Kornimate/medical-research-clean huggingface dataset:
shared decision making in low risk prostate cancer

Conditions: Prostate Cancer

Summary: this study will evaluate the usefulness of an informational website designed to educate patients with prostate cancer about their options for treatment. the investigators hope that this website will assist patients with making informed decisions about their care and improving their satisfaction with the treatments they choose.

investigators will first ask patients to answer a series of questions to assess their wishes regarding treatment, knowledge about their disease and discussion with the physicians at initial patient visit. this initial survey should take approximately 20 minutes. once patients have selected a treatment path investigators will contact them again and ask them to fill out a short 10-minute survey online or by mail. investigators will contact patients by phone 2 weeks after their initial visit to see if they have made a decision. if not, investigators will contact patients by phone every 2 weeks or at an interval that works for the patient's schedule. finally, 3 months after the initial visit today investigators will contact patients for the last time and again ask you to fill out a short 10-minute survey online or by mail. once patients have completed the final survey there are no future surveys planned. investigators may contact patients by phone in the future to ask them to participate in another study.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma * internet access * able to read and understand english exclusion criteria: * evidence of nodal metastases * evidence of distant metastases * prior surgery, chemotherapy, pelvic radiation or prostate brachytherapy for prostate cancer

Keywords: low risk
assesment of jl1 expression in acute leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: the aim of this study is to assess jl1 expression by flow cytometric immunophenotyping in patients with b-cell acute lymphoblastic leukemia (all) and to correlate it with clinical, morphological, immunophenotypic, cytogenetic data and response to treatment.

acute lymphoblastic leukemia (all) is characterized by a rapidly progressive disease. it accounts for approximately 75% of all cases of childhood leukemias, that produces large and immature cells (20% or more lymphoblasts in the bone marrow (bm) and/or the blood) that can't carry out their normal bm function (terwilliger and abdul-hay, 2017). the main cause of all lies in the genetic or acquired injury to dna of a single cell in the bm with the presence of risk factors such as radiation, benzene exposure, down syndrome and past treatment with chemotherapeutic agents which leads to uncontrolled and exaggerated growth and accumulation of lymphoblasts which fail to function as normal blood cells. this results in blocking the production of normal blood cells and leads to anemia, thrombocytopenia and neutropenia. the most frequent signs are lymphadenopathies, hepatosplenomegaly, fever, anemia, signs of hemorrhage, and bone tenderness. the prognostic factors of all include patients' factors such as age, white blood cell (wbc) count and genetic factors such as chromosome and gene changes along with the immunophenotypic characteristics of the leukemic blast cells and the individual response to therapy. jl1 is a cd43 epitope and mucin family cell surface glycoprotein that is expressed on leukemic cells. it is expressed on hematopoietic cells at different stages of differentiation including early stage lymphoid precursors and late stage of myeloid cells. expression patterns of jl1 antigen occurs on cell surface of leukemic cells, bm cells and phytohemagglutinin (pha)-activated lymphocytes. most leukemic cells usually express jl1 even in weak positive cases. jl1 is usually expressed in about 60% of acute leukemia regardless of the lineage. it was also detected on cd34+ cd10+ lymphoid precursors and some immature myeloid cells in bm. an anti-jl1 (a monoclonal antibody that is selectively reactive with antigen in spite of the differences in the molecular weight) is mixed with a toxic substance that target the leukemic cells which leads to the emergence of its role as a therapeutic agent. therefore, the invistigators aim to study jl1 expression on leukemic cells in all patients in south egypt cancer institute, as we hypothesis that it can be used as an adjunctive marker for the initial diagnosis and the follow up of all.

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed b-cell all. 2. age group: both pediatric patients (\ 18 years old) will be included in our study. exclusion criteria: 1. patients with other types of hematologic neoplasms. 2 .relapsed patients.
comparison of the fixed combinations of brimonidine/timolol and dorzolamide/timolol in subjects with open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: this study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. in an investigator masked randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin analogue for a period of 12 weeks. after screening, patient returns at baseline, month 1, and month 3 for ophthalmic evaluations.


Eligibility criteria:
inclusion criteria: * male or female over 18 yrs. * female subjects of childbearing potential must have negative pregnancy test and provide contraception. * subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes. * subjects who are or have been insufficiently responsive to iop reducing monotherapy and use of either study medication is deemed appropriate. * subjects able to complete questionnaires and provide informed consent. exclusion criteria: * female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control. * subjects wherein the study drugs are containdicated. * subjects who have had introcular surgery with 6 months (3 months for laser). * subjects with known side effects/ allergy or sensitivity to any component of study treatments. * subjects with any uncontrolled systemic disease.
the effect of dietary intervention on symptoms, epigenetics, and gut microbiota in ibs

Conditions: IBS - Irritable Bowel Syndrome

Summary: the aim of the present study is to research whether subjects with irritable bowel syndrome (ibs) display epigenetic/genetic changes or altered microbiota compared to a non-ibs control group. further, we will investigate if these parameters as well as subjective ibs symptoms are affected by a 4-week long dietary intervention within the ibs patient group.

the study will be performed on 140 subjects with verified ibs. patients will be recruited from the clinic of gastroenterology or internal medicine as well as primary health care centers. at the start of the study patients will fill out protocols concerning rom iv criteria (to validate that ibs criteria are filled) as well as ibs symptom rating scales. they will be examined by a physician/researcher who will complete protocols of clinical data. blood and fecal samples will be collected. a control group of healthy, non-ibs individuals will go through the same procedure as described above. study participants with ibs will thereafter be randomized to receive an alternative diet resembling the fodmap (fermentable, oligo-, di-, mono-saccharides and polyols) diet (n=130), or to continue with their regular diet (control group; n=20). after 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. at this point in time, participants will also fill in ibs symptom rating scales again. samples from baseline and 4 weeks will be used for genetic/epigenetic (including genomic-wide association studies), gut microbiota and inflammatory parameter analyses. statistics to study differences in the above-mentioned parameters between patients and controls as well as before and after dietary intervention, mann-whitney u-test and wilcoxon test will be used, respectively.

Eligibility criteria:
inclusion criteria: * verified ibs according to rom iv criteria. exclusion criteria: * serious mental or somatic disease * abuse * inability to understand he swedish language * already on a diet (e.g. vegan, fodmap, gluten-free).

Keywords: ibs epigenetics dietary intervention gut microbiota inflammation genetics
effects of high-flow nasal cannula on exercise outcomes in lung transplant candidates: a pilot study

Conditions: Pulmonary Diseases; Oxygen Therapy; High-flow Nasal Cannula; Exercise Tolerance

Summary: the study evaluated patients on the national lung transplant waiting list. it was pioneering in assessing high-complexity patients with severe pulmonary diseases subjected to a cardiopulmonary rehabilitation protocol using a treadmill. the main findings indicate that the distance covered in the six-minute walk test was greater when using the high-flow nasal cannula supplementation. the improvement in exercise performance in this group is associated with a reduction in arterial carbon dioxide, optimization of hydrogen potential, and a decrease in dynamic hyperinflation, leading to fewer symptoms of dyspnea.

introduction: pulmonary diseases have a significant global prevalence, and lung transplantation is indicated for advanced cases. rehabilitation is essential for patients on the waiting list and requires ventilatory devices for symptom control during exertion. the high-flow nasal cannula is a promising alternative, but its effects on exercise outcomes are uncertain. objectives: to assess the effects of high-flow nasal cannula on the outcomes of the six-minute walk test. method: a randomized crossover clinical trial evaluated ten volunteers listed on the national lung transplant waiting list. three functional tests were performed: the six-minute walk test, incremental lower limb test with arterial blood gas analysis, and lower limb endurance test with inspiratory capacity measurement. each test was conducted on different days with different devices: high-flow nasal cannula and conventional oxygen therapy, totaling six test days. the inspired oxygen fraction was titrated to maintain normoxia between 90% to 96% and was kept constant for both interfaces.

Eligibility criteria:
inclusion criteria: * volunteers of both sexes * patients on the national lung transplant waiting list * chronic obstructive pulmonary disease * idiopathic or familial pulmonary fibrosis * bronchiectasis * sarcoidosis exclusion criteria: * osteoarticular limitation, * neuromuscular disease, * anemia * hyperglycemia * arrhythmia * left heart failure * pulmonary hypertension
randomized, double-masked, sham-controlled phase 4 study, efficacy, safety, and tolerability of intravitreal aflibercept monotherapy compared to aflibercept with adjunctive photodynamic therapy in patients with polypoidal choroidal vasculopathy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: the purpose of this study is to compare the efficacy and safety of intravitreal aflibercept monotherapy with the efficacy and safety of combined treatment with aflibercept plus standard photodynamic therapy (pdt) with verteporfin in age-related macular degeneration (amd) patients with polypoidal choroidal vasculopathy (pcv).

to compare the efficacy and safety of intravitreal aflibercept monotherapy with the efficacy and safety of combined treatment with aflibercept associated with standard photodynamic therapy (pdt) with verteporfin in age-related macular degeneration (amd) patients with polypoidal choroidal vasculopathy (pcv) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of pcv in caucasians.

Eligibility criteria:
inclusion criteria: * either gender and age ≥ 50. * naïve pcv patients. * confirmed diagnosis of symptomatic macular pcv in the study eye. * greatest linear dimension of the lesion of \< 5400 mm, assessed by icg angiography. * bcva at study entry of 25 to 80 letters (snellen equivalent 20/320 to 20/25). * lesion size in the study eye at study entry: * presence of pcv assessed by the central reading centre based on icg with active polyps with or without abnormal vascular network. * women must be using effective contraception, be post-menopausal for at least * months prior to trial entry, or surgically sterile. * ability to provide written informed consent. * ability to return for all study visits. exclusion criteria: * active inflammation or infection in the study eye. * uncontrolled intraocular pressure in the study eye. * ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epirretinal membrane with bcva impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema). * presence of centromacular scarring or atrophy indicating irreversible bcva loss. * prior treatment of the study eye with anti-vegf therapy or systemic use of anti-vegf products within 3 months prior to the study entry. * previous vitrectomy, macular laser treatment, pdt, or intraocular steroids in the study eye.
a dose ascending study to evaluate the safety of nh002 as a contrast agent in cardiac echocardiography

Conditions: Cardiac Disease

Summary: nh002 (perflutren lipid microspheres) injectable suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (lv) chamber and to improve the delineation of the lv endocardial border. the primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of nh002.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 20 years of age or older 2. ability to understand and the willingness to provide written informed consent 3. suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease 4. negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential exclusion criteria: 1. known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s) 2. chronic obstructive pulmonary disease 3. ejection fraction at screening or baseline \<40% 4. uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due to prolongation of the qt interval (qt corrected by fridericia's formula \>450 msec in males and \>470 msec in females) 5. clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase \>2 × upper limit of normal \[uln\]; serum creatinine \> 1.5 × uln) 6. known or suspected hypersensitivity to one or more of the ingredients of nh002, perflutren, or other echocardiographic contrast agent 7. received an investigational compound within 30 days before enrolling in the study 8. received any contrast agent either intravascularly or orally within 48 hours before nh002 administration 9. pregnant or lactating female (conception during the study should be avoided) 10. serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research 11. clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator 12. uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmhg or diastolic blood pressure ≥ 110 mmhg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmhg)

Keywords: echo echocardiogram cardiac ultrasound suboptimal contrast agent enhancing agent lvo lvebd
telemonitoring program in the vulnerable phase after hospitalization for heart failure

Conditions: Heart Failure; Acute Heart Failure

Summary: this pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated hf at 3 months post-discharge. and secondarily to evaluate its impact on clinical events, nt-probnp and efficacy and safety to facilitate the use and titration of the recommended drugs in patients with reduced ejection fraction at 90 days.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hospitalized for acute heart failure (regardless of the level of left ventricular ejection fraction) within 24 hours of discharge, or with a history of hospitalization for acute hf within 10 days prior to randomization. * own a smartphone (smartphone) with internet ability to speak and read spanish. * residence in the metropolitan area of buenos aires exclusion criteria: * pregnancy * alcohol or drug abuse * kidney failure in hemodialysis, * inability to use the app (ex: cognitive impairment, lack of social support, lack of ability to communicate) * active cancer * life expectancy less than 1 year * candidates for care home or institutional end of life * severe psychiatric illness * planned cardiac surgery * patient unable or unwilling to give informed consent to participate.

Keywords: telemonitoring heart failure vulnerable phase
analysis of iliac crest biopsies from patients receiving risedronate

Conditions: Osteoporosis

Summary: this study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. the objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.


Eligibility criteria:
inclusion criteria: * completed month 36 of study rvn-008993. * underwent an iliac crest bone biopsy at month 36. exclusion criteria: * was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study rvn-008993.
complex treatment of a chronic anal fissure

Conditions: Fissure in Ano

Summary: this study is aimed at studying the efficacy and safety of treating chronic anal fissure with botulinum toxin versus lateral subcutaneous sphincterotomy.

chronic anal fissure is a rupture of anal canal mucosa lasting for more than 2 months and resistant to non-surgical treatment. this condition is attended by severe pain syndrome during and after bowel movement (defecation). this condition is most frequent in younger and working-age adults; therefore, the treatment issue is of particular relevance. the main cause of chronic anal fissure development is spasm of the internal sphincter. it should be eliminated in the first instance, in order to provide the effective therapy. all the main treatment methods, such as medicinal relaxation of the internal sphincter with 0.4% nitroglycerin ointment, lateral subcutaneous sphincterotomy, and pneumodivulsion of the anal sphincter are aimed at its removal. however, the optimal method has not yet been developed. non-surgical treatments are often attended by relapse of disease, while surgical treatment is often complicated by intestinal contents incontinence, usually gas and loose or hard stool in some occasions (grade 3 anal sphincter insufficiency). in particular, lateral subcutaneous sphincterotomy performed in such patients is associated with an increase in the degree of anal incontinence in the early post-operative period. botulinum toxin type a application in complex treatment of patients with chronic anal fissure (after fissure excision) is intended to improve the therapy results, namely to reduce the frequency and duration of anal sphincter insufficiency after sphincter spasm removal (reduction in the number of patients suffering from post-operative incontinence).

Eligibility criteria:
inclusion criteria: * patients with chronic anal fissure exclusion criteria: * inflammatory diseases of the colon * pectenosis * previous surgical interventions on the anal canal * iv grade internal and external hemorrhoids * rectal fistula * severe somatic diseases at the decompensation stage * pregnancy and lactation * individual intolerance and hypersensitivity to botulinum toxin * myasthenia gravis and myasthenia-like syndromes * anal sphincter insufficiency

Keywords: internal sphincterotomy anal fissure chronic anal fissure botulinum toxin a proctologic diseases surgical treatment chronic anal pain fecal incontinence spasm of the internal sphincter anal sphincter insufficiency randomized
efficacy and safety of eslicarbazepine acetate as therapy for patients with painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: the primary objective of the study is to assess the efficacy of eslicarbazepine acetate (esl) as therapy for patients with painful diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * written informed consent to participate in the study * men and women aged 18 years or older * diagnosis of diabetes mellitus type 1 or 2 * diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment * stable glycemic control: (total glycated haemoglobin \[hba1c\] level ≤ 11% at screening) * cooperation and willingness to complete all aspects of the study * completion of at least 4 daily diaries during the week preceding randomisation * a minimum average daily pain score of 4 on the numeric rating pain scale (nrps) in the last 4 diary entries before randomisation. exclusion criteria: * pain of other origin that might confound the assessment of neuropathic pain of diabetic origin * significant or unstable medical or psychiatric disorders * drug or alcohol abuse in the preceding 2 years * peripheral vascular disease with a history of amputation, except amputation of toes * severe renal function impairment, as shown by calculated creatinine clearance values \< 30 ml/min at screening * relevant clinical laboratory abnormalities (e.g., na+ \ 2.0 times the upper limit of normal, white blood cell count (wbc) \<2,500 cells/mm3) * previous participation in any study with eslicarbazepine acetate * pregnancy or breast feeding * history of hypersensitivity to the investigational products or to drugs with a similar chemical structure * history of non-compliance * likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol. * participation in a clinical study within 3 months prior to screening * any clinically significant concomitant condition, which might influence the assessments or conduct of the trial

Keywords: pain diabetes neuropathy