Kornimate/medical-research-clean huggingface dataset:
apol1 gene variants in african american kidney transplant recipients

Conditions: Transplant;Failure,Kidney; Kidney Disease; Kidney Failure, Chronic

Summary: aim 1: determine if there is an association between the apol1 risk variants and allograft survival and function in african americans aim 2: determine if there is an association between the presence of apol1 risk variants in an african american kidney transplant recipient and the risk of recurrent disease aim 3: investigate mechanisms of apol1 associated kidney disease by prospectively following african american kidney transplant recipients throughout their clinical course.


Eligibility criteria:
aim 1: inclusion criteria: * self-reported african american * 18 years or older * kidney transplant within 12 years aim 2: inclusion criteria for patients with recurrent disease: * self-reported african american * 18 years or older * kidney transplant within 12 years * recurrent or de novo glomerular disease on allograft kidney biopsy inclusion criteria for control group: * self-reported african american * 18 years or older * kidney transplant within 12 years * end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy exclusion criteria for control group: * clinical evidence of recurrent disease (presence of proteinuria, hematuria, creatinine \>2) aim 3: inclusion criteria: * self-reported african american * 18 years or older * scheduled living kidney transplant
trial comparing atropine to atropine plus a plano lens for the sound eye for amblyopia in children 3 to <7 years old

Conditions: Amblyopia

Summary: the purpose of the study is: * to compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old. * to provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.

atropine is an effective treatment of moderate amblyopia. reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. if the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. it also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs. little is known about the pharmacologic treatment of severe amblyopia. this study will provide important prospectively determined outcome data at little additional expense. in a study conducted by the pediatric eye disease investigator group, a randomized trial comparing daily atropine versus weekend atropine for moderate amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. it is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye. the study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. the two treatment regimes for the 18 week primary treatment period are: 1) atropine 1% once each weekend day in the sound eye and 2) atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.

Eligibility criteria:
inclusion criteria: * patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both. * visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logmar lines. * spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable. exclusion criteria: * atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment * no myopia in amblyopic eye

Keywords: amblyopia atropine plano lens
acupuncture treatment for hot flashes study

Conditions: Prostate Cancer

Summary: patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered acupuncture as an investigational intervention. the treatment is performed twice a week for four weeks, then once a week for the following six weeks

patients with prostate cancer who are / were treated with hormonal treatment and developed hot flashes as a side effect are offered acupuncture as an investigational intervention. the treatment is performed twice a week for four weeks, then once a week for the following six weeks. acupuncture was done according to specific guidelines and mapping.

Eligibility criteria:
inclusion criteria: * treatment for prostate cancer using hormonal ablation therapy * average of three or more hot flashes a day * performance status (karnofsky ≥ 60) * patients must be ≥ 18 years of age * no other clinically significant disease * signed study-specific consent form prior to study entry exclusion criteria: * initiation of a new chemotherapy regimen, immunotherapy; or initiation/ cessation of hormonal therapy during the study or for 3 weeks before the start of the study * pharmacological treatment of hot flashes or use of selective serotonin reuptake inhibitors (unless the dose and patients' condition have been stable for 4 weeks) * skin infections * patients who had acupuncture treatment in the 6 weeks prior to entering the study, or acupuncture given specifically for the treatment of hot flashes in the previous 6 months.

Keywords: hot flashes, prostate cancer, acupuncture
study of the safety and efficacy of regn475(sar164877) in patients with pain resulting from thermal injury

Conditions: Thermal Injury Pain

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group, single-dose study of the efficacy of regn475 in patients with pain due to thermal injury.


Eligibility criteria:
inclusion criteria: 1. males or females, ages 18 to 50, who have been hospitalized as a result of thermal injury 2. moderate to severe procedural pain intensity (during wound care) on each of the initial assessment days exclusion criteria: 1. patients with burns caused by chemical exposure or electricity 2. patients with inhalation injury or with evidence of pneumonia, cellulitis, or infection 3. patients with traumatic musculoskeletal injuries (eg, bone fractures or dislocations) or traumatic head or chest injuries 4. significant pre-injury concomitant illness such as, but not limited to, cardiac, renal, neurological, endocrinological, metabolic, psychiatric (including significant anxiety or depression), lymphatic disease, or drug dependence (alcohol or drug abuse), that would adversely affect the patient's management, recovery, or affect mortality or the patient's compliance with protocol assessments. 5. women who are pregnant or nursing
treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous stem cells

Conditions: Corneal Ulcer; Corneal Disease; Corneal Dystrophy

Summary: treatment of patients with inflammatory-dystrophic diseases of the cornea using autologous limbal stem cells (corneal epithelial stem cells) or adipose-derived mesenchymal stem cells

in order to treat inflammatory and dystrophic diseases of the cornea perilimbal injections of cultured autologous stem cells are performed. corneal (limbal) epithelial stem cells (lsc) or mesenchymal stem cells derived from adipose tissue (adsc) are mixed with sodium hyaluronate 1%

Eligibility criteria:
inclusion criteria: * inflammatory-dystrophic diseases of the cornea: 1. epithelial defects of the cornea, ulcerative keratitis of various etiology, resistant to standard methods of treatment 2. dystrophic diseases of the cornea, accompanied by edema 3. burns of the cornea 4. neurotrophic forms of keratitis 5. persistent post-traumatic, postoperative, contusion keratitis and keratopathy exclusion criteria: 1. pregnancy. 2. viral hepatitis b and c, hiv, tubeculosis and other chronic viral and bacterial infections. 3. cancer or leukemia 4. any diseases in the stage of decompensation. 5. mental disorders. 6. anomalies of eye refraction

Keywords: corneal disease
autologous dendritic cell therapy in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: multiple myeloma remains incurable disease in most patients . cellular immunotherapy using dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma. vax-dc/mm is an potent immunotherapeutic agent generated by dendritic cells loaded with the ultraviolet b-irradiated autologous human myeloma cells. the main purpose of this study is to examine the safety and efficacy of vax-dc/mm in patients with relapsed or refractory multiple myeloma.

* to create the vax-dc/mm, myeloma cells will be obtained from the bone marrow of the participants, and leukapheresis will be performed to obtain dendritic cells * not everyone who participants in this study will be receiving the same dose of study vaccine. a small group of patients will be enrolled into the study and given a certain dose. if they tolerate it, the next group of patients enrolled will received a higher dose. * before the first injection of vax-dc, low dose cyclophosphamide will be administered to stimulate immune response. * participants will be received a certain dose of vax-dc weekly four times.

Eligibility criteria:
inclusion criteria: * relapsed or refractory multiple myeloma who received at least one prior therapy including thalidomide, bortezomib, or lenalidomide-containing regimen * subjects with measurable disease defined as at least one of the following serum m-protein ≥ 1.0 g/dl urine m-protein ≥ 400 mg/24hr * eastern cooperative oncology group performance status ≤ 2 * hemoglobin ≥ 8 g/dl (≥ 4.96 mol/l): prior red blood cell transfusion or recombinant human erythropoietin use is allowed. * absolute neutrophil count (anc) ≥ 1.0 x 109/l * aspartate aminotransferase (ast) \< 3 times the upper limit of normal * alanine aminotransferase (alt) \< 3 times the upper limit of normal * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * smoldering or indolent myeloma * uncontrolled or severe cardiovascular disease (cardiac ejection fraction\<0.5, severe conduction disorder ) * sepsis or current active infection * pregnancy or breastfeeding * received other immunotherapy treatment * clinically significant autoimmune disease * serious medical or psychiatric illness likely to interfere with participation in this clinical study
functional magnetic resonance imaging of brain activity in patients with painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: patients with painful diabetic neuropathy (pdn) often combine with anxiety and depression. however, the pathogenesis of pdn is unclear, especially the mechanism associated with central nervous system. the investigators used fraction amplitude of low frequency fluctuation (falff) and regional homogeneity (reho) of resting-state functional magnetic resonance imaging (rs-fmri) to explore the brain activity in patients with pdn in order to study the central mechanism.the investigators evaluated the symptoms, signs and mental conditions of patients with pdn and non-pain neuropathy. the brain blood oxygen level dependent (bold) fmri scan was performed in patients together with some gender and age matched healthy controls. maybe this study can find that patients with pdn have abnormal brain activity, indicating central nervous system may contribute to painful diabetic neuropathy.


Eligibility criteria:
inclusion criteria: * voluntary participation and signing informed consent * 18 to 60 years old with junior high school education or above * meeting the 1999 who type 2 diabetes diagnostic criteria: having symptoms of diabetes (polydipsia, polyphagia, polyuria and unexplained weight loss) plus one of the following 3 items: (1) random blood glucose more than 11.1 mmol/l; (2) fasting blood glucose more than 7 mmol/l; (3) after 2 hours glucose load, the blood sugar more than 11.1 mmol/l * the diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain exclusion criteria: * left-hand writers * neuropathy caused by other causes, such as cervical spondylosis, cerebral infarction, green barre syndrome; severe arteriovenous disease; neurotoxic changes caused by drugs and renal insufficiency * patients with severe cerebral vascular disease * diagnosed mental disorders such as depression, anxiety and alzheimer's disease * patients who can't accept head magnetic resonance imaging, such as those with metal (stents, metal dentures, internal fixation plates, etc.), and claustrophobic space phobias

Keywords: resting state functional mri painful diabetic neuropathy
safety and dose finding trial of bm32 in subjects suffering from grass pollen allergy

Conditions: Grass Pollen Allergy

Summary: the study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine bm32. efficacy will be analyzed by: * skin prick testing * grass pollen inhalation challenge * antibody responses. in addition, the safety of subcutaneous application of bm32 will be evaluated.


Eligibility criteria:
inclusion criteria: * history of seasonal allergic rhinitis from grass pollen * normal electrocardiogram * moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber * positive skin prick test for grass pollen at or within 12 months preceding screening visit * positive rast (class 2 or higher) for timothy grass pollen and to rphl p 1 + rphl p 5 at or within 12 months preceding screening visit exclusion criteria: * pregnant or lactating females * females with childbearing potential not using medically acceptable birth control * structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection * any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function * current or recent participation in another clinical trial * sit for grass pollen allergy in the last two years prior to study * past or present disease, which may affect outcome of the trial, judged by investigator * autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies * suspected hypersensitivity to any ingredients of study medication * use of prohibited medication prior to screening and throughout study * depot corticosteroids (12 weeks) * oral corticosteroids (8 weeks) * inhaled corticosteroids (4 weeks) * allergic symptoms at the time of screening

Keywords: grass pollen allergy immunotherapy recombinant vaccine
fst-201 in the treatment of acute otitis externa

Conditions: Acute Otitis Externa

Summary: the objective of this study is to evaluate the efficacy of fst-201 compared to ciprodex in the treatment of acute otitis externa. this trial is designed to enable filing of a new drug application in support of fst-201 for the indication of acute otitis externa.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of aoe in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1). * be at least 18 years of age at visit 1 (day 1, screening/baseline) of either sex and any race. * provide written informed consent or parental assent. * be willing and able to follow all instructions and attend all study visits exclusion criteria: all subjects must not: * have known sensitivity to any component of the study medications * have a current infection requiring systemic antimicrobial treatment * have used topical or systemic pain meds on the same day as screening/baseline visit 1 and for the duration of the study. * take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to screening/baseline visit 1 * current use of topical or systemic non-steroidal or other anti-inflammatory drugs. * use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as screening/baseline visit 1 * have taken any antibiotics within 3 days prior to visit 1 * have signs and symptoms of aoe for \> 4 weeks at screening/baseline visit 1 * have a non-intact or perforated tympanic membrane in the enrolled ear * have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes * have a clinical diagnosis of malignant otitis externa * have overt fungal aoe * have a viral infection of the pinna or tympanic membrane (i.e herpes zoster) * have congenital abnormalities of the external auditory canal in the enrolled ear(s) * have obstructive bony exostoses in the enrolled ear(s) * have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma) * have malignant tumors of the external auditory canal * have a history of otologic surgery. surgery performed more than 1 year prior to screening/baseline visit 1and limited to the tympanic membrane is allowed * have seborrheic dermatitis of the external auditory canal * have a current or prior history of immunosuppressive disorders * have acute or chronic renal insufficiency, hepatitis or diabetes mellitus * be pregnant, nursing or planning a pregnancy.
optic nerve sheath after extracorporeal circulation

Conditions: Cardiac Disease; Cardiac Valve Disease

Summary: the purpose of this study is to assess the influence of extracorporeal circulation during cardiac surgery on the optic nerve sheath diameter (onsd) after the surgery.

onsd will be measured before and 1 hour after the surgery and in the morning of day 1 after the surgery. fluid balance and lactate will be measured too. ponv will be assessed. patients will be evaluated with moca test on the day before surgery and on the day 3 after the surgery for cognitive disfunction.

Eligibility criteria:
inclusion criteria: * heart surgery with use of cardiopulmonary bypass exclusion criteria: * pregnancy and lactation * neurologic disorders * hyperthyroidism * optic nerve disorders

Keywords: extracorporeal circulation otpic nerve sheath diameter postoperative cognitive disfunction postoperative nausea and vomiting
effect of four exercises on the inter-recti distance in women

Conditions: Diastasis, Muscle

Summary: diastasis rectus abdominis (dra) is defined as an excessive separation between the two abdominal rectus muscles. it is generally quantified by the inter-recti distance. in postpartum women, the prevalence of diastasis is 60% six weeks after delivery. the increase in the inter-recti distance has been associated with a decrease in strength and endurance of the trunk flexors and rotators (p \< 0.05). exercise during pregnancy has been shown to be helpful in the treatment of dra. nevertheless, there is still not strong evidence to establish what kind of exercise should be recommended during pregnancy and in postpartum. the aim of this study is to compare the morphological and functional changes of the linea alba during four exercises. inter-recti distance, linea alba thickness and distortion index will be measured at rest, as well as during 4 exercises (draw in maneuver, crunch, pelvic floor muscle contraction and a "de gasquet" exercise). subgroup analysis will be performed to determine if the presence or absence of an abdominal diastasis has an influence on these outcomes. a cross-sectional pilot study will be carried out. the main outcome measure will the inter-recti distance. secondary outcomes will be the thickness of linea alba and distortion index.


Eligibility criteria:
inclusion criteria: * adults * parous * women * accepting to participe in the research exclusion criteria: * under curatorship * persons deprived of their liberty by judicial or administrative decision * having intellectual limitations that may limit the understanding of questionnaires or exercises * with limitations in understanding the french language * pregnant women * history of pelvic / spine fractures * history of pelvic surgery * history of spinal surgery * history of abdominal surgery * history of lower limbs weakness, changes in osteotendinous reflexes or loss of sensitivity

Keywords: transversus abdominis, diastasis rectus abdominis, exercise, pelvic floor muscles
effects of nutritional counseling on nutritional status and quality of life of head and neck cancer patients

Conditions: Head and Neck Neoplasms

Summary: this study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy.half participants will receive intensive nutritional counseling while the other half will receive standard care.

considering that head and neck cancer patients usually present reduced food intake with consequent involuntary weight loss and significant worsening of quality of life, this study investigates the effects of nutritional counseling versus standard nutritional care on nutritional status and quality of life in patients with head and neck cancer submitted to radiotherapy. half participants (45) will receive intensive nutritional counseling, that is, once they are admitted to the study and once a week during radiotherapy, following the protocol of nutritional care to cancer patients in radiotherapy proposed by the american dietetic association (ada). the other half (45) will receive standard care, that is, nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist (when there is a demand, usually 1 to 2 times during oncologic treatment).

Eligibility criteria:
inclusion criteria: * patients with head and neck cancer (oral cavity, oropharynx, hypopharynx and larynx); both sexes; aged 18 years and over, submitted to radiotherapy after chemotherapy or radiotherapy as a first-choice treatment or as adjuvant treatment (post-surgical). exclusion criteria: * patients using parenteral nutrition; without cognitive ability to understand the concepts of the questionnaires; in palliative radiotherapy.