Kornimate/medical-research-clean huggingface dataset:
panex: partial nephrectomy under xenon

Conditions: Renal Function After Partial Nephrectomy

Summary: purpose of this study is to determine whether xenon - as compared to isoflurane - shows a nephroprotection after partial nephrectomy.

a partial nephrectomy is accompanied by ischemia time, followed by reperfusion. this frequently leads to a kidney injury of the remained tissue and decrease of the renal function after surgery. as it was shown that xenon has protective properties against ischemia/reperfusion injury, the investigators hypothesize that xenon application during partial nephrectomy leads to a stronger nephroprotection than an anesthesia with isoflurane. the study will be conducted by two investigator types: the study enrollment and the post-anesthesia follow-up will be performed by investigator i who is blinded to the study treatment. investigator ii will only perform general anesthesia for partial nephrectomy and will therefore necessarily be unblinded to the treatment conditions. patients will be randomly assigned to one of the following study groups. group 1 (xenon) will receive xenon for maintenance of balanced anesthesia for partial nephrectomy. group 2 (isoflurane) will receive isoflurane for the same surgery.

Eligibility criteria:
inclusion criteria: * patients willing and able to complete the requirements of this study * patients with renal carcinoma restricted to one kidney * patients undergoing partial nephrectomy * men and women \>= 18 yrs * informed consent exclusion criteria: * chronic renal failure with a gfr \< 60ml/min/1,73m2 body surface area * american society of anesthesiologists (asa)\>iii * hypersensitivity to the study anaesthetics * chronic obstructive pulmonary disease (copd) gold iv * acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support * severe cardial dysfunction new york heart association (nyha) \>iii * disabling neuropsychiatric disorders * increased intracranial pressure * pregnant or breastfeeding women * women of childbearing potential * presumed uncooperativeness or legal incapacity * lack of informed consent * participation in a concomitant trial within the last 30 days

Keywords: xenon isoflurane anesthetics, inhalation nephroprotection partial nephrectomy xenon versus isoflurane anesthesia
a multicenter trial of radiofrequency ablation vs. surgery as treatment of papillary thyroid microcarcinoma.

Conditions: Papillary Thyroid Microcarcinoma

Summary: the treatment of papillary thyroid microcarcinoma (ptmc) nowadays varies among physicians, surgeons and radiologist. the recently published articles show that the prognosis of ptmc by different means of treatment strategies tends to be good. but multicentered, randomized, parallel and prospective study is rare. rfa is the abbreviation of "radiofrequency ablation", which tends to be an alternative strategy except conventional surgery. the investigator aims to confirm whether rfa for treating ptmc braces same effectiveness and prognosis comparing with conventional surgery. besides, this trial also investigates the safety, economy and psychological quality under different treatments.

the incidence of thyroid carcinoma, especially the papillary thyroid microcarcinoma (ptmc), has increasingly rapidly, due to the development of technologies of diagnosis, during the past 20 years. ptmc defined by the world health organization (wto) as the largest dimension less than 1 cm. previous autopsy study demonstrated that the lesions are normal in many people and accompany them latently until they die because of another reasons. the long-term outcome of ptmc is good and, as expected, more than 90% ptmc aren't progress for many years. ultrasound-guided radiofrequency ablation (rfa) treatment was introduced to clinical practice few years ago. according to the 2015 american thyroid association (ata) guideline, the treatment of radiofrequency and laser ablation are mentioned to be used in recurrent thyroid cancer. but clinical practice shows that the rfa treatment for low risk ptmc braces well effect，low financial budget，high safety and even rare postoperative complication. although the cohort study was performed before, the real answer concerning about whether rfa is a rational choice for treating ptmc lacks more powerful evidences. the investigator considers to perform a randomized, controlled and multicenter study as a high-quality evidence and demonstrated the effect of prf in low risk ptmc treatment.

Eligibility criteria:
inclusion criteria: * newly diagnosis of ptmc (largest dimension\<10mm) * age \>=18 years old * bethesda category v or vi * single nodule without thyroid capsule contact * nodule has more than 3mm distance far from recurrent laryngeal nerve, carotid artery and trachea. * no clinical evidences show there is local or distant metastasis. * without chemotherapy, radiotherapy and other related therapies. * patients and their family member totally understand and sign the informed consent. exclusion criteria: * multifocal ptmc * combined with other types of thyroid cancer or hyperthyroidism. * contralateral vocal cord paralysis * with local or distant metastasis * pregnant woman * with radiation exposure history

Keywords: papillary thyroid microcarcinoma radiofrequency ablation surgery
psoriasis and the risk of cardiovascular disease. a prospective study

Conditions: Psoriasis; Cardiovascular Disease

Summary: there is growing evidence that psoriasis is a systemic disorder which enhances atherosclerosis and the risk of cardiovascular disease. epidemiological studies have shown an independent association between psoriasis and atherosclerosis, stroke and coronary artery disease. the main goal of this on-going study is to register data which will enable the identification of new markers of atherosclerosis activity and carotid plaque instability in patients with severe psoriasis.


Eligibility criteria:
inclusion criteria: * \>18 years old, psoriasis for more than 5 years, moderate to severe psoriasis (pasi \>10 or systemic treatment) exclusion criteria: * familiar hypercholesterolemia, ongoing infections and cancer disease
respiration detection from implanted cardiac devices in subjects with heart failure (rest-hf)

Conditions: Heart Failure

Summary: the purpose of this prospective, non-randomized, single-arm, research study is to evaluate the accuracy of acutely extracting respiratory rate and tidal volume from implanted cardiac device impedance in subjects with heart failure. in addition, to assess the feasibility of extracting respiratory rate from device egm under various conditions.


Eligibility criteria:
inclusion criteria: * subject must have heart failure and be undergoing implant of a new or replacement/upgrade medtronic dual-chamber implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator device for approved indications; * subject must be implanted with an right ventricle lead that supports bipolar pacing and sensing (i.e. a true bipolar defibrillation lead); * subject must receive a light conscious sedation or no sedation where breathing maneuvers can be performed and evaluated during the implant; * subject must be willing to provide informed consent for their participation in the study; * subject must be ≥ 18 years of age. exclusion criteria: * subjects who are unable or unwilling to voluntarily participate in any visit required by the study and to provide consent; * subject has congenital heart disease; * subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure; * subject has unstable coronary artery disease; * subject requires cardiac pacing at rest for rate support; * subject presents any concomitant conditions which in the opinion of the investigator would not allow a proper execution of the respiratory exercises as per protocol; * subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study; * subject is pregnant or breast feeding; * subject is legally incompetent; * subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from medtronic study manager.
pre-operative education modalities to decrease opioid use

Conditions: Prostatectomy; Opioid-Related Disorders

Summary: this is a triple-armed, randomized, controlled, non-blinded trial to study the effect of preoperative patient education in conjunction with a limited opioid peri-operative analgesia program on post-operative opioid use following radical prostatectomy. patients will be randomized into three education arms: usual care (variable provider-dependent education), text handout, or text handout and pre-recorded video. the impact of patient education on outcomes of in-hospital, post-discharge, and persistent opioid use will be studied.

this is a triple-armed, randomized, controlled, non-blinded trial that will be conducted at virginia mason medical center (vmmc). men of age 18 or older undergoing robotic assisted radical prostatectomy (rarp) for prostate cancer will be approached to participate in the study. recruited patients will be randomized into three main groups based upon opioid education given to the patient before surgery: usual care group, text handout group, and text handout with pre-recorded video group. during their pre-operative visit, the usual care group will undergo usual pre-surgery patient education care dependent on their provider. the study group will receive additional standardized pre-operative education including the topics of: 1. description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after rarp. 2. efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids. 3. adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction. patients in both usual care and study groups will receive standardized multimodal analgesia program with minimal opioids used. primary outcomes measured will include in-hospital and post-discharge opioid use, pain levels and time to return of bowel function. secondary outcomes will include daily measures of patient satisfaction and quality of life, feeling of preparedness to manage post-operative pain, as well as incidence of prolonged opioid use at 90 days after surgery.

Eligibility criteria:
inclusion criteria: * age \> 18 * undergoing rarp at vmmc * consent to participate in the study exclusion criteria: * long-term opioid use defined as use of opioids on most days for \>3 months * history of drug or alcohol dependence * concurrent surgery during radical prostatectomy * history of allergy to opioid analgesics, nsaids, acetaminophen or local anesthetics * inability or unwillingness to give written informed consent

Keywords: opioid education post-operative opioid use
adipose tissue derived stromal vascular fraction (svf) application in treatment of long bones nonunion

Conditions: Nonunion of Fracture

Summary: nonunion is a major complication of fractures.per cutaneous bone marrow concentrate (bmc) application around fracture ends is being utilized with great success . mesenchymal stem cells (mscs)are one of the major cell types found in bmc responsible for results adipose tissue is an alternative source for mscs. besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration. this retrospective analysis to report the outcome in patients treated with fluoroscopic guided percutaneous injection of svf at the site of fracture as an outpatient procedure between november 2012 to august 2018.

nonunion is of major complication of fractures .the overall rate of non-union is still not clear but estimates from the published literature suggests a range between 5-10% of the total fractures.the gap in non-healing management has instigated the search for novel osteo-inductive substances. bone marrow concentrate is being utilized for many year with excellent results .mesenchymal stem cells (mscs)are one of the major cell types of the bone marrow aspirate concentrate (bmac)that self-renovates and differentiates into multiple cell types of mesodermal origin such as osteoblasts, chondrocytes, and adipocytes. adipose tissue is an alternative source for mscs .besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration. this retrospective analysis was conducted to report the outcome in patients treated with fluoroscopic guided percutaneous injection of svf at the site of fracture as an outpatient procedure between november 2012 to august 2018. the purpose of this study is to report the feasibility of minimally invasive percutaneous injection with autologous svf and study the osteo-inductive efficacy of adipose derived stromal cells in svf in the management of non-union.

Eligibility criteria:
inclusion criteria: * non-union or delayed union diagnosed after x-ray examination more than 4 cm distance from the joint exclusion criteria: * multiple major fracture or untreated major fracture * infected fracture * hiv, hepatitis b or hepatitis c infection at the time of screening * diagnosis of cancer * active treatment with immunosuppressive drugs or anticoagulant agents * known allergic reaction to components of study treatment and/or study injection
role of neoadjuvent radiotherapy in locally advanced cancer rectum

Conditions: Rectal Adenocarcinoma

Summary: this is a retrospective study comparing neoadjuvent short course radiotherapy to conventional chemoradiation in locally advanced cancer rectum and the effect of both regimens in overall survival and disease free survival

colorectal cancer is the third most common cancer diagnosed in the western world. in 2019 there were approximately 44180 new cases of rectal cancer diagnosed in the united states. due to the close proximity of the rectum to pelvic structures and organs, the absence of a serious membrane surrounding the rectum and the restriction of the surgical view and access by the pelvic cavity, the locoregional recurrence rate in rectal cancer is relatively high after surgery alone. neoadjuvent therapy rather than surgery followed by adjuvent therap has been the preferred approach world wide in treatment of rectal cancer since the 2004 publication of the seminal german cao/aro/aio-94 study ,which compared preoperative with postoperative chemoradiation in 823 patients the use of neoadjuvent therapy is recommended for all newly diagnosed rectal adenocarcinoma with a clinical stage t3 or t4 based on trans rectal endoscopic ultrasound or pelvic mri .neoadjuvent therapy may comprise of either radiotherapy alone or in combination with chemotherapy, commonly prescribed chemotherapy agents include 5-fluorouracil and oxaloplatin. both short course radiotherapy (25 gy in 5 fractions) and long course radiotherapy (50.4gy in 28 fractions, conventionally fractionated therapy)can be applied as neoadjuvent radiotherapy. several phase lll rcts,including three large well-designed international rcts have reported that short course neoadjuvent radiation treatment improves local control compared with surgery alone in patients with respectable rectal cancer. also ,neoadjuvent chemoradiation with long course radiotherapy can be recommended for most patients with stage ll- lll rectal cancer with the aim of reducing the risk of local recurrence, for reducing rates of perioperative and post operative complications and in an attempt to avoid radical surgery with permanent colostomy.

Eligibility criteria:
inclusion criteria: * histologically proved adenocarcinoma of the rectum * age between 18 and 70 yrs * t3 and t4 n1,n2 respectable tumor * the who performance score 0-2 * have a free metastatic work up excluded by chest x-ray , abdominal ultrasonography or ct pelviabdomen exclusion criteria: * patients with locally advanced inoperable disease locally recurrent rectal cancer * had a history of malignant tumor within 5 years except the skin cancer * pregnant or lactating women * previous irradiation in pelvis * there was contraindication for neoadjuvent radiotherapy or surgery * known metastatic disease * mental disorder
effect of dolutegravir intensification on hiv-1 reservoirs

Conditions: HIV-1-infection

Summary: persistent hiv viremia occurs in most art-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (lr) and/or residual ongoing viral replication during cart, for instance in anatomical compartment where drug penetration is sub-optimal. the question of the sources of persistent viremia is of the utmost importance. if ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.we propose to better characterize the role ongoing viral replication to hiv persistence under art by undertaking a treatment intensification trial with high-dose dolutegravir. tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.


Eligibility criteria:
inclusion criteria: * hiv-infected adults receiving cart for at least 3 years * undetectable viral for at least 3 years * dtg/3tc/abc as cart regimen in the previous 6 months. * cd4 counts higher than 200 cells per μl exclusion criteria: * active hepatitis c or b * unstable liver disease * renal impairment (estimated glomerular filtration rate \<50 ml per min), * gastrointestinal disorders that would affect the absorption of study treatment * current use of drugs with significant interactions with dolutegravir * current use of drugs with an impact on inflammation such as steroids. * hospitalization for acute illness within the previous 8 weeks * pregnancy or breastfeeding. * anal or rectal lesions impeding rectal biopsies * decreased platelets count or coagulation disorder.
combination therapy with sitagliptin and lansoprazole to restore pancreatic beta cell function in recent-onset type 1 diabetes

Conditions: Type 1 Diabetes

Summary: sanford research/usd proposes to study the combination therapy of oral administration of sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells still present in patients with recent-onset diabetes and possibly regenerating their beta cells, while safely down-regulating the autoimmune response directed against the beta cells.


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes, based on american diabetes association criteria, recently diagnosed (within the 6 months before screening) and confirmed by the presence of at least 1 diabetes related autoantibody (either glutamic acid decarboxylase \[gad\], insulinoma-associated protein \[ia 2\], or insulin, the latter measured within 10 days after starting insulin therapy). * male or female aged between 11 and 45 years, inclusive. * able to swallow study capsules. * willing to comply with "intensive diabetes management" as directed by the investigator, with the goal of maintaining blood glucose as close to american diabetes association recommendations as possible. * willing to comply with the schedule of study visits and protocol requirements. exclusion criteria: * use of a glp 1r agonist or dpp 4 inhibitor within 1 month before enrollment. * use of a ppi within 1 month before enrollment. * use of an oral hypoglycemic agent within 1 month before enrollment or use of thiazolidinediones within 3 months before enrollment (although thiazolidinediones may be used \<7days before enrollment). * females of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period. * females who are pregnant or breastfeeding at the time of enrollment. * subjects with any of the following conditions: * renal insufficiency, defined as estimated glomerular filtration rate (gfr) less than 50 ml/min at screening, calculated using the modification of diet in renal disease (mdrd) equation. * history of a serious hypersensitivity reaction to sitagliptin or lansoprazole, such as anaphylaxis or angioedema. * severe hepatic insufficiency. * history of pancreatitis or gallbladder disease * any significant medical condition, which in the opinion of the investigator or medical monitor would interfere with study participation.

Keywords: diabetes hgb a1c beta cell regeneration
pilot study to develop 3 tesla mri for evaluation of renal tumors

Conditions: Kidney Neoplasms

Summary: the goal of this clinical research study is to find out if "3 tesla" mri is as good as ct scan in the evaluation of kidney tumor(s). objectives: to provide preliminary data to enable subsequent development of an mri protocol at 3 tesla for evaluation of renal tumors and their vascular supply, which can be adopted in patients who are unable to undergo ct evaluation.

"3 tesla" mri is a new mri scanner that in theory, can produce better images than currently available mri scanners. currently, ct scanning is the main way of evaluating tumors in the kidneys. however, there are some patients who cannot have ct scans (usually, because of allergy to ct contrast medium or kidney damage/failure). it is with these patients that researchers are hoping to use a technique (using mri) that is as good as ct scanning. as part of your standard of care, your doctor is requesting a ct scan of your kidneys and abdomen. if you take part in this study, you will have a "3 tesla" mri scan of your kidneys and abdomen as well, within 15 days following your routine ct. for the "3 tesla" mri scan, you will be lying flat on the mri scanner, and as with a regular scan, you will have a small needle placed in a vein in your arm to inject the contrast dye. a diuretic, lasix, will be given to help distend the internal tubes in the kidney to help view your kidney better. the mri scan will take between 1-2 hours to perform. as with regular scans, you may be asked to hold your breath on occasions. if there is a concern about your kidney function, blood (about 1 teaspoon) will be drawn to test your kidney function before you have the mri. your participation in the study will be complete at the end of the mri scan. the routine ct scan will be the main decision making examination. however, if the mri shows something different and potentially relevant to your care, your referring physician will be informed. this is an investigational study. a total of 45 patients will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. patients who have undergone or are due to undergo a ct renal protocol study, in the course of pre-operative evaluation for renal tumor surgery. 2. written informed consent will be obtained. exclusion criteria: 1. patients with an allergy to both gadopentetate dimeglumine and gadodiamide mri contrast agents. 2. patients with certain metallic implants, e.g., cardiac pacemakers, cardiac defibrillators, aneurysm clips, neurostimulators, and certain metallic foreign bodies. implanted medical devices must be mri compatible at 3.0 tesla field strengths. 3. patients with claustrophobia, or requiring sedation for the mri scan.

Keywords: kidney neoplasms renal tumors magnetic resonance imaging 3 tesla mri mri