Kornimate/medical-research-clean huggingface dataset:
modified post-transplant cyclophosphamide regimen for children with juvenile myelomonocytic leukemia

Conditions: Hematopoietic System--Cancer

Summary: hematopoietic stem cell transplantation (hsct) is the only curative option for most of juvenile myelomonocytic leukemia (jmml). however, relapse after hsct severely influence the long-term overall survival (os). researches demonstrate that these malignant myeloid disorders is a particular responsiveness to epigenetic therapy with the dna-hypomethylating agents decitabine. however, hypomethylating therapy does not eradicate the malignant clone in jmml and an emerging concept with intriguing potential is the combination of hypomethylating therapy and hsct. graft-versus-host disease (gvhd) is major complication after hsct as a threshold of the quality of patient life. many data indicate that post -transplant cyclophosphamide (pt/cy) is an effective method to control the occurrence of gvhd.

hematopoietic stem cell transplantation (hsct) is the only curative option for most of juvenile myelomonocytic leukemia (jmml). however, persistent disease statute and relapse after hsct severely influence the long-term overall survival (os). researches demonstrate that jmml is an aggressive myeloproliferative neoplasm occurring in young children. the common denominator of these malignant myeloid disorders is a particular responsiveness to epigenetic therapy with the dna-hypomethylating agents 5-azacytidine (azacitidine) or decitabine. however, hypomethylating therapy does not eradicate the malignant clone in jmml and an emerging concept with intriguing potential is the combination of hypomethylating therapy and hsct. graft-versus-host disease (gvhd) is severe complication after hsct. post -transplant cyclophosphamide (pt/cy) is an effective method to control the occurrence of gvhd. based on these encouraging results, investigators launched a noval method for patients diagnosed as jmml and treated in our institution. they modified pt/cy conditioning regimens. patients all subsequently received modified dcag regimen as the induction chemotherapy including decitabine of 20 mg/m2 intravenously over 4 h for five consecutive days (day -15 to -11) followed by cytarabine of 10 mg/m2 q12 h for 7 days (day -15 to -9), aclarubicin of 10 mg/day for 4 days (day -12 to -9), and g-csf 5µg/kg per day for priming until white blood count was \>20 x109/l and immediately followed by myeloablative conditioning regimen (mac) consisted with thymoglobulin (2.5mg/kg/day) which was administered for 3 days （day -8 to -6), iv bu (4 mg/kg in divided doses daily for 4 days) on days -5, -4, -3, and -2, iv flu (30 mg/m2 once daily for 4 days, total dose 120 mg/m2) on days -5, -4, -3, and -2 and iv melphlan (70 mg/m2 once daily for 3 days, total dose210 mg/m2) was performed on days -4 and -2.

Eligibility criteria:
inclusion criteria: * jmml patients diagnosed in our center and with the indications of transplant without the suitable donor. exclusion criteria: * jmml patients do not need to transplant.

Keywords: hsct pt/cy decitabine jmml
influence of multidisciplinary breast tumor board on physician decision

Conditions: Breast Cancer; Breast Neoplasms; Surgery; Oncology

Summary: in our study, the treatment plan for the case prior to the breast tumor counseling will be asked to physician and the treatment protocol observed by the primary physician will be observed after the decision of the tumor council.


Eligibility criteria:
inclusion criteria: patients having primary breast cancer exclusion criteria: patients having recurrent breast cancer -
swog-9208 quality of life and health status in patients with stage i or stage ii hodgkin's disease

Conditions: Lymphoma; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment on patients with cancer. purpose: this clinical trial studies the impact of therapy on the health status and quality of life of patients with stage i or stage ii hodgkin's disease who are receiving radiation therapy with or without chemotherapy.

objectives: i. evaluate prospectively the health status and quality of life of patients with stage i/iia hodgkin's disease randomized on protocol swog-9133 (clb-9391) to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine. ii. describe the short-term effects of these treatments on these patients and compare their impact on quality of life (i.e., patient symptom status, health status, fatigue). iii. evaluate the intermediate and long-term effects of these treatments on these patients and compare their impact on quality-of-life outcomes over 5 years. outline: quality-of-life assessment. cancer rehabilitation evaluation system short form, cares-sf; symptom and personal information questionnaire (including symptom distress scale, mos sf-36 fatigue scale, mos sf-36 health perception rating, demographics); cover sheet. projected accrual: approximately 500 patients will be accrued over 7 years.

Eligibility criteria:
disease characteristics: patients must be eligible for and registered to swog-9133 patient characteristics: patients must be able to complete the questionnaires in english. if they are not able to complete questionnaires in english, patients may be registered to swog-9133 without participating in swog-9208. the symptom and personal information questionnaire #1, the cancer rehabilitation evaluation system short form (cares-sf) and cover sheet must be completed prior to registration and randomization on swog-9133.

Keywords: stage i adult hodgkin lymphoma stage ii adult hodgkin lymphoma psychosocial effects of cancer and its treatment
phase i deep brain stimulation (dbs) vs. best medical therapy (bmt) trial

Conditions: Parkinson's Disease

Summary: the goals of this study are to determine if simultaneous bilateral subthalamic nucleus stimulation or simultaneous bilateral globus pallidus stimulation is more effective in reducing symptoms of parkinson's disease, and if deep brain stimulation or best medical therapy is more effective in improving parkinson's disease symptoms

deep brain stimulation (dbs) is a promising therapy for parkinson's disease (pd). whether dbs is superior to comprehensive best medical therapy or whether some patients or symptoms respond better to dbs in one area of the brain or the other is currently not known. the goals of this project are to compare the effectiveness of dbs and comprehensive medical therapy as treatments for pd, and to compare bilateral dbs at 2 areas of the brain--the subthalamic nucleus (stn) and the globus pallidus (gpi)--to determine the most effective brain site for surgical intervention in this prospective, randomized, multi-center trial, 316 patients will be enrolled at 13 centers over four and a half years. patients will initially be randomized to immediate surgery (dbs) or to 6 months of "best medical therapy." bmt patients will then proceed into the surgical phase of the trial. the dbs site (stn or gpi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial. patients will be followed for two years post surgery (24-30 months). effective 08/05/05, randomization to the bmt arm has been discontinued since the study has sufficient information to compare the outcomes of dbs and bmt patients at 6 months. the findings will be critically important in establishing the optimal surgical treatment of the disabling symptoms of pd.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease, * hoehn and yahr stage 2 or worse "off" medications, * l-dopa responsive but with persistent disabling symptoms (i.e., refractory to "best medical treatment" with motor fluctuations, dyskinesias), * on stable medical therapy for at least one month prior to enrollment, * age \> 21, * available and willing to be followed-up according to study protocol, and * no intracranial abnormalities that would contraindicate surgery (based on pre-operative magnetic resonance imaging of the brain). exclusion criteria: * "parkinson's plus" syndromes, * medical contraindications to surgery or stimulation, * active alcohol or drug abuse, * score on minimental status exam 24 or lower, or other neuropsychological dysfunction (e.g., dementia) that would contraindicate surgery, * concurrent participation in another research protocol.

Keywords: parkinson's disease levo-dopa tremor dyskinesia subthalamic nucleus globus pallidus
ketamine in refractory convulsive status epilepticus

Conditions: Status Epilepticus

Summary: to evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.


Eligibility criteria:
inclusion criteria: * diagnosis and clinical eegrafica of refractory convulsive status epilepticus * refractoriness of the drug i and ii line * written informed consent from parents or legal guardian. * administration of rating scales in the risk of mortality (pim iii) and severity of se (stess, status epilepticusseverity score) to be performed prior to randomization. exclusion criteria: * contraindications to the use of the medication/s in the study. * pregnant or suspected pregnant.

Keywords: refractory convulsive status epilepticus ketamine conventional anesthetics children
vascular photobiomodulation on sleep qualityand stress

Conditions: Stress Disorder; Sleep Disorder

Summary: randomized clinical trial to evaluate the effect of vascular photobiomodulation on sleep quality, relaxation and stress when compared to placebo.

the quality of sleep is directly linked to the quality of human life. irradiation of blood in the transcutaneous vascular technique is believed to decrease blood viscosity and platelet aggregation; activates superoxide dismutase; promotes increased oxygen content and stimulates microcirculation, it also stimulates increased serotonin production and cortisol reduction. serotonin functions include sleep initiation, mood improvement, anxiety and depression. therefore, the objective of the present project is to evaluate the effect of ilib on salivary biomarkers related to stress and sleep. therefore, participants with problems related to sleep quality will be selected and divided into 2 groups, group 1 undergoing ilib therapy twice a week for 30 minutes and group 2 the same frequency and time of application, but with placebo equipment. at the end of 10 sessions, salivary biomarkers related to stress and sleep and the patients' perception will be evaluated through specific questionnaires on the effect of ilib on sleep, stress and relaxation.

Eligibility criteria:
inclusion criteria: * poor sleep quality. * participants who for at least six months have had poor sleep quality (score \> 5 points), measured using the psqi, exclusion criteria: * use medications or perform treatments that may affect the sleep cycle * treatment for hypertension * asthma, * attention deficit disorder, * diabetes.

Keywords: stress sleep disorder photobiomodulation laser therapy
psychometric validation (quality-of-life scale) in young women with a non metastatic breast cancer and her partner

Conditions: Breast Cancer

Summary: * selection of patient and preparation of questionnaires * presentation of the study by the doctor * verbal consent of participants (patient and partner) * delivery of booklets * response to documents (questionnaires and written consent) at home, send by mail

1. before consultation : selection of patients according to inclusion criteria by persons in charge and preparation of inclusion file 2. during the consultation : * presentation of the study by the investigator * the investigator signs the information note and give two file to the patient (1 for her and 1 for her partner : both contains 1 information note signed by the investigator, 1 questionnaire and 2 stamped envelopes * finally, the investigator fill-in the medical form and send the original to the university (université de lille 3) 3. at home : * signature of the information note and the participation consent form * patients and partner responds to their questionnaire (including socio-demographique questionnaire) * they send the documents thanks to stamped envelopes: 1. they send information note to the medical center 2. they send the questionnaires to the university

Eligibility criteria:
inclusion criteria: * \>18 years old (patient and partner) * \<45 years old (patient) * patient with a non metastatic breast cancer * patient treated or previously treated by chemotherapy * patient and her partner live together for at least 6 months when they complete the questionnaires. exclusion criteria: * patient or patner with psychiatric trouble * native language other than french

Keywords: breast cancer quality of life women partner
a study of olumacostat glasaretil gel in subjects with acne vulgaris

Conditions: Acne Vulgaris

Summary: the objectives of this study are to assess the safety and efficacy of olumacostat glasaretil gel compared to vehicle in patients with acne vulgaris


Eligibility criteria:
inclusion criteria: * signed informed consent and, for subjects under legal adult age, signed assent * age ≥ 9 years * clinical diagnosis of facial acne vulgaris defined as: * at least 20 inflammatory lesions, and * at least 20 non-inflammatory lesions, and * investigator global assessment of 3 or greater exclusion criteria: * active cystic acne or acne conglobata, acne fulminans, and secondary acne * two or more active nodulocystic lesions on the face * clinically significant abnormal laboratory or ecg result * subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the baseline visit * treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to baseline * treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to baseline * treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills). * use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to baseline. * oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin a supplements greater than 10,000 units/day within 6 months prior to baseline * facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks
effects of fibres combined with probiotics on uric acid in an ex vivo fermentation model

Conditions: Hyperuricemia

Summary: in this study, we will collect faecal samples from individuals with hyperuricaemia (assessed by blood test) and perform in vitro faecal fermentation studies to assess how probiotics in combination with fibres affect urate metabolism in these faecal samples.

in this study, the investigators will collect blood samples to check if recruited participants have hyperuricemia, and if yes, stool samples will be collected for laboratory faecal fermentation tests. the research project aims to investigate the effects of probiotics and dietary fibers on stool samples, to understand if and how they can support the gut microbiota to break down uric acid in the gut. participation in the study involves data collection and sampling on three occasions. during the first visit, participants will provide a blood sample, and if they have increased urate levels, they will be asked to complete questionnaires and be provided with materials for stool sampling during the second visit. during the third visit, they will provide the stool sample, which will then be used in the faecal fermentation experiments, where different fibres (beta-glucans) will be tested in combination with probiotics.

Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to any study-related procedures 2. age 18-80 years old 3. bmi range 18.5-35 kg/m2 4. blood uric acid above 0.36 mmol/l (6 mg/dl) 5. willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages), until collection of faecal material 6. willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study, until collection of faecal material exclusion criteria: 1. diagnosis of type 1 and/or type 2 diabetes 2. diagnosed inflammatory bowel disease (ibd) 3. current diagnosis of psychiatric disease/s or syndromes 4. current diagnosis of neurodegenerative disease 5. current pregnancy or breastfeeding 6. history of complicated gastrointestinal surgery 7. systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion 8. regular use of any non-steroidal anti-inflammatory drug (nsaid) for the last 2 months 9. consumption of any nsaid within 3 days of sample collection 10. current (or within the last 4 weeks prior to study start) use of probiotic supplementation 11. any condition or intake of medication which could substantially interfere with the outcome of the study, as decided by the principal investigator's discretion 12. after being included in the study and until collection of faecal material, starting any medication or treatment that could potentially influence the study participation and/or study analysis

Keywords: hyperuricemia
effectiveness of treatment with rich platelet fibrin (prf) vs gold standard in patients undergoing knee replacement

Conditions: Knee Disease

Summary: randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with platelet-rich-fibrin compared to the gold standard (without platelet-rich-fibrin) in patients undergoing knee replacement.


Eligibility criteria:
inclusion criteria: * males or females undergoing a total knee prosthesis. * willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. * hb \> 11 g/dl; platelet value \> 150.000 plt/mmc; * patients with non clinical alteration of ecg; * signature of informed consent; exclusion criteria: * patients incapable of understanding and of wanting; * systemic disorders such as diabetes, rheumatic diseases; * patients with malignancy; * thyroid metabolic disorders ; * abuse of alcohol, drugs and pharmaceutical drugs * body mass index \> 40;
rrisc study: reduction of restenosis in saphenous vein grafts with cypher sirolimus-eluting stent.

Conditions: Stable Angina; Unstable Angina; Coronary Artery Disease; Saphenous Vein Graft Disease

Summary: context: sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials. objective: to evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts. design: double-blind randomized controlled non-industry-sponsored trial. setting: a single-center tertiary-care referral hospital. patients: all patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. all patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months. main outcome measure: primary end-point is 6-months angiographic in-stent late loss. secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).


Eligibility criteria:
inclusion criteria: * 18 to 85 years-old * clear signs and/or symptoms of stable or unstable angina or documented silent ischemia * one or more de-novo target lesions (\>50% diameter stenosis by visual estimate) localized in one or more diseased svg with a reference vessel diameter (rvd) included between 2.5 and 4.0 mm (by visual estimate) * signed informed consent. exclusion criteria: * myocardial infarction within the previous 7 days * documented left ventricular ejection fraction \<25% * impaired renal function (creatinine \>3.0 mg/dl) at the time of treatment * outflow obstruction of the graft due to distal anastomotic stenosis * totally occluded saphenous vein graft * brachytherapy treatment in the index vessel before enrollment * life expectancy less than 12 months * known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus * hemorrhagic diatheses * a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.
vascular changes following forearm loop arteriovenous graft placement

Conditions: Chronic Kidney Disease

Summary: this study will determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement and the timing of these changes.

the purpose of this study is to determine whether upper arm vessels increase in size following forearm loop arteriovenous graft placement, and if they do, characterize the timing of these changes.

Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 19 years 2. planned forearm loop arteriovenous graft placement for hemodialysis or forearm loop arteriovenous graft placed within the previous 7 days. 3. cephalic and/or basilic vein diameter greater than or equal to 2.5 mm at the antecubital fossa to the axilla prior to avg placement exclusion criteria: 1. age less than 19 years 2. hemodialysis access other than forearm loop graft surgery placement 3. cephalic and/or basilic vein diameter less than 2.5 mm at any point from the antecubital fossa to the axilla 4. prior hemodialysis access surgery in the arm receiving the forearm loop graft

Keywords: hemodialysis arteriovenous graft
therapeutic control of aspirin-exacerbated respiratory disease with ifetroban

Conditions: Nasal Polyps; Asthma, Aspirin-Induced; Aspirin-exacerbated Respiratory Disease; Aspirin-Sensitive Asthma With Nasal Polyps

Summary: the overall aim of the study is to determine the efficacy of oral ifetroban, a novel antagonist of t prostanoid (tp) receptors, as a treatment for patients with aspirin-exacerbated respiratory disease (aerd).

the protocol involves a 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban in patients with aerd. at the end of the 4-week treatment phase (ifetroban or placebo) each subject will undergo a graded oral aspirin desensitization procedure in order to initiate high-dose aspirin therapy, which is standard-of-care at our institution and is the only available therapy known to modify the course of aerd.

Eligibility criteria:
inclusion criteria: 1. history of aerd, defined as meeting the diagnostic triad with: * history of physician-diagnosed asthma and * history of physician-diagnosed nasal polyposis and * history of pathognomonic reactions aspirin or other nonselective cyclooxygenase (cox) inhibitors. 2. stable asthma (post-bronchodilator forced expiratory volume at one second (fev1) of ≥70%, no glucocorticoid burst for at least 2 weeks prior to visit 1, and no hospitalizations or er visits for asthma for at least the prior 6 months) 3. age between 18 and 70 years 4. no current smoking (not more than one instance of smoking in the last 3 months) 5. non-pregnant exclusion criteria: 1. hypersensitivity to montelukast 2. current use of zileuton 3. history of bleeding diathesis or use of anticoagulant or antiplatelet drugs 4. current use of any nsaids aside from the aspirin provided during the study 5. current use of beta blockers 6. use of any biologics within the last 4 months prior to initiating the study