Kornimate/medical-research-clean huggingface dataset:
eplerenone for the treatment of chronic central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: the aim of the study is to determine the efficacy and safety in treating patients with chronic central serous chorioretinopathy with the drug eplerenone.

* the goal of the study is to examine the short-term effects and safety of eplerenone, a systemic anti-aldosterone medication, in a group of patients with central serous chorioretinopathy (cscr). * there is currently no standard treatment or therapy for chronic cscr, a potentially debilitating eye disease. * there is evidence that high blood serum corticosteroid levels can cause or worsen cscr * eplerenone, a mineralocorticoid receptor antagonist, has been shown to be of visual and anatomic benefit in a small series of 4 patients with chronic cscr, suggesting that decreasing mineralocorticoid action in the eye may improve signs and symptoms of cscr * the study's aim is to evaluate a standardized dose of eplerenone in a controlled prospective fashion for chronic cscr. * the study consists of taking a standard dose of eplerenone, 25mg once daily for a week, followed by 50mg once daily, for a total of 3 months * patients will be monitored for efficacy and side effects from the beginning of treatment and for 6 months

Eligibility criteria:
inclusion criteria: * chronic central serous chorioretinopathy (cscr): previous diagnosis of cscr, persistent subretinal fluid on oct for more than 4 months after initial presentation to the eye clinic exclusion criteria: * other retinal disease * choroidal neovascularization * diabetes * a history of uveitis * ocular surgery in the prior 3 months * allergy to fluorescein or indocyanine green * pregnancy, lactation or female patients in fertility age not treated with contraceptive pills * creatinine clearance \< 50 ml/min * hyperkalemia \> 5 mmol/l * patients treated with drugs deactivated by cytochrome p450 3a4 (cyp3a4) * serum creatinine \> 2 mg/dl in men or \> 1.8 mg/dl in women * treatment with potassium sparing agents or potassium * treatment with angiotensin converting enzyme (ace)/angiotensin ii receptor blocker (arb) inhibitors
a study to evaluate high protein supplementation in hiv-positive patients with stable weight loss

Conditions: HIV Infections; HIV Wasting Syndrome

Summary: the purpose of this study is to determine whether a high-quality protein food supplement will help hiv-positive patients maintain, and possibly gain, muscle mass. many hiv-positive patients lose weight that they are then unable to regain. this may be because patients are not eating enough protein or are not eating the right kinds of protein. the protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to hiv infection. this study gives patients high-quality protein food supplements to help them maintain and/or gain weight.

in many hiv-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by hiv infection. to achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein. two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at weeks 6 and 12. plasma cysteine, glutathione, c-reactive protein, and prealbumin, along with urine il-6, stnfrii, and il-1ra, are assessed at baseline and at week 12.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * are at least 18 years old. * have an hiv level less than 5,000 copies/ml within 30 days of study entry. * have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment. * are expected to live for at least 6 months. * are usually able to eat enough to maintain your present weight. * are able to complete a 3-day food diary. exclusion criteria you will not be eligible for this study if you: * have gained a significant amount of weight in the past 2 months. * have any opportunistic (hiv-associated) infections. * are unable to eat enough food for any reason, or are on tube feeding. * have nausea, diarrhea, or vomiting in the 14 days prior to study entry. * are being treated for diabetes. * are receiving chemotherapy or radiation therapy to treat cancer. * are pregnant or breast-feeding. * are allergic to milk or mangoes. * have an implanted defibrillator.

Keywords: dietary proteins hiv wasting syndrome
efficacy, effect on gametocytes and tolerability of the addition of artesunate to amodiaquine in colombia

Conditions: Malaria,Falciparum; Malaria; Antimalarials

Summary: the primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated p. falciparum malaria, in a low transmission area in colombia. the benefit will be assessed in terms of: * efficacy * tolerability * time of fever clearance * time of parasite clearance * proportion of gametocyte carriers


Eligibility criteria:
inclusion criteria: 1. pure p. falciparum infection 2. parasitaemia \>500 and \ 250 asexual parasites/μl) 3. age between 1 and 65 years old 4. availability to return for follow-up exclusion criteria: 1. pregnancy 2. history of allergy to the study drugs 3. history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week 4. have a medical history of untreated hypertension or chronic heart, kidney or liver disease 5. present any danger signs of severe malaria.
efficacy and safety study of elagolix versus placebo or leuprorelin acetate in endometriosis

Conditions: Endometriosis

Summary: this study is designed to evaluate the safety and beneficial effects of elagolix (nbi-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.

the study followed a parallel-group design in which participants were randomized (1:1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (q.d.); 250 mg elagolix q.d.; placebo; or leuprorelin acetate depot injection 3.75 mg (monthly). blinding was achieved using a double-dummy design. following 12 weeks of dosing, participants continued in the study for an additional 12 weeks; participants randomized to elagolix continued to receive their assigned dose and participants randomized to placebo or leuprorelin acetate were re-randomized to receive one of the two doses of elagolix (150 mg q.d. or 250 mg q.d.) for 12 weeks in a double-blind fashion. six weeks after the last dose of the study drug at the end of week 24, a follow-up visit was performed (end of week 30). there was no pre-specified primary efficacy end point as there was no single key efficacy outcome measure in this exploratory phase 2 study. for purposes of results reported here, change from baseline in the monthly mean numerical rating score (nrs) for endometriosis pain is designated as the primary outcome measure.

Eligibility criteria:
inclusion criteria * female, aged 18 to 45 years, inclusive * have moderate to severe pelvic pain due to endometriosis * have been surgically (laparoscopy) diagnosed with endometriosis within the last 5 years and have recurrent or persistent endometriosis symptoms * have regular menstrual cycle (23-33 day) * agree to use two forms of non-hormonal contraception during the study exclusion criteria: * received a gonadotropin-releasing hormone (gnrh) agonist, gnrh antagonist, danazol, or have received any of these agents within 6 months of the start of screening. * received subcutaneous medroxyprogesterone acetate (dmpa-sc) or intramuscular (i.m.) medroxyprogesterone acetate (dmpa-im), or have received either of these agents within 3 months of the start of screening. * are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month * have had surgery for endometriosis within the last month * are using systemic steroids on a chronic or regular basis within 3 months * have uterine fibroids or other pelvic lesions ≥ 3 cm in diameter * have had a hysterectomy or oophorectomy * have pelvic pain that is not caused by endometriosis * have unstable medical condition or chronic disease * have been pregnant within the last 6 months and is currently breast feeding

Keywords: bone mineral density,endometriosis,pelvic pain
hybrid immunotherapy for hemophagocytic lymphohistiocytosis

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: despite good progress during the last decade, hemophagocytic lymphohistiocytosis (hlh) remains difficult to treat. two different treatment regimens have been used successfully. the first one, a treatment regimen based on two drugs called etoposide and dexamethasone, has been used worldwide. the second regimen, based on two drugs called anti-thymocyte globulin (atg) and prednisone, has been used mostly at one hospital in paris, for over 15 years. with either regimen, about three quarters of treated children survive the most difficult time, the first two months after diagnosis. these two different regimens appear to work somewhat differently, and we suspect that combining them may give better results than either regimen alone. we are conducting this clinical trial to test the combination of atg, dexamethasone, and etoposide for the treatment of hlh. the purpose of this research study is to find out what effects (good and bad) this drug combination has on you and your hlh.

hemophagocytic lymphohistiocytosis (hlh) is a rare immunological disorder first recognized almost 70 years ago.(1) genetic and animal studies have indicated that the familial form of hlh is clearly due to a deficiency of cytotoxic killing. patients with hlh present with a potentially fatal syndrome of 'hyperimmunity.' these patients have severe inflammation, associated with cytopenias and variably severe bone marrow, liver, or cns damage. tissue damage and mortality appear to be due to hypercytokinemia related to persistent immune hyperactivation. an animal model of hlh and correlative human studies all suggest that excessive and abnormal activation of t cells drives the pathophysiology of this disorder, and that suppressing this excessive activation is critical for successful therapy of hlh. it is believed a combination of the two proven induction regimens for hemophagocytic lymphohistiocytosis (hlh) (anti-thymocyte globulin (atg)- and etoposide-based) will result in response rates and overall survival rates at eight weeks which are comparable or better than the current standard of care (induction therapy per the hlh-94 protocol).

Eligibility criteria:
inclusion criteria: * diagnosis of hemophagocytic lymphohistiocytosis * patients \<18 years of age * the patient must have active disease at the time of enrollment * patient's legal guardians must sign an institutional review board approved consent form indicating their awareness of the investigational nature and the risks of this study. * eligible subjects must be enrolled with the protocol coordinating center exclusion criteria: * recent treatment, within 3 months, with another therapeutic regimen for hlh * known active malignancy * known rheumatologic diagnosis which may be the underlying cause of hlh * pregnancy (as determined by serum or urine test) or active breast feeding * failure to provide signed informed consent

Keywords: hemophagocytic lymphohistiocytosis hybrid immunotherapy dexamethasone etoposide atg,rabbit
post approval study of the eversense® continuous glucose monitoring

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: a post approval study to evaluate the long-term safety and effectiveness of the eversense® continuous glucose monitoring (cgm) system over repeat insertion and removal cycles and to demonstrate the long-term safety of the eversense® cgm system

the purpose of this post-approval study (pas) is to provide long-term safety and effectiveness of the eversense cgm system (pma application p160048) in the post-market setting. in the premarket setting, the precise ii and precision studies demonstrated safety and accuracy of the cgm system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days. the promise study demonstrated safety and accuracy of the cgm system up to 180 days. this pas study will provide safety and effectiveness data up to 27 months of repeated use.

Eligibility criteria:
inclusion criteria: 1. subject has diabetes 2. subject is greater than 18 years of age exclusion criteria: 1. subject is critically ill or hospitalized 2. subject has a known contraindication to dexamethasone or dexamethasone acetate 3. subjects requiring intravenous mannitol or mannitol irrigation solutions 4. female subjects who are pregnant, planning on becoming pregnant or nursing 5. subjects on hybrid closed loop systems or closed loop systems 6. subjects on other cgm systems
myopia preventing with distance-image screen

Conditions: Myopia, Progressive

Summary: this study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.

this study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. it was a prospective study. the investigators would like to recruit 100 volunteers, aged 6 years 16 in beijing. all the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. the changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.

Eligibility criteria:
inclusion criteria: * (1) must be 6\~12 years old; * (2) must be best corrected visual acuity \< logmar: 0.1; * (3) spherical equivalence (se) must be -1.00\~ + 6.00 diopter (d), * (4) spherical equivalence (se) must have changed \> 1.25 diopter (d) in the recent 2 years; * (5) must be astigmatism \<1.75 diopter (d); * (6) must be anisometropia \<1.75 diopter(d). exclusion criteria: * (1) strabismus disease; * (2) amblyopia disease; * (3) cataract disease; * (4) glaucoma disease; * (5) severe dry eye disease; * (6) cannot use distance-image screen for 12 month; * (7) other severe diseases that would effect the use of distance-image screen.

Keywords: myopia; children
optimizing the influenza clinical decision support tool

Conditions: Clinical Decision Support

Summary: the proposed study aims to examine several iterations of the influenza best practice alert at nyu langone health. the goal is to increase ordering of the influenza vaccine through the alert.


Eligibility criteria:
inclusion criteria: * all nyu langone health inpatients eligible for the influenza clinical decision support tool exclusion criteria: * n/a
paired-ring mitral annuloplasty ring sizing device

Conditions: Heart Valve Diseases

Summary: the purpose of this study is to evaluate a novel paired-ring mitral annuloplasty sizing system in humans.

this is a pilot feasibility study of an investigational device. the proposed device is designed to be used as a temporary, disposable tool that will guide final ring size selection during mitral valve repair surgery. this device enables the direct measurement of the mitral valve opening. currently, sizing tools for mitral annuloplasty ring implantation has provide only a rough estimate. the field of cardiac surgery is in need of a precise technique to accomplish the important task of correctly selecting an annuloplasty ring for implantation.

Eligibility criteria:
inclusion criteria: 1. all patients scheduled for mitral repair surgery 2. age 18 years or older exclusion criteria: 1. adults unable to consent, 2. pregnant women and prisoners. 3. emergency operations and those patients in whom mitral repair is not performed in a meaningful way, requiring mitral replacement instead, will be excluded. 4. presence of acute endocarditis infection during the initial screening process

Keywords: annuloplasty ring sizing methods
defining optimum cup orientation for hip replacements taking into account the individual's anatomy and movement patterns

Conditions: Hip Arthritis; Hip Osteoarthritis

Summary: the purpose of this study is to investigate and determine the optimal zone for implanting the cup component (the ball that sits in the joint socket) in a total hip replacement. enrolled participants will have a series of x-rays analyzed before surgery to identify their individual optimal zone or cup orientation. this information will be provided to the operating surgeon, who may use this information to influence the placement of the cup implant. follow-up x-rays taken after surgery will determine if the cup is within the suggested optimal zone. questionnaires will be completed before and after surgery, and data on complications or issues with the surgery (including incidents of dislocation) will be collected after surgery.


Eligibility criteria:
inclusion criteria: * signed up for primary total hip arthroplasty procedures at the general campus at the ottawa hospital. exclusion criteria: * unwilling or unable to complete study requirements (either x-rays or questionnaires) * unwilling or unable to sign the informed consent form

Keywords: hip replacement hip arthroplasty arthritis osteoarthritis hip dislocation
study evaluating safety and tolerability of inotuzumab ozogamicin (cmc-544) in japanese patients with b-cell non-hodgkin's lymphoma (nhl)

Conditions: Lymphoma, B-Cell

Summary: to assess the tolerability and the initial safety profile of inotuzumab ozogamicin (cmc-544) in patients with b-cell non-hodgkin's lymphoma (nhl).


Eligibility criteria:
inclusion criteria: * cd22-positive, b-cell nhl which has progressed after 1 or 2 prior therapies. * patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma. * eastern cooperative oncology group (ecog) performance status: 0/ 1. exclusion criteria: * patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article. * patients must not have received bilateral pelvic irradiation. * patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.

Keywords: b-cell non-hodgkin's lymphoma nhl
condol01: evaluation on the experience of bereavement, of a medical consultation, proposed by a letter of condolence to the patients' relatives versus standard practice after the death of the patient

Conditions: Caregivers

Summary: the aim of this randomized multicenter study is to evaluate the impact in offering the condolence letter to the family caregivers (indicated as the reliable person by the patient himself at each hospitalization) and a bereavement consultation with the reference physician.

the hypothesis is that offering the opportunity to clarify questions about the patients' terminal care will influence positively the grieving process. in particular, the study team hypothesized that psychological morbidity will be reduced (main objective) as well as some aspects of qol (secondary objective). it is also assumed that the situations of conflict (solicitations for medical records, number of legal procedures) will be reduced.

Eligibility criteria:
inclusion criteria: * patient died in the institution * patient for which the reliable person has been identified * acceptation of the reference physician to send a letter of condolence with the proposed consultation exclusion criteria: * the physician already met with the caregiver after the patient's death
a more engaging visual field test to increase use and reliability in pediatrics

Conditions: Glaucoma, Suspect; Optic Nerve Hypoplasia and Abnormalities of the Central Nervous System; Congenital Coloboma of the Optic Nerve; Optic Nerve Head Pits, Bilateral Congenital

Summary: the majority of young children do not think that visual field (vf) testing of peripheral vision is similar to a game; therefore, it is not surprising that they have difficulty maintaining attention during vf testing and thus the test reliability suffers as a consequence. poor vf reliability has been a longstanding, major issue since it leads to an increased number of tests and/or longer duration of time needed to determine when there are true vision losses. providers are less likely to obtain vf tests in children since the results are of doubtful value and challenging to interpret when they are inconsistent. effectively this means that children with untreated, slowly progressive eye diseases may go undiagnosed and incur greater visual losses. the investigators aim to create a prototype device that the investigators hypothesize will make vf testing more engaging for young children, thus increasing their attention and consistency of their responses to the test stimuli, which in turn should improve vf reliability. the components include a microdisplay video screen (1.5" diameter) as the fixation target (instead of the standard led light) displaying video clips of popular cartoon characters, and audio clips of impersonated cartoon character voices presented by the test operator to provide instructional feedback based on the child's performance during testing. improved vf reliability from the investigators intervention would translate to improved diagnosis and care for young childrens' peripheral vision loss through widespread implementation of the investigators innovative, affordable and readily adoptable system at eye care providers' offices.


Eligibility criteria:
inclusion criteria: * ages 5-8 * seen previously in the clinics at nova southeastern university's the eye care institute with a diagnosis for glaucoma suspect or optic nerve abnormalities * able and willing to complete vf testing at 2 study visits about a week apart * provide informed consent exclusion criteria: * history of having previously completed a vf test using humphrey static perimetry * inability to understand study or communicate responses (cognitive impairment) * unable to understand, read and speak english fluently

Keywords: humphrey visual fields perimetry pediatrics