Kornimate/medical-research-clean huggingface dataset:
penile length maintenance post-prostatectomy

Conditions: Prostate Cancer; Penile Diseases

Summary: the objective of the current study is to evaluate the efficacy of a novel, class i (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.

the treatment of prostate cancer results in several known sexual dysfunctions, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (peyronie's disease), and reduced penile length. among the dysfunctions, loss of penile length is often one that results in significant distress and bother to patients. beyond the esthetic concerns, reduced penile length may lead to inability to participate in sexual intercourse, difficulty with future interventions to restore erectile function, and lead to worsened urinary hygiene. penile traction therapy (ptt) is currently the best available treatment to maintain or restore lost penile length due to conditions that reduce length. to date, no studies have evaluated the benefits of using ptt in this clinical setting. the objective of the current study is to evaluate the efficacy of a novel penile traction device (restorex®), created and funded through mayo ventures, in maintaining or restoring reduced penile length. to accomplish the study, a population of men from mayo clinic who have undergone a prostatectomy will be enrolled and randomized to utilize the device for varying amounts of time. outcomes will be assessed at 6 and 9 months post-prostatectomy and results are to be used with the intent to publish in a scientific journal.

Eligibility criteria:
inclusion criteria: * undergoing robotic prostatectomy * seen in the post-prostatectomy rehab clinic exclusion criteria: • urethral complications from prostatectomy at the time of baseline visit
efficacy and safety in chinese patients with immunoglobulin a nephropathy (igan) who have completed study nef-301

Conditions: Primary Immunoglobulin a Nephropathy (IgAN)

Summary: this is a phase 3b, multicenter, open-label extension (ole) study to evaluate the efficacy and safety of nefecon treatment in chinese patients who have completed nef-301 and continue to be treated with a stable dose of renin-angiotensin system (ras) inhibitor therapy (angiotensin-converting enzyme inhibitors (aceis) and/or angiotensin ii type i receptor blockers (arbs).

this is a phase 3b, multicenter, open-label extension (ole) study to evaluate the efficacy and safety of nefecon treatment in chinese patients with immunoglobulin a nephropathy (igan) who have completed nef 301 study and continue to be treated with a stable dose of ras inhibitor therapy (aceis and/or arbs). during study open-label extension (ole) study, patients will receive nefecon for a 9-month period. the patient will come for a follow-up visit at 12 months after first dose.

Eligibility criteria:
inclusion criteria: 1. patients that completed study nef-301. 2. on a stable dose of ras inhibitor therapy (aceis and/or arbs) at the maximum allowed dose or maximum tolerated dose according to the 2012 kidney disease: improving global outcomes (kdigo) guidelines. 3. willing and able to provide written informed consent. 4. urine protein to creatinine ratio (upcr) equal to or more than 0.5 g/gram or average proteinuria equal or more than 0.75 g/day. 5. egfr equal to or more than 30 ml/min per 1.73 m2 using the chronic kidney disease epidemiology collaboration (ckd-epi) formula. exclusion criteria: 1. systemic diseases that may cause mesangial immunoglobulin a (iga) deposition. 2. patients who have undergone a kidney transplant. 3. patients with presence of other glomerulopathies and/or nephrotic syndrome. 4. patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (tb), human immunodeficiency virus (hiv), and chronic urinary tract infections. 5. patients with liver cirrhosis, as assessed by the investigator. 6. patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled. 7. patients with history of unstable angina, class iii or iv congestive heart failure, and/or clinically significant arrhythmia, as judged by the investigator. 8. patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the investigator. 9. patients with diagnosed malignancy within the past 5 years.
topography-guided lasik surgery

Conditions: Myopia

Summary: the investigators are analyzing outcomes of topography-guided lasik surgery in participants with myopia and myopic astigmatism

the investigators are analyzing outcomes of topography-guided lasik surgery in participants with myopia and myopic astigmatism. the investigators will be monitoring changes in anterior segment optical coherence tomography epithelial thickness maps. the investigators will compare preoperative maps to postoperative maps at one, three, six and twelve months. in addition, the investigators will measure changes in epithelial maps from postoperative month through twelve months to help understand what is happening to the corneal epithelium to try to explain why udva and cdva improves over time

Eligibility criteria:
inclusion criteria: * subjects age 18 and older with healthy eyes. nearsightedness between -0.50 diopters and -8.00 diopters. * subjects with up to 3.00 diopters of astigmatism. * subjects with a spherical equivalent of up to -9.00 diopters. exclusion criteria: * subjects under the age of 18. * subjects with excessively thin corneas. * subjects with topographic evidence of keratoconus. * subjects with ectatic eye disorders. * subjects with autoimmune diseases. * subjects who are pregnant or nursing. * subjects with more than 3.00 diopters of astigmatism
combined effect of dexamethasone and paracetamol for postoperative sore throat

Conditions: Pharyngitis

Summary: the investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

the postoperative sore throat is a common complication after the general anesthesia which decreases the quality of life. dexamethasone is known to effective for the prevention of postoperative sore throat. the combined effect of the dexamethasone and paracetamol for postoperative sore throat, however, is not investigated. the investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Eligibility criteria:
inclusion criteria: * patients scheduled for urologic surgery under general anesthesia * asa i-iii exclusion criteria: * patients with recent sore throat * patients with neck surgery * patients with anticipated difficult airway * patients with mallampati grade 3 * patients with severe cardiovascular or pulmonary disease * patients with allergic history to dexamethasone or paracetamol * patients with liver function disorder * patients with liver disease

Keywords: postoperative period anesthesia, general intubation, intratracheal dexamethasone acetaminophen
safety and tolerability study of multiple doses of pf-06305591

Conditions: Healthy

Summary: safety, tolerability and pk of repeated doses of pf-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.


Eligibility criteria:
inclusion criteria: * healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy).

Keywords: safety tolerability pk
meeting an unmet need in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objectives of this study is to examine the efficacy of the unified protocol in decreasing depression and anxiety among individuals with ms and the secondary outcomes (e.g., improved well-being, qol, coping, etc.) that may occur in tandem.

the primary objectives of this study is to examine the efficacy of the unified protocol in decreasing depression and anxiety among individuals with ms and the secondary outcomes (e.g., improved well-being, qol, coping, etc.) that may occur in tandem. to achieve this, the investigation has the following specific aims: specific aim 1: conduct a pilot randomized controlled trial (rct) of the unified protocol among individuals with ms to determine the effectiveness of the intervention in reducing depression and anxiety. hypothesis 1: individuals who participate in the unified protocol intervention will report a decrease in their depression and anxiety compared to individuals in the control group. specific aim 2: conduct a pilot rct of the unified protocol among individuals with ms to determine the effectiveness of the intervention in improving secondary outcomes of psychological well-being, qol, coping, and ms symptomatology over time. hypothesis 2: individuals who participate in the unified protocol intervention will report an increase in psychological well-being, qol, coping, and ms symptomatology over time compared to participants in the control group.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * 18 years of age or older * experiencing significant depression and/or anxiety * english-speaking * able to provide informed consent * access to the internet exclusion criteria: * history of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia) * current participation in another randomized controlled trial * cognitive impairment that would affect my ability to fully participate in the group * unable to attend group sessions * active participation in another formal clinical group or psychological therapy * any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study
assessment of lv/rv s and sr before and after percutaneous closure of asds

Conditions: Atrial Septal Defect, Secundum Type

Summary: the effect of atrial septal defect (asd) closure by using larger devices on the improvement in biventricular function remains an area of active research. therefore, the aim of the current study is to assess the degree of improvement in biventricular dimensions and function by using 2-dimensional echocardiography derived strain and strain rate and tissue doppler. moreover, to identify the relationship between the left and right ventricular systolic and diastolic function and device size.

in most echocardiographic studies, left ventricle (lv) systolic function was normal in the patients with asd and only a few cases had a reduced lv ejection fraction with severe right ventricle (rv) volume overload. the device closure of asd increases immediately the blood flow to the left ventricle and may unmask subtle abnormalities in systolic and diastolic function. currently, clinical research in cardiac mechanics is moving from short- and long-axis lv and rv function and ejection fraction to two and three- dimensional (2d, 3d) ventricular deformation studies (strain and strain rate quantiﬁcation). these methods are independent of ventricular geometry and allow quantiﬁcation of myocardial motion and deformation in different directions (longitudinal, radial, and circumferential), while conventional methods mainly rely on the assessment of radial function. strain imaging has also been used to demonstrate that patients who underwent device closure of an asd had better lv and rv longitudinal deformation than patients who underwent surgical closure of an asd. however, the effect of device size on the lv systolic and diastolic function is still under investigations. for all these reasons the researchers intend to measure rv and lv haemodynamic changes by 2-d transthoracic echocardiography (tte) derived tissue doppler and strain quantification in asd before and after transcatheter closure with special emphasis on the assessment of the relationship between device size and biventricular systolic and lv diastolic function.

Eligibility criteria:
inclusion criteria: * all asd patients who have been already selected and suitable for intervention before the starting time of the study. the criteria for asd intervention are either haemodynamically significant shunt fraction (qp/qs \> 1.5) or echocardiographic signs of right heart dilation or rv volume overload and pulmonary hypertension related symptoms. exclusion criteria: * patients with a large stretched secundum asd ≥ 36 mm, those with insufficient asd rims (except the aortic rim), sinus venosus or primum type asd, irreversible pulmonary hypertension, other associated structural heart diseases, coronary artery disease, lv systolic dysfunction, atrial fibrillation, or hypertension.

Keywords: left and right ventricular global longitudinal strain asd device closure
correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee arthroplasty

Conditions: To Evaluate a Linear Positive Correlation Between Plasma HbA1c and Synovial IL-6 in Diabetic Patients

Summary: evaluate the correlation between altered glycometabolic status and joint inflammation in diabetic patients with osteoarthritis undergoing knee replacement surgery


Eligibility criteria:
inclusion criteria: * diabetic patients * patients with osteoarthritis awaiting knee replacement surgery * patients awaiting knee replacement surgery * patients who agree to sign informed consent exclusion criteria: * patients less than 55 years of age. * patients over 85 years of age. * patients who are unable to understand and want. * patients with severe neurological disorders or with severe disabilities. * rheumatoid arthritis patients * cancer patients * patients suffering from chronic inflammatory bowel syndromes (rcu and crohn's disease) * patients on immunosuppressive therapy
efficacy of prostatic artery embolization (pae) in patients with severe benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hyperplasia

Summary: purpose: to evaluate the efficacy of prostatic artery embolization (pae) in patients with benign prostatic hyperplasia (bph) and refractory lower urinary tract symptoms (luts) in decreasing the volume of the prostate gland. participants: study participants will be recruited from unc urology clinics as well as referring providers. we will include 15 men who are experiencing luts not controlled by medication with estimated prostate gland weight between 80 and 150 grams. procedures (methods): enrolled patients will undergo the standard work-up for a surgical prostate procedure. in addition, the patient's arteries will be evaluated with a pelvic ct angiogram. then, patients will undergo prostatic artery embolization. follow up visits will be scheduled at 1, 3, 6, and 12 months after the procedure. at the end of the follow-up period, if reduction in prostate gland size has made the patient eligible for transurethral therapy, they may proceed to such procedure or elect to undergo no further surgical procedure, depending on residual symptoms. similarly, if insufficient gland size reduction has occurred, the patient may elect to pursue op or no further procedure if they are no longer bothered by luts.

this will be an open label pilot study with a small population undergoing an intervention to determine safety and efficacy.

Eligibility criteria:
inclusion criteria: * male * age \> 40 * prostate gland measures between 80 and 150 grams * have previously taken bph medication for 6 months without desired improvement of luts or has started medication and stopped due to unwanted side effects * moderate to severe luts as defined by ipss score \>18 * peak urine flow rate (qmax) \<12 ml/sec * capable of giving informed consent * life expectancy greater than 1 year exclusion criteria: * severe cardiac or pulmonary disease * uncontrolled diabetes mellitus * immunosuppression * neurogenic bladder and/or sphincter abnormalities secondary to parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc. * acute urinary retention * glomerular filtration rate less than 45 as approximated using using serum creatinine levels. * confirmed or suspected bladder cancer * recent (within 3 months) cystolithiasis or gross hematuria * urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology * active urinary tract infection * previous rectal surgery or history of rectal disease if pae, anoscopy or transrectal ultrasound are thought to potentially cause injury to the rectum due to the previous surgery or disease * previous pelvic radiation or radical pelvic surgery * confirmed or suspected malignancy of the prostate based on dre, trus or psa. (\> 10 ng/ml or \> 2.5 ng/ml and \< 10 ng/ml with free psa \< 25% of total psa without a negative biopsy) * uncorrectable coagulopathy including inr \> 2.5 or platelets \< 30,000

Keywords: prostate men hyperplasia
anxiety and burnout in anesthetists and intensive care unit nurses during covid-19 pandemic

Conditions: Sars-CoV2; Anxiety; Burnout

Summary: the aim is to measure anxiety level and burnout frequency of healthcare workers including attending physicians, residents and nurses working at intensive care unit during covid-19 pandemic. the study protocol had consisted of three parts. the first part was related to demographic details including age, sex, marital status, working position, past medical history. the second part of the survey was validated turkish form of beck anxiety inventory (bai) it has 21 questions. every question is a somatic symptom of anxiety. participants scored them regarding how this symptom bothered them past week. items have four possible answers: not at all (0 point), mildly (1 point), moderate (2 point), severe (3 point). total anxiety score can be between 0 and 63. participants were categorized as no or mild anxiety if the total beck anxiety score was between 0-16, and moderate to severe anxiety if it was more than 16 the last part of the survey was validated turkish form of maslach burnout inventory (mbi) to evaluate components of bos

our institution's icu has served 31 beds for covid-19 and 21 beds for other patients during pandemic with 27 attending physicians and 35 residents. number of night shifts for attending physicians and residents were 3 and 8 per month, respectively. the aim of the study was to evaluate the by measuring anxiety level and burnout frequency of hcws including attending physicians, residents and nurses in our institution's icu.

Eligibility criteria:
inclusion criteria: healthcare workers in our institute's intensive care units exclusion criteria: none

Keywords: anxiety burnout covid 19
carisma : cardiac arrhythmias and risk stratification after myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several invasive and non-invasive risk markers for life-threatening arrhythmia


Eligibility criteria:
inclusion criteria: * acute myocardial infarction (\< 21 days) * ejection fraction \<= 40 % or wall motion index \<= 1.3 exclusion criteria: * implantable loop recorder can't be implanted within 3 weeks after mi * nyha class iv * planned or previous icd implantation * planned cabg * severe valvular disease * pregnancy * life expectancy \< 1 year for non-cardiac cause

Keywords: acute myocardial infarction cardiac arrhythmias left ventricular dysfunction implantable loop recorder risk stratifiers
clinical trial on the effect of the sublimated mare milk supplement on primary biliary cholangitis

Conditions: Primary Biliary Cirrhosis

Summary: this study evaluates the effect of sublimated mare milk supplement on patients with biliary cholangitis

primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a rare chronic disease that primarily affects women. primary biliary cholangitis often progresses to the terminal stage of liver cirrhosis with its inherent complications. at this stage, the only way to save the patient's life is liver transplantation, and is accompanied by a number of painful symptoms (itching, mucous dryness, abdominal discomfort, fatigue), often restless legs syndrome, insomnia, depression and cognitive dysfunction. the goal of the treatment is to prevent the terminal stage of cirrhosis of the liver and to alleviate the accompanying symptoms. conventional drug therapy is aimed at slowing the progression of the disease and includes both approved for the use of these medications (ursodeoxycholic acid) and used outside the approved indications (derivatives of fibric acid, budesonide). the role of this clinical trial is to increase the effectiveness of therapy for this disease. against the background of the complexity of the treatment of primary biliary cholangitis, clinical medicine acquires a remedy in the form of a natural product - mare's milk, preventive, dietary, medicinal effects of which have been known for a long time. there are data from studies that have shown the efficacy and safety of using mare milk in patients with atopic dermatitis as well as with inflammatory bowel diseases. for the liver diseases, there are no reported studies. in this trial, there will be two parallel groups: interventional (supplement with standard treatment first for 3 months) and standard treatment group. differences in clinical, laboratory, liver encephalopathy and asthenia will be evaluated between groups.

Eligibility criteria:
inclusion criteria: * patients with morphologically verified diagnosis of primary biliary cholangitis * aged 18 to 75 years * willingness to consent to participate in the study * consent to adhere to treatment exclusion criteria: * alcohol and/or drug dependence * presence of liver cirrhosis class c based on child pugh classification * allergic reaction to dairy products * presence of mental diseases, severe concomitant pathology * pregnancy and/or lactation * lactose intolerance * refusal to participate in the study

Keywords: primary biliary cirrhosis primary biliary cholangitis mare milk