Kornimate/medical-research-clean huggingface dataset:
reflex study (endotak reliance g evaluation of handling and electrical performance

Conditions: Arrhythmia

Summary: the reflex study will evaluate if endotak reliance g defibrillation leads with gore eptfe-covered coils are as good as or better than other comparative commercially available defibrillation leads with respect to electrical performance and termination efficacy in spontaneous tachyarrhythmic episodes.


Eligibility criteria:
inclusion criteria: * patients who meet current icd or crt-d indications * patients who are going to be implanted with one of the aforementioned icd or crt-d devices * patients who are going to be implanted with active-fixation, dual-coil, endocardial defibrillation leads with compatible connectors (i.e., endotak reliance g or study-comparative icd leads) * patients who sign and date a patient informed consent form prior to device implant * patients who remain in the clinical care of the enrolling physician in approved centers * patients who are at least 18 years old exclusion criteria: * patients who have a preexisting transvenous lead system that is not completely explanted * patients who are hypersensitive to a single dose of approximately 1.0 mg of dexamethasone acetate * patients who are expected to receive a heart transplant during the duration of the study * patients whose estimated life expectancy is less than 12 months due to other medical conditions * patients who currently have or who are likely to receive a tricuspid valve prosthesis * patients who are likely to have an open-chest surgery in the next three months * patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the reflex study. * patients who are mentally incompetent and cannot sign a patient informed consent form or comply with the study * patients who are pregnant
icg-guided photodynamic therapy for treatment of retinal capillary abnormalities: a pilot study

Conditions: Retinal Vascular Disorders

Summary: the purpose of this research is to use an approved drug(visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.

the study will include 30 patients who were diagnosed with retinal capillary abnormalities and include 2 follow-up visits at 6 and 12 months post-procedure to determine if the treatment has been effective in treating their disorder. it is anticipated that approximately half of the patients will require an additional treatment. patients will be enrolled from our patient population and be 50 years of age and older, male or female. pregnant women or women of normal child bearing age will be excluded since there are no adequate and well-controlled studies on the use of photodynamic therapy in pregnant women. any retinal vascular abnormality that has a standard of care method of treatment will also be excluded from the study population.

Eligibility criteria:
inclusion criteria:• individuals that are 50 years of age and older. * patients with retinal capilary abnormalities/vascular diseases such as macular telangiectasia type i and type ii, retinal arteriolar macroanurysms, and retinal angiomous proliferation (rap). * patients with diabetic retinopathy and branch retinal vein occlusions * other patients who are non-responders to approved treatment methods exclusion criteria: * patients whose diseases have approved methods of treatment. * pregnant women or women of normal child bearing age.
home diagnosis and treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is a common and underrecognised condition. the diagnosis of osa is typically made after an in-lab polysomnography (psg) which requires an overnight stay in a sleep laboratory. many sleep laboratories have long waiting lists for psg. there are a number of portable devices which may be useful in home diagnosis of osa, however there is limited data on outcomes of osa diagnosed and treated at home. in this study we propose to compare diagnostic accuracy of a home monitoring device with a psg and outcomes of osa therapy when implemented at home vs in the sleep laboratory.

we will randomise patients suspected to have osa to either home evaluation and treatment (using a portable monitor and auto-cpap) or in-lab evaluation with a psg and manually-titrated cpap. we will obtain sleep, sleepiness and quality of life questionnaires, vigilance testing and blood pressure at baseline and after 1, 2, 4 and 12 weeks of therapy. we will also assess and compare compliance with cpap therapy in each arm of the study.

Eligibility criteria:
inclusion criteria: * adult ( age \> 18) * suspected osa * no coexisting heart or lung disease * not in a safety-sensitive occupation exclusion criteria: -

Keywords: sleep apnea, home monitoring, cpap
acute pain study following bunionectomy

Conditions: Pain

Summary: the primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

the bunionectomy was performed under regional anesthesia and propofol sedation. perioperative anesthesia was standardized for all participants. upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol. after an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (vas) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Eligibility criteria:
inclusion criteria: subjects who were in general good health, experiencing moderate to severe pain following bunionectomy exclusion criteria: * subjects who underwent base wedge osteotomy and / or long-z hart bunionectomy procedures * drug allergies to hydrocodone, acetaminophen * clinically significant or uncontrolled medical disorders or illness - history of drug or alcohol abuse / addiction
study to evaluate the efficacy and safety of filgotinib in the induction and maintenance of remission in adults with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (uc) in participants who are biologic-naive and biologic-experienced. participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (lte) study (gilead study gs-us-418-3899: nct02914535).


Eligibility criteria:
key inclusion criteria: * males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit * documented diagnosis of uc of at least 6 months and with a minimum disease extent of 15 cm from the anal verge. documentation should include endoscopic and histopathologic evidence of uc. * a surveillance colonoscopy is required at screening in individuals with a history of uc for 8 or more years, if one was not performed in the prior 24 months * moderately to severely active uc * previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (tnfa) antagonists, or vedolizumab key exclusion criteria: * presence of crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon * active tuberculosis (tb) or history of latent tb that has not been treated * use of any concomitant prohibited medications as described in the protocol note: other protocol defined inclusion/exclusion criteria may apply.
treatment of mild hypertension study (tomhs)

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: to compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.

background: dietary sodium reduction has a mild effect on the reduction of hypertension. weight loss, while achievable in the short-run with diet alone, may also have only mild effects on hypertension and is very difficult to maintain with diet and/or behavior modification. alteration of patients' lifestyles to decrease excessive alcohol intake is somewhat controversial. medications, on the other hand, have clear benefits in terms of blood pressure lowering, and in the case of diuretics and beta-blockers, reduction in cardiovascular morbidity and mortality. however, there is concern about their justified use in mild hypertension since each one has side effects, some of which may have long-term implications, such as alteration in serum lipids. newer classes of drugs--calcium antagonists, angiotensin converting enzyme inhibitors, alpha blockers--had not previously been compared long-term with diuretics and beta-blockers. design narrative: tomhs i enrolled 902 men and women to determine the feasibility of a larger trial. participants were randomized in a double-blind manner to one of six treatment groups and within two strata. stratum i was for participants not on antihypertensive drugs and stratum ii for those on antihypertensive drugs at initial screening. there were six treatment arms: placebo, a diuretic (chlorthalidone), a beta-adrenergic blocking agent (acebutolol), an alpha blocker (doxazosin mesylate), a calcium antagonist (amlodipine maleate), and an angiotensin converting enzyme inhibitor (enalapril maleate). all participants received a lifestyle intervention program that included reduction of sodium chloride and alcohol intake as well as weight reduction and increase in physical activity. all participants were followed for at least 48 months, with an average of 54 months. the primary endpoint was lowering of blood pressure. the treatments were also compared for effects on blood chemistries including lipoproteins, echocardiographic left ventricular mass, ventricular ectopic activity and st-t changes of ischemia as measured by ambulatory ecg monitoring, side effects, and quality of life. randomization took place between october 1986 and march 1988. active follow-up ended in march-april 1992. data analysis ended in may 1994.

Eligibility criteria:
men and women, ages 45 to 69, with mild hypertension (diastolic blood pressure of 90-99 mm hg at two of three visits for untreated individuals. patients who received drug therapy must have had a dbp less than 95 mm hg two to four weeks after drug.
a non-interventional pilot study to explore the role of gut flora in lyme disease

Conditions: Lyme Disease; Lyme Disease, Chronic

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding lyme disease

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding lyme disease

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age (interest is given to children to compare with mothers) 3. diagnosis of lyme disease exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
reconstruction of the orbit with a bioresorbable polycaprolactone implant

Conditions: Orbital Trauma; Orbital Fractures

Summary: patients with orbital injuries are entered into the trial. age: 20 - 70. after obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. ct scan of the orbits are performed preop, 6 months \& 12 months. end point is the 12 month follow-up appointment. visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.

patients with orbital injuries are entered into the trial. age: 20 - 70. after obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established practice) or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone. patients are followuped at 1 week, 1 month, 3 months, 6 months \& 12 months. ct scan of the orbits are performed preop, 6 months \& 12 months. end point is the 12 month follow-up appointment. visual acuity, range of motion, enophthalmos \& diplopia are assessed in follow-up.

Eligibility criteria:
inclusion criteria: * age: 20 - 70 years facial trauma with orbital fractures exclusion criteria: * no other coexistent conditions eg. diabetes, heart disease, etc

Keywords: orbit orbital trauma fractures facial
vaspin levels compared with serum insulin and blood glucose levels in neonates

Conditions: Insulin Sensitivity

Summary: the aim of this study was to investigate circulating concentrations of vaspin in fetal and neonatal samples from sga, aga and lga with the respective insulin concentrations. serum vaspin concentrations were determined by enzyme immunoassay in 22 sga and 30 lga and 30 aga singleton full-term fetuses and neonates on cord blood and postnatal day 5.


Eligibility criteria:
inclusion criteria: * full term healthy infant exclusion criteria: * sepsis * congenital anomaly * sick infant

Keywords: vaspin lga sga insulin blood glucose
effect of reversed tracking method for identification of ebsln in thyroid surgery

Conditions: Thyroid Cancer; Recurrent Laryngeal Nerve Injuries

Summary: the feasibility and effectiveness of reversed tracking method for the identification and protection of extralaryngeal nerve branches in thyroid surgery were analyzed. evidence-based medical evidence was used to evaluate the importance of ebsln recognition and protection in thyroid surgery.

the incidence of thyroid cancer in the world is growing rapidly. the current incidence of thyroid cancer in china is about 4.2/100,000, ranking the fourth in the incidence of female malignant tumors. surgical treatment is the first and most important treatment for thyroid cancer. according to the existing literature, the injury rate of ebsln in thyroid surgery can be as high as 58%. the quality of sound changes caused by ebsln injury affects the quality of life of patients after surgery, and even affects the work and career of patients. therefore, seeking better ebsln protection the method has great social and economic benefits.

Eligibility criteria:
inclusion criteria： 1. thyroid papillary cancer patients 2. thyroid adenoma patients 3. tumor diameter less than 4cm 4. patients who require only unilateral thyroid surgery as required by the guidelines exclusion criteria: 1. the upper pole tumor invades the anterior dorsum and may accumulate the area of the superior laryngeal nerve; 2. patients who have previously performed head and neck surgery; 3. preoperative laryngoscopy and sound assessment abnormalities or previous vocal cord surgery history; 4. if there is a language or hearing impairment, the follow-up assessment cannot be completed; 5. the assessment failure of nerve function due to the technical deficiency of the ionm equipment elimination criteria: 1. patients with recurrent laryngeal nerve palsy after surgery affect the evaluation of the laryngeal nerve. 2. the patient is asked to withdraw from the follow-up assessment midway.

Keywords: external branches of superior laryngeal nerve thyroidectomy thyroid cancer
a study investigating oral semaglutide in people with open-angle glaucoma

Conditions: Primary Open Angle Glaucoma (POAG); Open-Angle Glaucoma; Glaucoma

Summary: the aim of this clinical trial is to investigate whether oral semaglutide can be used to treat open-angle glaucoma. the main question it aims to answer is: does oral semaglutide safely improve inner retinal function in patients with open-angle glaucoma as measured by the photopic negative response of the electroretinogram. researchers will compare oral semaglutide to a placebo (a look-alike substance that contains no drug). participants will: * take semaglutide or a placebo every day for 6 months. * visit the clinic 5 times in total for tests and interviews: at baseline (the first day they are included in the study), after 1 month, after 2 months, after 3 months, and after 6 months (the last day they are included in the study).


Eligibility criteria:
inclusion criteria: * ability to read and speak danish * 45 years or older at the time of inclusion * visual acuity equal to or above 0.5 in the study eye * diagnosis of poag with md ≤ 16 db with repeatable and reliable (false positive less than 15 %) vf loss measured by standard automated perimetry on at least one eye * receiving iop-lowering glaucoma treatment * nerve fiber layer defects identified by oct exclusion criteria: * diabetes or renal impairment * medical history of significant eye disease (including ocular trauma) other than glaucoma * ocular inflammation/infection within three months from inclusion * intraocular surgery 3 months before inclusion * smoker at the time of inclusion * pregnant or breast-feeding * females of childbearing potential who are not using adequate contraceptive, which includes the following: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable; intrauterine device (iud); intrauterine hormone-releasing system (ius); bilateral tubal occlusion; vasectomised partner; sexual abstinence * subjects allergic to drug ingredients administered during the trial * subjects with untreated severe systemic disease or malignancies * previous history of pancreatitis * bmi \< 18.5 * subjects receiving treatment with: dipeptidyl peptidase-4 inhibitors; other glp-1ras; insulin; insulin analogues; sulfonylurea; systemic corticosteroids; immunosuppressants

Keywords: glaucoma semaglutide rybelsus primary open angle glaucoma glp-1ra photopic negative response glp-1
pharmacokinetics, safety and tolerability of zavesca (miglustat) in patients with infantile onset gangliosidosis: single and steady state oral doses

Conditions: GM2 Gangliosidoses; Tay-Sachs; Sandhoff Disease

Summary: we want to see if zavesca (or miglustat) is safe and can be tolerated by patients with acute infantile onset gm2 gangliosidosis - classical tay-sachs and infantile onset sandhoff disease. we know that miglustat inhibits the formation of gm2 ganglioside, the compound that is stored in the brains of children with tay-sachs and sandhoff disease. since it inhibits the synthesis of ganglioside, miglustat may be able to reduce or delay the onset of clinical symptoms.

specific aims the primary objective of the study is to investigate the pharmacokinetics of zavesca® (miglustat, ogt918), when given as a single dose and at steady state, in infantile patients with gm2 gangliosidosis. the secondary objectives are to evaluate the tolerability and safety of single and multiple doses of miglustat and to monitor disease progression using physical and developmental assessments and disease-specific biomarkers.

Eligibility criteria:
inclusion criteria 1. diagnosis of gm2 gangliosidosis, confirmed by demonstration of profound deficiency of -hexosaminidase a or a \& b in peripheral blood leukocytes or in cultured skin fibroblasts, within the previous 1 year in non-bone marrow transplant recipients who are \< 2 years of age, or prior to stem cell transplant in stably engrafted transplant patients who are \< 5 years of age. 2. onset of characteristic clinical symptoms of the disease before the age of 9 months. 3. normal renal and hepatic function. 4. written informed consent from parent or legal guardian. exclusion criteria 1. patients who are unable to comply with the study procedures of this protocol, including the refusal to swallow the food used to mask the taste of the study drug and whose parents are unwilling to administer the drug through a nasogastric or gastrostomy tube. 2. patients receiving other investigational agents within 3 months of study initiation. 3. patients who are anemic (hemoglobin \< 11 g/dl, and/or hematocrit \< 34%) 4. patients who have a history of significant gastrointestinal disorders, including clinically significant diarrhea (\>3 liquid stools per day for \> 7 days), without definable cause within 3 months of baseline visit. 5. patients with a high probability of dying during the 6-month assessment period of the study. 6. patients who in the opinion of the investigator (for whatever reason) are thought to be unsuitable for the study.
continuous positive airway pressure (cpap) for preventing respiratory failure after laparoscopic radical prostatectomy

Conditions: Continuous Positive Airway Pressure [E02.041.625.790.259]; Prostatectomy [E04.950.774.860.625]; Laparoscopy [E01.370.388.250.520]; Pneumoperitoneum [C06.844.670]

Summary: aim of this study is verify if postoperative cpap after laparoscopic prostatectomy may reduce the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (pao2\<60 mmhg) and/or reduction of forced expiratory volume in 1 second (fev1) beyond 70% of basal value.

laparoscopic radical prostatectomy (lrp) is a wide used, well tolerated procedure. however, the general anesthesia, the need for pneumoperitoneum and trendelenburg position may have detrimental effects on both pulmonary volumes and mechanics, and they may increase the risk of postoperative respiratory failure (porf). continuous positive airway pressure (cpap) improves oxygenation and reduces the rate of re-intubation in the presence of porf. the aim of our study is to investigate postoperative respiratory function and the likely benefits of the use of cpap, compared with venturi mask in terms of prevention of post-operative hypoxaemia and worsening of lung spirometry. cpap is delivered with "castar" helmet by starmed.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective laparoscopic prostatectomy * american society of anesthesiologists status i-ii exclusion criteria: * cardiac functional status new york heart association (nyha) \>ii * chronic obstructive pulmonary disease (copd) gold class \>2