Kornimate/medical-research-clean huggingface dataset:
randomized trial of hifu vs. cryo for prostate cancer

Conditions: Prostate Cancer; Prostate Cancer Stage I; Prostate Cancer Stage II; High Intensity Focused Ultrasound; HIFU; Cryoablation

Summary: hifu has been fda approved and is widely utilized across the united states and europe for the treatment of prostate cancer. despite this, hifu has not been offered within scpmg until now due to growing patient demand. we have offered cryoablation. this pilot study will determine the efficacy of hifu vs. cryoablation focal therapy for early stage prostate cancer within scpmg. we hope to elucidate whether outcomes are similar between the two modalities.

all men presenting with elevated prostate specific antigen (psa) will be required to undergo an initial multiparametric mri (mri) and 14 core systematic biopsy. decipher genomic testing will be run on all prostate cancer specimens. 48 men with with unifocal low-intermediate risk prostate cancer (clinical stage t1-t2, gleason group 1-2) prostate cancer will be offered focal therapy vs. conventional therapy (surgery or radiation) via shared decision making. those who elect focal therapy (ft) will be enrolled and randomized 1:1 to hifu or cryoablation. men with negative biopsy, multifocal disease, or unfavorable intermediate risk or higher disease will be excluded and offered standard therapy (surgery or radiation). following treatment, mpmri and biopsy will be performed at 3mo. baseline, 3mo, 6mo and 12mo post-treatment psa will be obtained. in field and out of field cancer recurrence will be determined. baseline and 3mo american urologic association symptom score (auass) and international index of erectile function (iief) will be recorded as well as any treatment related side-effects or complications. spaceoar hydrogel will be utilized for all posterior lesions.

Eligibility criteria:
inclusion criteria: 1. all men age 40 or older with gleason group 1 or 2 prostate cancer involving a single or adjacent sextants 2. psa \< 10 3. mpmri without extracapsular extension or seminal vesicle invasion (non-focal mri or organ confined) 4. mpmri which is either nonfocal or concordant with biopsy. exclusion criteria: 1. gleason group 3 or higher 2. multifocal disease 3. mpmri with ece or svi 4. psa \> 10 5. active anorectal disease 6. age \> 80
thermosoftening of double-lumen tube to reduce sore throat

Conditions: Hoarseness; Sore Throat; Vocal Cord Injuries

Summary: the purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.


Eligibility criteria:
inclusion criteria: * patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes exclusion criteria: * preoperative hoarseness or sore throat * history of upper airway diseases * anticipated difficult airway * anesthesia time longer than 6 hours

Keywords: double-lumen tube intubation thermosoftening
f.a.s.t.-be fast stroke warning signs study

Conditions: Stroke, Acute

Summary: the goal of this randomized controlled trial is to learn whether the be fast (balance, eyes, face, arm, speech, and time) acronym works at least as well or better than the f.a.s.t. (face drooping, arm weakness, speech difficulty, time to call 911) acronym in helping participants learn and remember the warning signs of a stroke. the main questions it aims to answer are: * does the be fast acronym increase understanding among participants that calling 911 is the right first step they should take if a stroke is suspected? * does the be fast acronym perform as well as or better than the f.a.s.t. acronym in helping participants remember stroke warning signs on a letter-aided open-ended basis? researchers will compare the be fast acronym to the f.a.s.t. acronym to see if the be fast acronym works at least as well as the f.a.s.t. acronym in teaching participants about the warning signs of a stroke and the importance of calling 911 if they suspect a stroke. participants will: * take a survey about their knowledge of stroke and its symptoms * watch a short video about one of the acronyms and then answer more questions about what they learned * take another survey after 30 days about the acronym they learned about


Eligibility criteria:
inclusion criteria: * able and willing to provide written informed consent; * have access to a computer, tablet or mobile device with internet services; * proficient in reading and writing the english language; and * reside outside a medical facility. exclusion criteria: * not able to provide written informed consent; * do not have access to a computer, tablet or mobile device with internet; * not proficient in reading and writing in english language; or * reside in a medical facility.
prospective procedural data collection for continuous improvement of the kodex - epd™ system performance.

Conditions: Cardiac Arrhythmia

Summary: the purpose of the kodex epd field study is to evaluate the performance of the kodex-epd system and collect procedural data and medical images for philips' internal research and development activities (r\&d) related to the kodex-epd system, as well as for marketing and publication purposes. the kodex-epd system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.


Eligibility criteria:
inclusion criteria: * cardiac ablation exclusion criteria: * there is no exclusion criteria
post-operative sore throat as determined by endotracheal tube inflation technique

Conditions: Post Operative Sore Throat; Dysphagia; Hoarseness

Summary: the purpose of this study is to test whether the incidence of sore throat and other tracheal co-morbidities such as dysphagia and hoarseness can be lessened by use of a cuff manometer at the beginning of surgery to inflate to the proper pressure compared to the standard technique. the investigators hypothesis is that inflation of the endotracheal balloon using a cuff manometer immediately after intubation will reduce the incidence of sore throat and other tracheal co-morbidities.


Eligibility criteria:
inclusion criteria: * scheduled for general anesthesia requiring endotracheal intubation with planned duration of at least 2 hours * asa i-3 exclusion criteria: * planned prolonged intubation * planned postoperative icu admission * non english speaking * mentally impaired * existing tracheal stoma * nasogastric tube in place preoperative * thyroid / intra-oral surgery * previous general anesthesia within the last 2 weeks * use of steroids within one week before surgery (iv,inhaled, oral)

Keywords: sore throat dysphagia hoarseness post operative endotracheal intubation
remimazolam besylate and propofol sedation on hemodynamic for coronary artery bypass graft patients

Conditions: Coronary Artery Disease

Summary: in the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. for these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. however, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. in other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. the aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: * sign the informed consent form voluntarily and follow the plan requirements; * age over 60 years old; * post coronary artery bypass surgery; * anticipated mechanical ventilation duration \>8 hours * admission to the cardiac surgery intensive care unit of zhongshan hospital, fudan university exclusion criteria: * delirium before surgery * severe cognitive dysfunction before surgery * patients with over degree ii a-v block or consistent bradycardia * patients who are still not awake 12 hours after surgery * patients who are agitated or cannot follow command * patients with mechanical circulatory support (ecmo, iabp) * patients who are allergy to propofol or remimazolam * bmi≥30kg/m2 * patients with much drainage, the surgery ask for blood pressure control or reopen the chest
evaluation of the parietex tm parastomal no hole mesh for repair of parastomal hernias in end-colostomies

Conditions: Parastomal Hernia

Summary: short title: pharaoh study: laparoscopic parastomal hernia repair with a no hole mesh. objectives: evaluation of operative complications, colostomy function, quality of life and recurrence rate after laparoscopic repair of parastomal hernias in end-colostomies with a parietextm parastomal no hole mesh. principle investigators: prof. dr. frederik berrevoet, university hospital ghent dr. filip muysoms, az maria middelares ghent patient selection: adult consecutive patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy. a logbook will be kept of adult patients undergoing a parastomal hernia repair in the participating centers during the study period that are not entered in the study, including the reason for non inclusion. a total of 100 patients will be included during 24 months or until the sample size has been reached. exclusion criteria: previous repair of a parastomal hernia at the same site, emergency operations, open parastomal hernia repair, parastomal hernias at an ileostomy or an ileal conduit stoma, loop colostomies, patients under the age of 18 years, pregnant women, asa score 4 or more, no informed consent of the patient, patients unable to complete the stoma quality of life assessment. primary endpoint: evolution of quality of life with the stoma-qol score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively. secondary endpoints: quality of life of the patients with the eurahs qol score: preoperatively, at 1 month, 12 months and 24 month postoperatively. recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. intra-operative and post-operative complications, post-operative hospital stay, operation time.

primary endpoint: evolution of quality of life with the stoma-qol score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively. secondary endpoints: quality of life of the patients with the eurahs qol score: preoperatively, at 1 month, 12 months and 24 month postoperatively. recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. intra-operative and post-operative complications, post-operative hospital stay, operation time.

Eligibility criteria:
inclusion criteria: - adult patients, planned for primary elective laparoscopic hernia repair of an end-colostomy. exclusion criteria: * previous repair of a parastomal hernia at the same site * emergency operations * open parastomal hernia repair * parastomal hernias at an ileostomy or an ileal conduit stoma * loop colostomies * patients under the age of 18 years * pregnant women * asa score 4 or more * no informed consent of the patient * patients unable to complete the stoma quality of life assessment

Keywords: ostomy hernia parastomal sugarbaker
bigfoot unity real world study

Conditions: Type 1 or Type 2 Diabetes

Summary: this study is observational, designed to collect real world use and safety data for those using the bigfoot unity diabetes management system for 12 months. participants will be those with a prescription to use the bigfoot unity system. medical practices prescribing bigfoot unity and sponsor representatives will provide information about the study to current users and individuals considering initiation of the bigfoot unity system. during the course of the study, participants will be asked to use the bigfoot unity system in accordance with the prescription provided by their healthcare professional (hcp).


Eligibility criteria:
inclusion criteria: 1. type 1 or type 2 diabetes diagnosis 2. hcp-prescribed, registered bigfoot unity users who have used the bigfoot unity system 2 weeks or less 3. age 12 years or older at time of electronic informed consent 4. using both long-acting and rapid-acting insulins that are compatible for use with the bigfoot unity system 5. using long-acting insulin no more than 1 time per day 6. must have baseline hba1c collected within 90 days prior to starting the bigfoot unity system 7. able to read and understand english 8. participant or legally authorized representative for minors has the capacity to provide electronic informed consent 9. resident of the united states 10. persons who are using a phone that is compatible with bigfoot unity and not shared with a family member or a caregiver exclusion criteria: 1. females who are pregnant or intending to become pregnant during participation in the study 2. persons with implantable medical devices such as pacemakers 3. persons on dialysis or other serious medical conditions that would impact the ability to use the device or manage their diabetes 4. persons taking or expected to be taking \>500mg vitamin c supplements on routine basis 5. persons employed by the sponsor or jchr
clinical evaluation of a new aspheric intraocular lens.

Conditions: Cataract

Summary: this study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.


Eligibility criteria:
inclusion criteria: * patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery. * patients must be undergoing primary cataract surgery with iol in-the-bag implantation, requiring a iol power from 10 to 30 diopters. exclusion criteria: * patients with corneal damage. * patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. * patients with any ocular pathology, other than the cataract, having repercussions on visual function:
a biomarker study of ath434 in participants with msa

Conditions: Multiple System Atrophy

Summary: this study will assess the safety and efficacy of ath434 in participants with a clinical diagnosis of multiple system atrophy


Eligibility criteria:
inclusion criteria: 1. participant has clinical features of parkinsonism. 2. participant has evidence of orthostatic hypotension and/or bladder dysfunction. 3. participant has ataxia and/or pyramidal signs on neurological examination. 4. participant has biomarker evidence of msa in biologic fluid and on mri. exclusion criteria: 1. participant is unable to swallow study drug. 2. participant is unable to attend study visits or complete study procedures. 3. participant has structural brain abnormality on mri. 4. participant has any significant neurological disorder other than msa. 5. participant has an unstable medical or psychiatric illness. 6. participant has a contraindication to, or is unable to tolerate, mri or lumbar puncture.

Keywords: multiple system atrophy ath434 neurodegenerative disease shy-drager syndrome movement disorders autonomic dysfunction synucleinopathies atypical parkinsonism biomarkers
predictors of acute toxicity and flap failure after adjuvant treatment for locally advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: head and neck cancer treatment may have significant functional consequences. decisions about treatment are usually hard to make, as they must strike a balance between efficacy of the treatment and likelihood of survival. reconstructive surgery with flaps plays a key role in the head and neck cancer resection in order to achieve local control, but often leaves a large, disfiguring composite defect that not only compromises the patient's functional and aesthetic outcome, but also significantly affects quality of life. adjuvant treatment, including post operative radiation therapy (port) and chemotherapy, is crucial in improving locoregional control and survival in locally-advanced cases and the flaps are usually included in radiotherapy fields. fourthysix patients undergoing to reconstructive surgery followed by radiation or chemioradiation between decembre 2017 to december 2022 at san raffaele hospital will be enrolled in this study. the first aim of the study is to understand potential predictors of the occurrence of overall acute toxicity following adjuvant treatment in locally-advanced head and neck cancers submitted to upfront surgery with flap reconstruction. by analyzing patient data and treatment variables, the study aims at identifying factors that may influence the incidence and severity of acute treatment-related toxicities, such as mucositis, dysphagia, xerostomia and dermatitis. the second aim of the study is to evaluate whether the same variables may influence the viability and integrity of the flap at the end of the adjuvant treatment.


Eligibility criteria:
inclusion criteria: * locally advanced head and neck cancer squamocellular carcinoma * treated with post operative radiotherapy +/- chemotherapy * surgical resected with flap reconstruction exclusion criteria: * salvage surgery after primary relapse * previously irradiated * recurrent/metastatic

Keywords: flap reconstructions flaps head and neck cancer toxicities adjuvant chemoradiation
efficacy, safety and tolerability of avp-786 for the treatment of agitation in patients with dementia of the alzheimer's type

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type

Summary: participants with agitation secondary to dementia of the alzheimer's type. the diagnosis of probable alzheimer's disease (ad) was to be based on the "2011 diagnostic guidelines for alzheimer's disease" issued by the national institute on aging (nia)-alzheimer's association (aa) workgroups.

eligible participants for this study must have had a diagnosis of probable ad and must have had clinically meaningful agitation secondary to ad. this was to be a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment. approximately 380 participants were to be enrolled at approximately 60 centers in north america. study medication was to be administered orally twice-daily from day 1 through day 85. screening was to occur within approximately 4 weeks prior to randomization. following screening procedures for assessment of inclusion and exclusion criteria, eligible participants were to be randomized into the study.

Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease (ad) according to the 2011 national institute on aging-alzheimer's association (nia-aa) working groups criteria * the participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization * the diagnosis of agitation must meet the international psychogeriatric association (ipa) provisional definition of agitation * either out patients or residents of an assisted-living facility or a skilled nursing home * clinical global impression of severity of illness (cgis) score assessing agitation is \>= 4 (moderately ill) at screening and baseline * mini-mental state examination (mmse) score is between 6 and 26 (inclusive) at screening and baseline * caregiver who is able and willing to comply with all required study procedures. in order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant. exclusion criteria: * participant has dementia predominantly of non-alzheimer's type (e.g., vascular dementia, frontotemporal dementia, parkinson's disease, substance-induced dementia) * participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease) * participant with myasthenia gravis

Keywords: agitation dementia alzheimer's disease
dry blood spot screening test for biliary atresia（dbs-screba）

Conditions: Hepatobiliary Disease; Biliary Atresia; Neonatal Cholestasis

Summary: our study aims to develop a screening test for biliary atresia (ba) using dry blood spot to improve patient survival by early diagnosis. newborn screening dry blood spot will be examined for the direct bilirubin (db), γ-gt or matrix metalloproteinase-7 (mmp-7) levels. these findings will promote early diagnosis for ba and hence improve the survival.

ba accounts for approximately 60% of the liver transplantations in infants younger than 1 year of age. the diagnosis of ba remains a clinical challenge because affected neonates have signs, symptoms, and serum liver biochemistry that are also seen in those with other causes of neonatal cholestasis. the success of the kasai procedure is varied, but a good outcome is correlated with an early diagnosis. unfortunately, most ba are usually identified later and the average age at surgery is about 60 days. to address this problem, some research groups screen infants for the pale stools or measure bilirubin level in the serum. however, these screening programs have not yet to be implemented because of several reasons. recently, the relative abundance of serum mmp-7 was suggested to have discriminatory features for infants with ba. nevertheless, whether the level of mmp-7 elevates in newborn dry blood spot of ba is still undefined. in this study, we will explore a screening strategy based on db, γ-gt or mmp-7 measurement in newborn screening blood spot, and identify whether db , γ-gt or mmp-7 measurement in the newborn period could be sensitive and specific for ba.

Eligibility criteria:
inclusion criteria: * neonates born in shanghai exclusion criteria: * subjects who do not agree with study protocol * subjects who join other clinical trials

Keywords: dry blood spot test biliary atresia