria:
inclusion criteria: * patients who had a cave filter placement at saint-etienne hospital between april 2012 and november 2019. exclusion criteria: * none

Keywords: inferior vena cava filter inferior vena cava filter retrieval inferior vena cava filter complications deep vein thrombosis (dvt) pulmonary embolism venous thromboembolism event (vte)
distribution of nutrient derived amino acids

Conditions: Muscle Mass; Protein Intake; Diet Modification; Protein Synthesis; Protein Breakdown; Sarcopenia

Summary: the project examines over several days how the distribution pattern of dietary protein stimulate and affect the protein turnover of important proteins in the aging perspective, such as skeletal muscle proteins.


Eligibility criteria:
inclusion criteria: * men and women * between 65-80 years of age exclusion criteria: * bmi above 30 * smokers * vegetarians * diabetes or other metabolic diseases * medical treatment which affects protein turnover * gastro-intestinal diseases, reduced kidney or liver function, or chronic inflammation diseases * elevated blood-pressure or signs of atherosclerosis * more than 5 hours of regular exercise each week

Keywords: dietary protein sarcopenia protein turnover muscle protein
fluvastatin in adults with dislipidemia with history of muscle problems

Conditions: Dyslipidemia

Summary: the purpose of the study is to find a good therapy for patients who need to be treated for high cholesterol and who have difficulty tolerating other statins (such as pravastatin, simvastatin, lovastatin, atorvastatin, rosuvastatin) due to muscle pain.


Eligibility criteria:
inclusion criteria: * dyslipidemia * history of myalgia exclusion criteria: * previous treatment with fluvastatin * age \< 18 years other protocol-defined inclusion and exclusion criteria may apply.

Keywords: dyslipidemia, adults, fluvastatin
a study of macitentan in japanese pediatric participants with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at week 24 in pediatric populations.


Eligibility criteria:
inclusion criteria: * pulmonary arterial hypertension (pah) belonging to the nice 2013 updated classification group 1 * pah diagnosis confirmed by historical right heart catheterization where in the absence of pulmonary vein obstruction and/or significant lung disease pulmonary artery wedge pressure (pawp) can be replaced by left atrium pressure (lap) or left ventricular end diastolic pressure (lvedp) (in absence of mitral stenosis) assessed by heart catheterization * world health organization (who) functional class (fc) i to iv * pah-specific treatment-naïve participants or participants on pah-specific treatment * a female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hcg) test at screening and a negative urine pregnancy test at the first administration of study intervention * a female participant must not get pregnant and must agree not to donate eggs during the study and for a period of up to 4 weeks following the end of study exclusion criteria: * participants with pah due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease, and/or pulmonary capillary hemangiomatosis, and persistent pulmonary hypertension of the newborn * participants with the following diseases: pulmonary vein stenosis; bronchopulmonary dysplasia * severe hepatic impairment, example, child-pugh class c, at screening * pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 4 weeks after the last dose of study intervention * known allergies, hypersensitivity, or intolerance to macitentan or its excipients * participant with pah associated with open shunts, with congenital cardiac abnormalities such as univentricular heart, with pulmonary hypertension due to lung disease, and renal dysfunction
assessment of measurement variability across automated biometry devices

Conditions: Myopia

Summary: this is a non-interventional prospective, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the orbscan ii compared to the iol master 700 (zeiss), iol master 500 (zeiss), atlas 9000 (zeiss), lenstar 900 (haag-streit), argos (alcon), itrace (tracey), pentacam (oculus), and manual calipers.

this is a non-interventional prospective, single center, bilateral, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the orbscan ii compared to the iol master 700 (zeiss), iol master 500 (zeiss), atlas 9000 (zeiss), lenstar 900 (haag-streit), argos (alcon), itrace (tracey), pentacam (oculus), and manual calipers. additional biometric devices or external photography may be included as well.

Eligibility criteria:
inclusion criteria: 1. adults ages 18-50 years of age with healthy eyes and no prior ocular surgery 2. at least -1.00 of myopia (spherical equivalent) 3. able to comprehend and willing to sign informed consent and consent and complete all required testing procedures 4. clear intraocular media exclusion criteria: 1. any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study 2. history of or current retinal conditions or predisposition to retinal conditions 3. amblyopia or strabismus in either eye 4. history of or current anterior or posterior segment inflammation of any etiology 5. any form of neovascularization on or within the eye 6. glaucoma (uncontrolled or controlled with medication) 7. optic nerve atrophy 8. subjects with diagnosed degenerative eye disorders 9. subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. connective tissue disease, immunocompromised, clinically significant atopic disease, etc.)

Keywords: -1.00 diopter spherical equivalent
ovarian hyperstimulation and fibrin clot properties.

Conditions: Fibrin Blood Clot; Infertility, Female; Endometriosis

Summary: the impact evaluation of ovarian hyperstimulation on coagulation and fibrinolysis in infertile women. comparative analysis between different ovarian stimulation protocols on thrombin formation and efficiency of fibrinolysis in women diagnosed with infertility.

infertility is a common problem. assisted reproductive techniques (art) increases the chance of getting pregnant by couples undergoing such treatment. unfortunately, the numer of live births after art remains still low. over the past three decades, physicians have tried to improve infertility diagnosis and increase its successful treatment. an effort aimed at increasing effectivenes of diagnosis resulted in hypothesis that one of probable reasons of infertility may be the occurrence of microclots, which worsen implantation and embryos development. there are currently no published studies describing the effects of different ovarian hyperstimulation protocols on hemostasis (coagulation and fibrinolysis). the parameters of thrombin generation and efficiency of fibrinolysis will be evaluated in women qualified for ovarian hyperstimulation. the study may improve the effectiveness of art.

Eligibility criteria:
inclusion criteria: * infertility defined based on the who 2010 criteria exclusion criteria: * ovarian involvement * oral contraceptives use within previous 3 months * dienogest therapy within 3 months until art * thrombotic events in the medical history * severe hypertension * diabetes mellitus * the presence of known vte risk factors, including obesity, recent major surgery with prolonged immobilization or trauma, * deficiency of antithrombin, protein c or protein s, * antiphospholipid syndrome, * known malignancy, * any chronic inflammatory diseases (e.g. rheumatoid arthritis) * advanced chronic renal disease (estimated glomerular filtration rate \[egfr\] \<30 ml/min), * international normalized ratio (inr) more than 1.2 at the day of blood draw * pregnancy.

Keywords: coagulation fibrinolysis ovarian hyperstimulation infertility
biomarkers for ventilator-associated pneumonia

Conditions: Pneumonia, Ventilator-Associated

Summary: the purpose of this study is to evaluate different peptide biomarkers, variations in the microbiome and patterns in the bacterial transcriptome as prognostic or diagnostic biomarkers of vap.


Eligibility criteria:
inclusion criteria: * admission to an intensive care unit * intubation within last 24 hours * anticipated mechanical ventilation of at least 48 hours exclusion criteria: * fio2 above 70% or peep above 15 * severe coagulopathy (spontaneous pk(inr) \>1.8 or thrombocytes \<50). prophylaxis treatment dose of lmwh or factor xa inhibitors/noac is not an exclusion criteria. if higher doses of these substances are administered, the responsible clinician should be consulted before sample collection. * ongoing infection of the lungs at admission to the icu. * severely elevated or instable intracranial pressure.

Keywords: vap
population-based study in screening for liver fibrosis

Conditions: Liver Diseases

Summary: study to assess the prevalence of significant liver fibrosis in general population using transient elastography

this is a population-based study. subjects will attend a primary care center where a physical examination, general blood test and transient elastography will be carried out. only the group of patients with high-risk for liver fibrosis will be evaluated in a second visit at the university hospital.

Eligibility criteria:
inclusion criteria: * age ≥ 40 years * able to give informed consent exclusion criteria: * previously known chronic liver disease (including cholestasis). patients with already known liver steatosis but no diagnosis of liver fibrosis or cirrhosis can be included * subjects with mental incapacity, language barrier, insufficient social support or any other reason considered by the investigator precluding adequate understanding or cooperation in the study * subjects with a history of current malignancy including solid tumors and hematologic disorders * subjects with significant extrahepatic disease that may impair short-term prognosis (including congestive heart failure new york heart association grade iv, copd gold \>3) * subjects with kidney disease (serum creatinine \>3mg/dl or under renal replacement therapy)
gts21-201 for alzheimer disease:gts-21 administered daily for 28 days to participants with probable alzheimer's disease

Conditions: Alzheimer Disease

Summary: a double blind, placebo-controlled randomized study to compare the safety and tolerability of gts-21 (25 mg tid, 50 mg tid, 75 mg tid and 150 mg tid) when administered daily for 28 days to participants with probable alzheimer's disease

a double blind, placebo-controlled randomized study to compare the safety and tolerability of gts-21 (25 mg tid, 50 mg tid, 75 mg tid and 150 mg tid) when administered daily for 28 days to participants with probable alzheimer's disease

Eligibility criteria:
inclusion criteria: * probable alzheimer exclusion criteria: * others

Keywords: alzheimer probable alzheimer disease
cough frequency in chronic obstructive pulmonary disease

Conditions: COPD Exacerbation

Summary: acute exacerbations of copd remain a common cause of morbidity and are associated with a sustained increase in the normal respiratory symptoms of dyspnoea, cough, and sputum volume and purulence. it has previously been shown that a change in cough symptoms occurs in 51.7% of exacerbations in copd. we wish to record cough during a copd exacerbation to determine whether this can be a objective marker of exacerbation duration and severity.

acute exacerbations of copd remain a common cause of morbidity and are associated with a sustained increase in the respiratory symptoms of dyspnoea, cough, sputum volume and sputum purulence. cough is one of the most commonly reported and key symptoms in copd patients. cough can also be a useful factor in finding patients at risk of progressive airflow obstruction and cough along with the breathlessness is the major cause of distress in patients with chronic obstructive airways disease (copd). there is limited literature looking into cough and copd especially objective assessments. in clinical practice and in most clinical trials scoring systems ie quality of life questionnaires or visual analogue scores, have been used to measure copd exacerbation severity, although these may give an indication of the perceived severity of the symptom, they are inherently subjective and may be influenced by other factors. shortfalls have prompted the development of cough recorders as an objective measure of this symptom. with this in mind we propose recruit 30 subjects with non-infective exacerbations of copd and monitor their cough frequency as an inpatient in acute exacerbation and for 45 days post hospital discharge in order to elucidate the natural history of cough during and after an exacerbation.

Eligibility criteria:
inclusion criteria: * male/females aged between 40-80 years. * previous diagnosis of copd. * acute exacerbation of copd requiring treatment with antibiotics and/or corticosteroids. * symptoms of increased breathlessness, cough, sputum volume or sputum purulence. * acute exacerbation of copd hospitalised within 48 hrs of study participation. * on a stable therapeutic regimen for copd for 8 weeks prior to inclusion. * known history of cigarette smoking at least 10 pack yrs. * willing and able to comply with study procedures. * able to provide written informed consent to participate. exclusion criteria: * acute exacerbation of copd within 8 weeks prior to inclusion. * clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus. * on long-term oxygen therapy.

Keywords: exacerbation copd cough
phase 1 study evaluating zen003365 in relapsed/refractory lymphoproliferative malignancies or relapsed/refractory aml

Conditions: Lymphoproliferative Malignancies; Acute Myeloid Leukemia

Summary: the purpose of this study is to determine safety, tolerability, dose limiting toxicities (dlt) and maximum tolerated dose (mtd) of zen003365 in patients with relapsed/refractory lymphoproliferative malignancies (lpm) or relapsed/refractory acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: dose escalation and expansion stages: * ecog performance status ≤ 1 for lpm patients, ≤ 2 for aml patients * age 18 years or older * adverse events (aes), except for alopecia, from any previous treatments must have recovered to eligibility levels from prior toxicity * adequate renal, hepatic and coagulation function, as specified per protocol * written informed consent granted prior to any study-specific screening procedures lpm patients: * histologically confirmed lymphoproliferative malignancy * have received prior protocol-specified disease-dependent prior treatments * have measurable disease * platelets ≥ 75,000/µl (≥50,000/µl if bone marrow involvement), absolute neutrophil count (anc) ≥ 1,000/ µl, and hemoglobin (hgb) ≥ 8 g/dl * patients must have been off previous anticancer therapy for at least 3 weeks or 5 half-lives, whichever is longer, and the subject must have recovered to eligibility levels from prior toxicity aml: * refractory or relapsed aml patients, without curative intent, e.g., not a stem cell transplant candidate * any prior chemotherapy must have been completed ≥ 2 weeks, any therapy with biologics must have been completed ≥ 4 weeks prior to day 1 of study treatment, and the participant must have recovered to eligibility levels from prior toxicity * blast count ≤ 10,000/µl prior to initiation of therapy exclusion criteria dose escalation and expansion stages: * prior exposure to a bet inhibitor * prior allogeneic hematopoietic cell transplant * chronic graft versus host disease * known, active fungal, bacterial, and/or viral infection * uncontrolled autoimmune hemolytic anemia or thrombocytopenia * current subdural hematoma * cns or leptomeningeal metastases * requirement for medications or agents known to be sensitive cyp3a4 substrate drugs, cyp3a4 substrate drugs with a narrow therapeutic range or to be strong inhibitors/inducers of cyp3a4 * requirement for immunosuppressive agents * evidence of significant cardiovascular disease or significant screening ecg abnormalities * any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. aml patients: * acute promyelocytic leukemia (apl) * chronic myeloid leukemia (cml) in blast crisis

Keywords: chronic lymphocytic leukemia b-prolymphocytic leukemia non-hodgkin's lymphoma follicular lymphoma mantle cell lymphoma marginal zone lymphoma small lymphocytic lymphoma diffuse large b-cell lymphoma unclassifiable lymphoma t-cell lymphoma richter's syndrome waldenström's macroglobulinemia
effects of platelet-rich fibrin and vitamin dꝫ injections on root resorption

Conditions: Root Resorption

Summary: this study aims to investigate and compare the effect of prf and vitamin dꝫ injections on root resorption by using cbct

* participants will be recruited from the faculty of dentistry, beni-suef university. all subjects will be informed of the treatment procedures and will sign a consent form. * subjects will be randomly divided into two groups: group 1 (prf group): upper canine retraction will be facilitated by prf injection that will be randomly assigned to one side (experimental side). the contralateral side will serve as the control one. group ii (vitamin dꝫ group): canine retraction will be facilitated by vitamin dꝫ injection that will be randomly assigned to one side (experimental side). the contralateral side will serve as the control one. * the predicted sample size (n) was a total of (28) cases (i.e. 14 cases per group). sample size calculation was performed using g\*power version 3.1.9.7 * randomization: simple randomization will be designed with the aid of a computer-generated schedule with 1:1 allocation ratio. allocation concealment will be achieved using identical opaque, sealed envelopes. randomization and allocation concealment will be performed by one of the academic staff who will not be involved in the study and will keep the allocation table away from the operators. the operator will shuffle the sealed envelopes and will ask the patient to pick one envelope at the time of recruitment. in each group, a randomly selected side will act as the experimental side while the contralateral side will serve as the control. blinding of the operators will not be applicable and so blinding will be limited to the outcome assessment. - methodology: all patients will be treated with a 0.022-inch mbt bracket system. leveling and alignment phase will be completed until a 0.017 x 0.025'' stainless steel wire will be inserted passively into the bracket slot. before canine retraction, the subject will be randomly assigned to one of the groups (prf or vitamin dꝫ group). in both groups, canine retraction will be performed with closed ni-ti coil springs with a force of 150 g per side that will be adjusted by the use of a force gauge.

Eligibility criteria:
iinclusion criteria: 1. age: 18- 40 years old. 2. angle class i or class ii dental malocclusion that required bilateral maxillary first premolar extraction and upper canine retraction as a part of the treatment plan. 3. good to fair oral hygiene. 4. normal probing depth. exclusion criteria: 1. active periodontal disease. 2. poor oral hygiene. 3. systemic diseases or medications that alter bone metabolism or tooth movement. 4. craniofacial anomalies

Keywords: platelet-rich fibrin vitamin d3 root resorption