Kornimate/medical-research-clean huggingface dataset:
lymphocyte count, atg dose and incidence and severity of gvhd in pediatric recipients of hsct

Conditions: Hematopoietic Stem Cell Transplantation

Summary: despite increasing success rate in hematopoietic stem cell transplantation (hsct) control of graft versus host disease (gvhd) remains a significative burden in mortality and morbidity. a lot of strategies could lower the incidence and gravity of the disease and immunosuppressive treatment as gvhd prophylaxis still represent the main method. although immunosuppressive treatment showed a good effect on gvhd mortality a lot of studies also highlight an increase of relapse and infection related mortality that jeopardize the effect on overall survival of hsct recipient. using anti thymocyte globulin (atg) as gvhd prophylaxis shares the same double-edge effect as other immunosuppressive treatment although is still unclear how manage dose and timing of the infusion to minimize promoting effect on infections and maximize protective effect on gvhd. biological effect of atg lead to a dose- related delay in all class of t-cell reconstitution but our data are mostly from adult studies with high doses between 30 and 60 mg/kg due to the more important burden of gvhd in hsct adult population. as for other treatment in hsct conditioning we would like to study a personalized approach for atg treatment: some studies focus on tuning of atg dose for kilos but previous evidence showed that the same dose could made too little or too much immunosuppressive effect for different patients, even though same age and same stem cell source.


Eligibility criteria:
inclusion criteria: 1. age of the patients between 0 and 17 2. diagnosis of hematological or oncological disease undergoing allogeneic bone marrow transplantation 3. patients undergoing myeloablative conditioning 4. patients that received atg as gvhd prophylaxis 5. patients whose consent has already been acquired for the processing of data for research purposes 6. minimum follow-up of 12 months exclusion criteria: 1. bacterial and / or fungal infection present at the time of bone marrow transplantation 2. use of thymoglobulin in the 3 months prior to transplantation 3. allergy and / or intolerance to the active substances or excipients contained in thymoglobulin

Keywords: gvhd prophylaxis pediatric patients hematopoietic cell transplantation
cohort study of patients with type 1 diabetes registered with mobile application in china

Conditions: Type 1 Diabetes

Summary: for last decade, the innovation of mobile health platform has brought new opportunities for disease management. previous studies have shown that health management programs based on mobile platforms for patients with diabetes can improve patients' glucose control, self-management ability and quality of life. type 1 diabetes mellitus (t1dm) due to its characteristics needs long-term linkage care throughout the lifespan cycle of patients. therefore, this study intends to construct a prospective and open t1dm cohort based on mobile application and platform, to deliver home-community-hospital joint management for patients, and to provide follow-up online or offline every 3 months lasting for 10 years. mainly, the objective of this study is to observe the blood glucose control outcome of t1dm patients. secondly, the control of comprehensive metabolic indicators such as blood pressure and blood lipid, occurrence and progression of acute and chronic complications, and psychosocial status were included as well, expecting to provide scientific evidence for continuously improving the quality of t1dm management.


Eligibility criteria:
inclusion criteria: * at least 12 years old; * diagnosed as type 1 diabetes according to world health organization (who) criteria in 1999; * be able to use smart mobile phones; * informed consent and voluntary participation. exclusion criteria: * secondary diabetes; * complicated with malignant diseases, such as cancer, hepatic and renal failure; * complicated with cognitive impairment or mental illness; * be pregnant or lactating at the time of enrollment.

Keywords: cohort study type 1 diabetes mobile home-community-hospital china
papilloma virus vaccine therapy in treating young patients with recurrent papilloma of the larynx

Conditions: Precancerous Condition

Summary: rationale: vaccines made from papilloma virus cells may make the body build an immune response to and kill papilloma cells. purpose: phase ii trial to study the effectiveness of papilloma virus vaccine in treating young patients with recurrent papilloma of the larynx.

objectives: i. determine the immune response in patients with juvenile papilloma of the larynx treated with autogenous vaccine derived from each patient's own tumor. outline: patients receive autogenous papilloma vaccine intradermally and subcutaneously weekly for 20 weeks. projected accrual: not specified

Eligibility criteria:
disease characteristics: diagnosis of severe recurrent juvenile papilloma of the larynx requiring surgery at least 4 times per year condition must have existed for more than 1 year patient characteristics: age: 1 and over performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified prior concurrent therapy: see disease characteristics

Keywords: lung papilloma
evaluation of the safety of and immune response to an hiv vaccine in healthy adults

Conditions: HIV Infections

Summary: this study will examine the safety and immune response to a two-part hiv vaccine. healthy volunteers who are at low risk of hiv infection will receive either active vaccine or a placebo.

the purpose of this study is to examine the safety and immunogenicity of a candidate vaccine strategy for hiv prophylaxis using a dna-prime plus recombinant fowlpox boost. the dna plasmid and fowlpox vector contain hiv genes. however, these vaccines contain only some hiv genes and cannot themselves cause hiv or aids. eligible volunteers at low risk of hiv infection will be randomized to receive either active vaccine or placebo injections at day 0, week 4, and week 8. intensive immunologic and safety monitoring will be done during the first 16 weeks of the study. follow-up will continue to week 52.

Eligibility criteria:
inclusion criteria * hiv negative. * acceptable methods of contraception. exclusion criteria * identifiable risk behavior for hiv infection, including: sexual partners of hiv positive people, sexual intercourse with a partner of unknown hiv status if that partner is reported to be at higher risk for hiv infection, gay men reporting any unprotected anal intercourse with partners of unknown status in the 12 months preceding study entry, individuals diagnosed with a sexually transmissible infection (sti) in the 12 months preceding entry that may have been acquired through anal or vaginal intercourse, individuals reporting sharing of injecting equipment in the last 12 months. * hiv candidate vaccines in a previous hiv vaccine trial. * live attenuated vaccines within 60 days prior to entering the study. whole killed, toxoid, or sub-unit vaccines (e.g., influenza, pneumococcal, tetanus, and hepatitis b) are not exclusionary within 4 weeks prior to the scheduled experimental hiv vaccines. * hypersensitivity to egg products or a known history of anaphylaxis or any other serious adverse reactions to vaccination. * history of serious allergic reaction requiring hospitalization or emergency medical care (e.g., stevens-johnson syndrome, bronchospasm, or hypotension) to any substance. * significant illness requiring immunomodulatory or cytotoxic therapy. * history of cancer unless there is evidence of surgical excision followed by a sufficient observation period to give a reasonable assurance of cure. * blood products or immunoglobulins within 6 months prior to entering the study. * experimental or investigational agents within 30 days prior to entering the study. * recreational and/or therapeutic drug use that might compromise the study participant's safety. * medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol. * pregnant or lactating women.

Keywords: hiv seronegativity hiv preventive vaccine
fasudil eye drop in retinopathy of prematurity(rop)

Conditions: Retinopathy of Prematurity

Summary: eligible eyes are randomly assigned into two groups. group a receive fasudil eye drops (concentration 0.5 percent) twice daily. group b, receive artificial tears drop with the same frequency. retinal specialists who are expert in retinopathy of prematurity field will perform fundus examination regularly. the examiners are blind. the progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. the topical eye drops are used until the retinal vascularization are complete (45 week after lmp) or the patient needs to be treated.


Eligibility criteria:
inclusion criteria: * premature infants who are candidate for retinopathy of prematurity (rop) screening with rop type 2 exclusion criteria: * serious systemic problems * other ocular problems except rop
feasibility study evaluating the safety and efficacy of the renal stimulation by direct wire pacing, during renal denervation procedure

Conditions: Essential Hypertension

Summary: the goal of this feasibility study is to evaluate the safety and efficacy of the renal stimulation (rns) by direct wire pacing, during renal denervation (rdn) procedure in patient candidate for renal denervation with the paradisetm system. the main questions it aims to answer are: * is the rns before rdn a straightforward method, allowing quantification of the renal sympathetic traffic? * does the rns increase blood pressure (sbp), and is this increase significantly blunted after rdn? * does the 3-month 24h sbp decrease correlated with the rns-induced sbp change before rdn? * can the difference between rns-induced sbp rise before and after rdn be used as a procedural endpoint for rdn? participants will be asked for their agreement to conduct an rns before and after the rdn. no additional experimental procedure will be added to the standard of care.


Eligibility criteria:
inclusion criteria: * patient willing and able to comply with the protocol and has provided written informed consent. * age ≥18 * patient candidate for renal denervation with the paradisetm system based on physician's assessment. * patients affiliated to a social security system exclusion criteria: * patients who meet any of the contraindications listed in the instructions for use of paradisetm ultrasound renal denervation system will be excluded: * renal arteries diameter \ 8 mm * patient with relevant renal artery disease (% diameter stenosis \> 30%, aneurysm or fibromuscular disease) * stented renal artery * iliac/femoral artery stenosis precluding insertion of the paradisetm catheter * known allergy to contrast medium * patient with known secondary cause of hypertension * patient with contraindication to chronic anticoagulation therapy or heparin * patient with type 1 diabetes mellitus * patient with more than one accessory renal artery * woman currently pregnant or breastfeeding * patient with other concomitant conditions that may adversely affect the patient or the study outcome * patient with mental or physical inability to participate in the study * patient under judicial protection, tutorship, or curatorship

Keywords: renal stimulation renal denervation procedure
cardioband with transfemoral delivery system

Conditions: Mitral Regurgitation

Summary: to evaluate the performance and safety of the cardioband adjustable annuloplasty system for repair of functional mitral regurgitation.


Eligibility criteria:
inclusion criteria: * age \> 18 years * moderate to severe functional mitral regurgitation (mr) * symptomatic patients (nyha classii-iv) despite optimal medical therapy , including cardiac resynchronization (crt) if indicated. * left ventricle ejection fraction (lvef) ≥ 25%, lvedd ≤ 65mm * subject is high risk to undergo mitral valve (mv) surgery (as assessed by a surgeon and a cardiologist, at the site) * transseptal catheterization and femoral vein access is determined to be feasible * subject is able and willing to give informed consent and follow protocol procedures exclusion criteria: * active bacterial endocarditis * severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue * heavily calcified annulus or leaflets * subjects in whom transesophageal echocardiography is contraindicated * untreated clinically significant coronary artery disease (cad) requiring revascularization * crt implant within 3 months prior to procedure * any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months * cerebrovascular accident (cva) or transient ischemic attack (tia) within 6 months or severe carotid stenosis (\>70% by ultra sound) * renal insufficiency requiring dialysis * life expectancy of less than twelve months * subject is participating in concomitant research studies of investigational products * mitral valve anatomy which may preclude proper device treatment * right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation

Keywords: mitral valve annuloplasty
safety & efficacy of an antibacterial protein molecule applied topically to the nostrils of volunteers and patients

Conditions: Infectious Disease; Bacterial Infections

Summary: the purpose of this study is to determine whether the antibacterial protein p128 is (i) safe and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis, (ii) is it effective in reducing the nasal carriage of pathogen (staphylococcus aureus) in humans.

staphylococcus aureus with acquired multiple-drug resistance poses an increasing problem in both hospital and community settings. s. aureus is known to cause infections ranging in severity from skin infection to systemic bacteremia. as nasal colonization is the principal ecological niche for these bacteria and has been shown to be a significant risk factor in developing s. aureus infection, it is of importance to develop an efficient therapy that is able to clear this bacterium from human nostrils. in-vivo studies have shown that p128 treatment is efficacious in reducing and decolonizing mrsa bacteria from rat nostrils. pre-clinical safety studies in animal models indicated no test drug related toxicity signs at the site of application or systemically. the present clinical trial is conducted in four parts. part a consists of safety and tolerability studies in 4 cohorts of 3 healthy subjects who are administered a single dose of three escalating concentrations of the drug and placebo intra-nasally. part b consists of safety \& tolerability as in part a but with multiple doses (3 doses/day for 5 days). part c comprises of safety/tolerability as well as efficacy studies in chronic kidney disease patients stable on dialysis who are nasal carriers of s.aureus or mrsa on a treatment regimen as in part b. part d comprises of safety and efficacy studies in any patient who are nasal carriers of s.aureus or mrsa with single dose of 3 escalating concentrations of the drug and placebo intra-nasally.

Eligibility criteria:
inclusion criteria: * healthy human volunteer * any patient clinically stable who are nasal carrier of s. aureus or mrsa including chronic kidney disease patients stable on dialysis exclusion criteria: * presence of active systemic bacterial infection of any nature not cured at least 4 weeks before enrollment. * systemic or intra-nasal anti-bacterial treatment during four week period before enrollment * pregnancy, breast feeding during the study duration * participation in any other intervention study during the past three months

Keywords: s.aureus methicillin resistant s.aureus (mrsa) nasal carrier status prophylaxis
reduction of mortality prior to and during the first 90 days of dialysis through a renal rehabilitation program

Conditions: Chronic Kidney Disease; End Stage Kidney Disease; Cardiovascular Disease

Summary: the mortality rate of treated patients with end stage renal disease(esrd)is 22 deaths patient-years at risk in 2006. incident patients with esrd are most vulnerable within the first 90 days of dialysis, with an annualized mortality rate of 50 deaths/100 patient years. the vast majority of these deaths are due to cardiovascular causes. as cardiac rehabilitation programs have shown a 20% reduction in one year overall mortality rate post myocardial infarction the investigator proposes that a similar type of rehabilitation program will also have a benificial effect on morbidity and mortality in patients with chronic kidney disease(ckd)and esrd.the overall goal of this project is to study whether a renal rehabilitation program based on guided exercise implemented in patients with stage iii and stage iv ckd can influence the mortality rate of these patients prior to and during the first 90 days of dialysis hypothesis:the application of a guided exercise program (renal rehabilitation) instituted in patients with stage iii or stage iv ckd will decrease the mortality rate prior to the initiation of renal replacement therapy. hypothesis:the application of renal rehabilitation during the late stages of ckd will decrease the mortality risk during the first 90 days of renal rehabilitation therapy. hypothesis:a guided exercise program will have an immediate and prolonged effect on activity levels, mental health and adaption to chronic illness in patients with advanced ckd.


Eligibility criteria:
inclusion criteria: * greater than 18 yo * stage iii ckd (gfr\<60ml/min) * stage iv ckd (gfr\<30ml/min) exclusion criteria: * active angina pectoris * lower extremity amputation with no prosthesis * orthopedic disorder severly exacerbated by activity * chronic lung disease resulting in significant shortness of breath or oxygen de-saturation at rest * cerebro cascular disease manifested by ongoing tias * malignant carcinoma

Keywords: chronic kidney disease end stage renal disease exercise cardiovascular disease
the role of gut microbiota in heart failure and pre-heart failure with preserved ejection fraction

Conditions: Heart Failure

Summary: gut microbiota play an important role in normal cardiovascular function and pathophysiology of cardiovascular diseases. patients with heart failure (hf) have substantial hemodynamic changes which lead to intestinal hypoperfusion and congestion and eventually change gut morphology, permeability, function and composition of gut microbiota and cause translocation of microbial and endotoxins into the blood stream. additionally, metabolites derived from gut microbiota modulate the pathophysiology of hf. patients with hf have intestinal overgrowth of pathogenic bacteria and increased gut permeability. accumulating evidence demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular events. taking the strong association of gut microbiota with hf into account, it is reasonable to speculate that gut microbiota could contribute to the progression of pre-hf with preserved ejection fraction (pre-hfpef) to hf with preserved ejection fraction (hfpef). pre-hfpef remains poorly understood, yet has high prevalence and a significantly high risk for death in comparison to patient without pre-hfpef. we hypothesize that altered gut microbiota is involved in the initiation and establishment of hf and pre-hfpef.

the research study will initially enroll 50 subjects without hf as normal controls,120 subjects with history of hf and 50 subjects with pre-hfpef to characterize gut microbiota. the subjects will provide blood samples and a stool sample.

Eligibility criteria:
inclusion criteria: * competent and willing to provide consent * control subjects with normal heart function * subjects with history of hf * subjects with impaired ventricular relaxation and/or elevated left ventricular end diastolic pressure measured by echocardiography and/or catheterization, yet has not had hf clinical presentations exclusion criteria: * intestinal surgery, * inflammatory bowel disease, * celiac disease, * lactose intolerance, * chronic pancreatitis or * other malabsorption disorder

Keywords: pre-clinical diastolic dysfunction (pre-hfpef)
laparoscopic supracervical hysterectomy and sacropexy versus hysteropexy study

Conditions: Uterus Prolapse

Summary: the purpose of this study is to compare the operative, anatomic functional outcome as well as the subjective outcome of laparoscopic supracervical hysterectomy and sacropexy compared to laparoscopic hysteropexy (conserving the uterus). the investigators expect that both laparoscopic procedures are equal in regards to operation time, complication rate, anatomic and functional outcome as well as subjective outcome.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * symptomatic uterus prolapse (uterus \< 300g) * patient able to sign the informed consent and to fulfil the follow up visits exclusion criteria: * indication: pathologies of the uterus (postmen. bleeding, high endometrium at ultrasound (\>5 mm), abnormal pap smear in the last 5 years, bleeding anomalies in premenopausal patients * general medical contraindications to a surgical operation * tumor/ malignant disease * bacterial infection at time of surgery * drug or medication abuse at time or just before surfer * disease which would make a correct assessment of the patient impossible (e.g. psychiatric condition) * known hypersensitivity to the implanted materials * immaturity, inability to answer/understand questions * planned pregnancy * participation to other studies (drugs or medical techniques) which could influence the results of this study

Keywords: uterus prolapse laparoscopic sacropexy laparoscopic hysteropexy