Kornimate/medical-research-clean huggingface dataset:
efficacy of human placental graft in diabetic foot ulcers

Conditions: Diabetic Foot

Summary: to determine the efficacy of full-thickness placental allograft in chronic wound healing

to evaluate the efficacy of revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (dfus) as compared to the current standards of wound care treatment

Eligibility criteria:
inclusion criteria: * male and female patients * 18-80 years old * diagnosis of type 1 or 2 diabetes mellitus * foot ulcers \>1cm2 and \<25cm2 for 4 weeks or more prior to enrollment * able to give consent to participate * compliance with all aspects of protocol and follow-up exclusion criteria: * male and female patients younger than 18 years old * male or female patients older than 80 years old * smoking, and any additional health risk factors contraindicated with revita use * involvement in any other ongoing studies
bio-clinical evolutive dynamic in patients suffering from communitary septic shock (biosepsis)

Conditions: Immunocompetent Patient on Septic Shock

Summary: septic shock is a frequent pathology responsible for over 30000 deaths/year in france. its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. we intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. our goal is to obtain quality data, repeated over time, by limiting the technical variability.

the aim is to obtain precise data on the dynamics of cytokines, oxydative stress and hormonal response on immunocompetent adults during septic shock.

Eligibility criteria:
inclusion criteria: * patient over 18 years admitted in icu. * clinical evidence of infection, suspected or proved, during the 48hrs following the hospital entry. * systemic inflammatory response syndrome. * shock defined as arterial hypotension (\<90mmhg)not responding to adequated filling. exclusion criteria: * minors * patient under guardianship or trusteeship * pregnant or lactating women * not affiliated to the social security * deprived of liberty by court decision * patients hospitalised without their approval * shock related to another cause than infection * long term corticothérapy * on-going chemiothérapy, aids * bedridden patient

Keywords: septic shock inflammatory process cytokines hormonal response oxydative stress
statin intensity to prevent coronary artery vasculopathy after heart transplantation

Conditions: Vasculopathy

Summary: the investigator's propose to conduct an open-label randomized controlled trial to determine if higher intensity statin (hs) can reduce cav in comparison to lower intensity statin (ls) after ht. all consecutive patients that meet eligibility criteria will be approached for participation. after heart transplantation, participants (n=70) will be randomized in a 1:1 manner to either hs or ls. study participation will be for 2 years from the time of randomization. study outcomes will be compared by research staff blinded to statin group assignment.

outcomes after heart transplantation (ht) are limited by development of coronary allograft vasculopathy (cav). cav comprises of macro- and microvascular coronary disease and is the third leading cause of graft dysfunction and late mortality following ht. the pathophysiology of cav is multifactorial and major pathways that are implicated include inflammation and dyslipidemia. these pathways are inhibited by statins which serve as the mainstay of cav prevention. the international society of heart and lung transplantation (ishlt) guidelines recommend administration of low intensity statins (ls) due to a potential drug-drug interaction (ddi) with calcineurin inhibition (cni) therapy. this ddi is related to concurrent use of an older generation cni, cyclosporin a (csa). csa inhibits intestinal p-glycoprotein to reduce the efflux of statin into the gastrointestinal tract, thereby increasing statin levels in the blood and risk of myopathy. however, the current generation of cni being utilized in most patients, tacrolimus, does not inhibit p glycoprotein and may not impact statin levels after ht. despite use of ls, the residual risk of cav development is elevated with nearly half of the patients having angiographic detection 5 years after ht. however, angiography is limited by its inability to detect microvascular disease and invasiveness. early cav is also detectable by non-invasive imaging with cardiac positron emission tomography (cpet) through measurement of myocardial flow reserve (mfr). mfr assesses total burden of macro- and microvascular disease and is well correlated with invasive measures of cav and prognosis. the protective and inhibitory effects of statins are proportional to their intensity with higher intensity statins (hs) leading to a greater reduction in low density lipoprotein (ldl) and inflammatory markers such as c-reactive protein (crp) in comparison to ls. despite these potentially beneficial effects of hs, ls remains the agent of choice for primary prevention of cav after ht in the absence of a randomized controlled trial (rct).

Eligibility criteria:
inclusion criteria: * waitlisted for heart transplantation * capacity to provide informed consent exclusion criteria: * history of statin allergy or intolerance * hepatic dysfunction * redo heart transplant * awaiting combined heart and liver transplantation
developing a self-management program for people with depression and chronic medical illness

Conditions: Depression

Summary: this study seeks to adapt an existing chronic disease self-management program for people with both chronic medical illness and depression.

depression is a common but serious disorder that affects millions of people every year. depression can severely impact people's lives, causing them to often feel sad and hopeless as well as affecting their sleep patterns, concentration, and energy levels. treatment typically includes a combination of antidepressant medication and talk therapy. this study will evaluate the effectiveness of an adapted group education program typically used for chronic medical illness in improving the health status, health behaviors, and use of health care services among people with depression and a chronic illness. participants in this open-label study will attend a group education program used to manage chronic medical illness. group sessions will be held for 2.5 hours, once a week, for 6 weeks. group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions. participants will also complete two surveys: one at the beginning of the study and one at the end. the first survey will ask basic questions related to participants' health status and any feelings of stress, anxiety, or sadness. the second survey will include a brief interview that will require participants to describe their experience in the group sessions and to suggest ways of improving the program to better accommodate people with depression and chronic illness. responses to questions will be used to enhance the effectiveness of the group education program for treating people with both depression and a chronic medical condition.

Eligibility criteria:
inclusion criteria for patients: * currently attending the edward r. roybal comprehensive health center or the lac+usc outpatient department for primary care * english- or spanish-speaking * screens positive for major depressive disorder or minor depression based on the prime md phq-9 * suffers from a chronic medical illness (e.g., lung disease, asthma, emphysema or trouble breathing; heart disease or heart problems; high blood sugar or diabetes; arthritis or rheumatism) inclusion criteria for group leaders: * prior experience facilitating a chronic disease self-management program within 6 to 9 months of study entry (including the groups held at roybal comprehensive health center) exclusion criteria for patients: * acutely suicidal * screens positive for bipolar disorder, psychotic disorder, or cognitive impairment disorder * history of alcohol or drug abuse

Keywords: self-management programs chronic medical illness
effect of steroids on post-tonsillectomy morbidities

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting

Summary: this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.

the effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. however, this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. one group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.

Eligibility criteria:
inclusion criteria: * patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study. exclusion criteria: * patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.

Keywords: dexamethasone prednisolone tonsillectomy nausea pain, postoperative postoperative nausea and vomiting randomized controlled trial post-tonsillectomy pain delayed feeding
treatment study of vitamin d deficiency in adolescents

Conditions: Vitamin D Deficiency

Summary: to compare the efficacy of two high dose vitamin d3 regimens (5,000 iu daily vs. 50,000 iu weekly) used clinically for the treatment of vitamin d deficiency versus a low dose of vitamin d3 used for supplementation (1,000 iu daily) in a clinical sample of predominantly hispanic and black adolescents with vitamin d deficiency \[25(oh)d level \<20 ng/ml\] by assessing change in 25(oh)d levels before and after 8 weeks of treatment. to compare the effects of vitamin d repletion \[25(oh)d level \>20 ng/ml\] on selected musculoskeletal, cardiometabolic and immune markers in predominantly hispanic and black adolescents with vitamin d deficiency \[25(oh)d level \< 20 ng/ml\]. hypothesis 1: increase in vitamin d level will be associated with improvement in musculoskeletal, cardiometabolic, and immune markers including blood pressure, waist circumference, musculoskeletal symptoms, asthma severity and hand-grip strength.

vitamin d is an essential nutrient and pro-hormone that has garnered widespread attention over the past decade for both its known and theorized health benefits. patients, clinicians and researchers have all been alerted to the increasing prevalence of vitamin d deficiency (defined as level of 25(oh)d \<20 ng/ml) and the significance of the extra-skeletal health effects of vitamin d. aside from the skeletal impacts of vitamin d, there has been recent evidence about potential health benefits of vitamin d related to the multiple extra-skeletal roles of this hormone. in fact, vitamin d receptors are found in many organs including brain, heart, skin, small intestine, gonads, prostate and breast as well in almost all nucleated cells including osteoblasts, activated t and b-lymphocytes, and b islet cells. studies in children and adolescents as well as in adults show associations of vitamin d deficiency with cardiovascular risk factors, musculoskeletal health, asthma, and autoimmune diseases. while vitamin d deficiency is quite prevalent, adolescents who are obese or who are darker skinned are consistently shown to have higher rates of vitamin d deficiency than lean and lighter skinned adolescents. treatment of vitamin d deficiency and maintenance of sufficient levels in adolescents are largely under-studied leaving patients and clinicians without clear evidence-based guidelines to follow. the goal of this study is to compare the efficacy of different treatment regimens for vitamin d deficiency in our population of predominantly minority adolescents and to examine the effect of correction of vitamin d deficiency on selected extra-skeletal targets of vitamin d action including musculoskeletal, cardiometabolic, and immune function.

Eligibility criteria:
inclusion criteria: * age 13-20 exclusion criteria: * currently receiving treatment for hypovitaminosis d * hepatic or renal disease * metabolic rickets * inability to complete the questionnaire

Keywords: adolescents minority
a phase 1 study of xl019 in adults with polycythemia vera

Conditions: Polycythemia Vera

Summary: the purpose of this study is to evaluate the safety and tolerability of the jak2 inhibitor xl019 administered orally in adults with polycythemia vera.


Eligibility criteria:
inclusion criteria: * the subject has a diagnosis of polycythemia vera (pv), and has failed, or is intolerant of, standard therapies or refuses to take standard medications. * the subject is ≥18 years old. * the subject has an eastern cooperative oncology group (ecog) performance status of ≤2. * the subject has adequate organ function. * subjects who have received phlebotomy due to pv must have documented phlebotomy history for 12 weeks prior to enrollment. * the subject has the capability of understanding the informed consent document and has signed the informed consent document. * sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study. * female subjects of childbearing potential must have a negative pregnancy test at screening. * the subject has had no other diagnosis of malignancy or evidence of other malignancey for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix). exclusion criteria: * the subject has received treatment for pv within 14 days prior to first dose of xl019 * the subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias. * the subject is pregnant or breastfeeding. * the subject is known to be positive for the human immunodeficiency virus (hiv). * the subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

Keywords: polycythemia vera pv
use of a novel contact force sensing catheter for af ablation - impact of tacticath on dormant conduction across the pulmonary veins

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to collect information about the success rate of atrial fibrillation (af) ablation procedures using the contact force data from the tacticath quartz ablation catheter.

atrial fibrillation is a condition in which the upper chambers of the heart (the atria) begin to quiver (shake rapidly with small movements) instead of beating in a normal rhythm. this condition can cause blood to remain in the atria instead of moving to the lower heart chambers. af can cause a number of other health problems and can decrease your quality of life. treatments for af can include surgery, implantable devices, ablation and medication, to name a few. an ablation is a procedure that creates scar tissue in the heart to interrupt irregular heart rhythms and prevent them from coming back. the ablation procedure uses tools called catheters to treat the af. ablation catheters are thin, flexible plastic tubes that use electrical energy to create scars in the heart. the amount of force applied to the heart tissue where the catheter touches (called the contact force) might help determine the success of the ablation procedure. this study would help to determine whether or not the contact force makes a difference in an effective ablation. you will be tested on both sides, at the end of the procedure to see if any problem persists. participants will be in this study for about 3 months. all visits in this study will correspond to standard of care visits.

Eligibility criteria:
inclusion criteria: * patients undergoing an initial af ablation procedure * able to sign informed consent and complete the 3 month follow up exclusion criteria: * severe copd and is unable to receive adenosine therapy during the procedure
cpg 7909 injection in non-small cell lung cancer

Conditions: Carcinoma, Non-Small Cell Lung

Summary: eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus cpg 7909 injection or chemotherapy alone. protocol therapy will be administered until disease progression or intolerable toxicity. cpg 7909 injection will be administered subcutaneously, on weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on week 1 (day 1). patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (stage iiib or iv according to ajcc). * patients must have measurable disease according to the recist criteria. exclusion criteria: * prior treatment with chemotherapy; patients may have received prior radiotherapy. * patients with suspected or known cns metastases.

Keywords: immunotherapy lung cancer
six minute walking test and breath-holding

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to compare the relationship between breath-hold time and the distance in a six minute walking test in chronic obstructive pulmonary disease population.


Eligibility criteria:
inclusion criteria: * stable chronic obstructive pulmonary disease exclusion criteria: * contra-indication for six minutes walking test * difficulty to walk * musculoskeletal disorder
safety and immunogenicity of two doses of monovalent inactivated influenza vaccine that is adjuvanted with mf59c.1 (mf59) and uses a surface antigen from a potential pandemic virus strain candidate (h5n1) in adult and elderly subjects using four different vaccination schedules

Conditions: Pre-pandemic Influenza Vaccine

Summary: the present study will evaluate the immunogenicity, safety and immunogenicity of two doses of monovalent inactivated influenza vaccine that is adjuvanted with mf59c.1 (mf59) and uses a surface antigen from a potential pandemic virus strain candidate (h5n1) in adult subjects.


Eligibility criteria:
inclusion criteria: * subjects aged 18 to 60 years of age who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol; * in good health as determined by: * medical history, * physical examination, * clinical judgment of the investigator; * able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for all study visits. exclusion criteria: * previous receipt of any h5 vaccine; * receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study; * experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days; * experienced fever (defined as axillary temperature 38.0°c) within 3 days prior to visit 1; * pregnant or breastfeeding; * females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study. adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., iud), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry; * any serious disease, such as: * cancer, * autoimmune disease, * diabetes mellitus, * chronic pulmonary disease, * acute or progressive hepatic disease, * acute or progressive renal disease; * surgery planned during the study period; * bleeding diathesis; * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine; * history of any neurological symptoms or signs following administration of any vaccine, or anaphylactic shock following administration of any vaccine; * known or suspected impairment/alteration of immune function, for example, resulting from: * receipt of immunosuppressive therapy (any corticosteroid therapy * receipt of immunostimulants, * high risk for developing an immunocompromising disease

Keywords: influenza vaccine