Kornimate/medical-research-clean huggingface dataset:
a safety assessment of the izephyr hood for niv in covid-19 patients

Conditions: Aerosol Disease; Covid19; Noninvasive Ventilation

Summary: this study is a safety assessment of the izephyr hood a novel aerosol removal device in patients receiving non invasive ventilation for covid-19.

demonstrate that safety and suitability of the izephyr hood in patients receiving non-invasive ventilation (niv) or high flow oxygen therapy (hfot). determine the user acceptability of the izephyr hood in patients receiving niv and hfot. determine the reduction in aerosol spread of covid-19 viral particles when using the zephyr hood in patients using non-invasive ventilation or high flow oxygen.

Eligibility criteria:
inclusion criteria: adult covid-19 negative patients who are requiring non-invasive ventilation (phase ii) adult covid-19 positive patients who are requiring non-invasive ventilation (phase iii) exclusion criteria: patients under the age of 18 years or those lacking capacity
eeg biomarker study for participants in the neurolief "mood" trial

Conditions: Depression

Summary: this study will collect eeg data at 3 time points from up to 40 adults who are enrolled in a double clinical trial investigating a device that delivers noninvasive, self-administered external combined occipital and trigeminal neurostimulation (ecot-ns) treatment for major depressive disorder (relivion®dp). baseline (pre-treatment) frontal eeg alpha oscillations (power) will be compared post-stimulation power.

eeg biomarkers may be useful for understanding abnormal brain oscillations associated with major depressive disorder (mdd) and other psychiatric disorders as well as the brain changes that occur when symptoms remit. this study will invite adults with mdd who enroll and are randomized in the neurolief sponsored "mood" study to undergo collection of eeg data at pre-treatment baseline, again after completing the 8-week blinded treatment phase, and, if eligible/appropriate, again after completing an 8-week open-label treatment phase. eeg will be recorded at rest and during a computer task. this eeg "add-on" study is observational in nature, as it will not manipulate the treatment assignment in the mood clinical trial or otherwise impact concurrently ongoing treatments for any condition. researchers collecting and analyzing eeg data will be blinded to treatment assignment when participants are in the double-blinded treatment phase of the mood clinical trial. eeg data will be processed and analyzed to evaluate changes in frontal alpha oscillations associated with 8 weeks of active relivion®dp stimulation.

Eligibility criteria:
inclusion criteria: * meets all criteria for participation in the neurolief-sponsored mood clinical trial (nct04279522) and has been randomized to a treatment group for the double-blind phase. * is willing and able to participate in up to 3 additional research visits for eeg data collections. exclusion criteria: * none
emory latino diabetes education program

Conditions: Diabetes

Summary: latinos with diabetes who are attending the emory latino diabetes education program will be approached about consenting to have clinical measurements collected to assess changes between baseline and monthly follow up sessions. the no-cost educational sessions follow the self-care behavior curriculum of the american association of diabetes educators (aade).

latinos represent the largest minority group in the united states with a population of 35 million or 12.5%. national surveys indicate that the prevalence of type 2 diabetes is 1.9 times higher in latinos than non-whites, and that approximately 24% percent of latinos over the age of 45 years have diabetes. in georgia, latinos make up approximately 6.5% of the population. during 1990 and 2000, the prevalence of diabetes in fulton and dekalb counties, two of the most populated areas in georgia and the atlanta metropolitan area increased by 30%. language and cultural barriers represent the two most important obstacles in educating and improving the care of latino patients with diabetes. less than 5% of physicians, 2% of nurses, and 2.5% of dentists in the us speak spanish. the emory latino diabetes education program has been in existence since december 2005. this program aims to deliver diabetes education in spanish to the underserved latino community in metro atlanta. program participants attend an initial 3 hour diabetes education class in spanish. the class curriculum follows the american association of diabetes educators (aade) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. participants are invited to return to a follow-up session within 6 months. follow-up sessions are held in the late afternoon. these sessions are discussion-based and include an activity such as salsa lessons and cooking demonstrations. diabetes education classes and follow-up sessions are offered at grady memorial hospital (diabetes clinic, international medical center), grady north dekalb clinic (chamblee), and north fulton regional hospital. participants complete a questionnaire assessing behaviors and social and demographic characteristics of the latino community being served. hemoglobin a1c, blood pressure, weight, body mass index (bmi) and waist circumference will be measured at the beginning of each class. this study will analyze and publish data collected from individuals who are attending the educational sessions. additionally, the researchers will collect retrospective data from past participants in the program.

Eligibility criteria:
inclusion criteria: * spanish speaking patients with diabetes exclusion criteria: * under 18 years of age

Keywords: diabetes latino population
italian multicenter database for open conversions after evar

Conditions: Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm Enlargement

Summary: late endovascular abdominal aneurysm repair (evar) complications not amenable to endovascular correction can undergo either late open conversion (loc) or semi-conversion (sc). loc is defined as a total or partial endograft explantation \>30 days after the initial evar. sc is defined as open or laparoscopic surgery for endoleak (el) correction with complete endograft preservation. the aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of loc and sc, and to analyse early and long-term outcomes of these two treatments.


Eligibility criteria:
inclusion criteria: * open or laparoscopic surgery for evar complications, with or without endograft explantation exclusion criteria: * endovascular reinterventions * extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery

Keywords: abdominal aortic aneurysm open surgical conversion endovascular repair evar explantation failed evar
cinacalcet hcl in chronic kidney disease subjects with secondary hyperparathyroidism not receiving dialysis

Conditions: Kidney Disease; Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of cinacalcet compared with placebo in patients with stage 3 and 4 chronic kidney disease (ckd).


Eligibility criteria:
inclusion criteria: chronic kidney disease patients not receiving dialysis with: - an ipth greater than 100 pg/ml \[10.6 pmol/l\] for subjects with stage 3 ckd or greater than or equal to 160 pg/ml \[17.0 pmol/l\] for subjects with stage 4 ckd; - a serum calcium greater than 9.0 mg/dl \[2.25 mmol/l\]; - an estimated gfr less than or equal to 59 ml/min and greater than or equal to 15 ml/min. exclusion criteria: - have an unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgment of the investigator. - experienced a myocardial infarction (mi) within 3 months before day 1. - likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day 1. - received active vitamin d therapy (i.e., 1-hydroxylated metabolites of vitamin d) for less than 30 days before day 1 or required a change in active vitamin d brand or dose level within 30 days before day 1 (for patients prescribed active vitamin d).

Keywords: sensipar® mimpara® cinacalcet calcimimetic chronic kidney disease
study to evaluate safety, pharmacokinetics and pharmacodynamics of chf5074 in healthy young male subjects

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of chf5074 in young healthy male volunteers.


Eligibility criteria:
inclusion criteria: * subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ecg) and standard laboratory tests. exclusion criteria: * medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease. * abnormal results of liver function tests, renal function tests or thyroid tests performed at screening. * significant allergic conditions that require medical treatment * use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration. * use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
bioequivalence study of amoxicillin 400 mg/clavulanic acid 57 mg chewable tablets under fed conditions

Conditions: Healthy

Summary: the objective of this study was to compare the single-dose relative bioavailability of ranbaxy and glaxosmithkline (augmentin®) 400 mg amoxicillin (as the trihydrate) and 57 mg clavulnic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fed conditions

the study was conducted as an open-label, randomized, 2-way crossover study to compare the single-dose relative bioavailability of ranbaxy and glaxosmithkline (augmentin® 40o mg) amoxicillin (as the trihydrate)/57 mg clavulanic acid (as the potassium salt) chewable tablet, following administration of 2 tablet dose under fed conditions a total of 40 subjects, 20 males and 20 females; were enrolled in the study, and 39 subjects, 20 males and 19 females, completed the study.

Eligibility criteria:
inclusion criteria: 1. healthy adult male or female volunteers, 18-55 years of age 2. weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of "desirable weights of adults", metropolitan life insurance company, 1983); 3. medically healthy subjects with clinically normal laboratory profiles; 4. females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods: surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum; iud in place for at least 3 months; barrier methods (condom, diaphragm) with spermicide for at least 14 days pror to the start of the study and .throughout the study; surgical sterilization of the partner (vasectomy for 6 months minimum); hormonal contraceptives for at least 3 months pdor to the start of the study. other birth control methods may be deemed acceptable. postmenopausal women with amenorrhea for at least 2 years will be eligible; 5. voluntarily consent to participate in the study. exclusion criteria: subject candidates must not be enrolled in the study if they meet any of the following criteria: 1. history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic,gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. 2. in addition, history or presence of: alcoholism or drug abuse within the past 2 years; hypersensitivity or idiosyncratic reaction to antibiotics, especially penicillins, cephalosporins and amoxicillin and/or clavulanic acid 3. female subjects who are pregnant or lactating. 4. subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose. 5. subjects who have made a donation (standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 30 days prior to the study. 6. subjects who have made a plasma donation within 7 days prior to the study 7. subjects who have participated in another clinical trial within 30 days prior to the first dose.

Keywords: bioequivalence
smartphone addiction and muscular disorder

Conditions: Myofascial Trigger Point

Summary: background and aim: the use of smartphones, which has reached the level of addiction causes some physical and psychological health problems. the aim was to examine the musculoskeletal disorders of the neck and upper extremities of mobile phone addiction in a population of young adults. methods: the study is a cross sectional research conducted on students of a university in i̇stanbul between december 2018-october 2020. the level of addiction was assessed with the smartphone addiction scale short form (sas-sf). the posture of participants was evaluated by new york posture rating chart (nyprc), mostly usage smartphone posture, forward head and myofascial trigger points were questioned according to simon and travel criteria. mann-whitney u test pearson's chi-squared test were used for analyzing the data.


Eligibility criteria:
inclusion criteria: * used smartphones * volunteered to participate in the study. exclusion criteria: * having any history of trauma at the neck region within the last six months, * taking any treatment for trigger points within the last 3 months * having a history of neck surgery.

Keywords: smartphone mobile phone addiction myofascial trigger point forward head
beta blockers versus variceal band ligation and beta blockers for primary prophylaxis of variceal bleeding

Conditions: Esophageal Varices

Summary: patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). these have an increased risk of bleeding each year. current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). using both therapies at the same time has not been studied. in this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). the efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.


Eligibility criteria:
inclusion criteria: * cirrhosis * medium to large varices exclusion criteria: * contraindications to beta blockers * refusal to give consent * prior history of variceal hemorrhage * creatinine \> 1.5 mg/dl

Keywords: varices band ligation portal hypertension primary prophylaxis cirrhosis beta blockers
clinical use of an absorbable coated suture material in surgery (safil)

Conditions: Gastrointestinal Diseases; Laparotomy; Anastomosis, Surgical; Absorbable, Coated Sutures

Summary: the purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial. the applicability and safety of the strand material used in two suture techniques (2-layer suture technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the operative time consumed for the construction of the 1st anastomosis, the average time of the hospital duration for both patient groups, and the frequency of postoperative complications after discharge, 1 month and a maximum of 3-4 months. the used suture units are counted and the length of sutures determined which will be an indirect measurement of the costs of suture material for the two techniques.


Eligibility criteria:
inclusion criteria: * patients of both sexes, undergoing a gastrointestinal hand made one-layer running (a) or two-layer (b) anastomotic procedure where the use of synthetic absorbable surgical suture material is indicated. * written consent to participate in the study exclusion criteria: * emergency patients that cannot be properly informed about the clinical trial and cannot give their written consent * pregnancy or lactation period * patients suffering from a diffuse purulent peritonitis or generalized diseases, which can have consequences for the healing of the asnastomosis (e.g. ubalanced diabetes, progressed uremia, massive hypoproteinaemia, sever jaundice, generalized intraabdominal tumor metastases, severe tumorous cachexia, severe avitaminosis, chronic liver disease. * patients who are undergoing a therapeutic procedure, which can have consequences for the healing of the anastomosis (e.g. treatment with corticosteroids or cytostatics, local radiation in the operating area) * laparoscopial procedures * patients who are not willing to cooperate and legally incapacitated people

Keywords: gastrointestinal anastomosis multicentre randomized controlled single-blind study synthetic, absorbable, braided and coated suture material laparotomy
a study of bevacizumab with taxane therapy in participants with triple negative breast cancer

Conditions: Breast Cancer

Summary: this open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (her2)-negative (triple-negative) breast cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed triple-negative (estrogen, progesterone, and her-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease * participant who in the investigator's opinion requires combination therapy for their disease * life expectancy of greater than or equal to (\>/=)12 weeks exclusion criteria: * previous chemotherapy for metastatic breast cancer * participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain) * major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment
piggyback sulcoflex toric iol for correcting refractive error following corneal transplantation

Conditions: Refractive Error; Corneal Implantation; Intraocular Lens Implantation

Summary: a prospective study to evaluate the safety and efficacy of a piggyback sulcoflex toric intraocular lens in pseudophakic patients for correcting refractive errors following corneal transplantation


Eligibility criteria:
inclusion criteria: * after corneal transplantation with refractive errors * after cataract removal and intraocular lens implantation exclusion criteria: * other ophthalmologic disorders limiting vision including glaucoma, amd, profound amblyopia

Keywords: sulcoflex toric corneal implantation
to compare "balloon occluded thrombolysis" with "conventional catheter directed thrombolysis" in thrombotically occluded dipss stent in patients of budd- chiari syndrome.

Conditions: Budd-Chiari Syndrome

Summary: dipss has become a widely accepted treatment for complications of portal hypertension. shunt or hepatic vein stenosis are common short and mid term complications of the procedure. when identified early, shunt stenosis or occlusion may be treated before recurrence of the symptoms for which dipss was done at the first place. present day endovascular dipss revision techniques have significantly improved the primary assisted patency rates. the purpose of this study is to understand the newer technique of combined balloon occlusion thrombolysis and intra stent balloon sweeping being practiced at our institute and compare it with the widely used conventional thrombolytic methods.

primary objective: 1. to study the outcome of combined technique of balloon occluded thrombolysis, balloon sweeping and maceration of thrombus in blocked dipss stent and compare it with conventional catheter directed thrombolysis and angioplasty. secondary objective: 2. study dipss stent patency and re-occlusion rates at 1 month followup methodology: study population: patients with budd -chiari syndrome who underwent dipss revision till february 2021 study design: single center retrospective cohort study study period: 1year sample size: all eligible patients according to inclusion and exclusion criteria who underwent tips/dips revision will be included in thestudy. intervention: dipss revision monitoring andassessment: the following parameters to be evaluated over a period at least 1 month after dipss revision and compare with pre revisionvalues clinical parameters: status of ascites urine output recurrence of ugi/lgi bleed laboratory parameters: albi score,lft, kft doppler parameters: mid stent velocity, velocity at hepatic venous end main portal vein velocity direction of flow in intrahepatic portal vein branches stopping rule: not applicable. expected outcome of the project: balloon occluded thrombolytic infusion alongwith intratsent balloon sweeping gives faster and better patency as compared to conventional pharmaco-mechanicalthrombolytic methods

Eligibility criteria:
inclusion criteria: 1. patients of budd- chiari syndrome who underwent dipss revision for blocked stent till february 2021 exclusion criteria: 1. patients who underwent dipss revision more than one time using both the techniques were excluded. 2. failure to cannulate existing shunt.
a study of the natural history of leukocyte chemotactic factor 2 amyloidosis (alect2) disease

Conditions: Amyloidosis; Leukocyte Chemotactic Factor 2 Amyloidosis

Summary: the purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (alect2) disease. in this observational study participants with alect2 disease will be enrolled. participants, who have already reached end-stage renal disease (esrd), will provide retrospective chart review data and biological specimens at baseline only. other participants, in addition to retrospective chart review, will be followed prospectively.

refer to www.studyalect2.com

Eligibility criteria:
inclusion criteria: * males and females, age 18 years or older; * renal biopsy-proven diagnosis of alect2; * for patients with kidney disease that could be due to alect2, a renal biopsy may be obtained to confirm alect2 diagnosis. exclusion criteria: - there are no exclusion criteria for this observational study.