Kornimate/medical-research-clean huggingface dataset:
anti-thrombotic monotherapy in heartmate 3 left ventricular assist system (lvas)

Conditions: Heart Failure; Cardiovascular Diseases

Summary: the purpose of this prospective controlled study is to obtain a multi-center safety and feasibility data on patients managed with anti-thrombotic monotherapy with heartmate 3 lvas.

patients implanted with the heartmate 3 lvas will be screened for participation in the study with established stability at 6 months after implantation of the device. if inclusion criteria are met, patients will be transitioned to a single anti-thrombotic therapy with acetylsalicylic acid (asa) or equivalent antiplatelet therapy and anticoagulation with warfarin will be withdrawn. asa will be administered in a minimum dose of 100 mg per day with dosage adjustments based on verifynow testing up to a maximum of 200 mg daily. the primary endpoints will be analyzed at 90 and 180 days after initiation of the single antiplatelet therapy.

Eligibility criteria:
inclusion criteria: * patients implanted with heartmate 3 lvas irrespective of intended goal of treatment of bridge to transplant or destination therapy * a minimum of 6 months since heartmate3 lvas implantation free of thromboembolic events and pump malfunction * evidence of forward flow across the aortic valve (with aortic valve opening of at least 1:2 per cardiac cycle) at baseline echocardiography (echo) or after speed reduction as long as no evidence of progression of heart failure is noted, based on a combination of biomarkers and clinical assessment follow-up (see appendix iii); clinical assessment will include review of the biomarkers, invasive or non-invasive hemodynamics (as available or indicated) and clinical physical examination exclusion criteria: * absence of an informed consent * presence of any prosthetic valve or central aortic valve repair (e.g. park's stitch) * presence of any other ancillary circulatory assist device system * known history of major thrombotic event e.g. deep vein thrombosis (dvt) * known history of stroke * left atrial appendage in patients with atrial fibrillation or flutter not addressed by resection or exclusion at a time of the implant * evidence of any intracardiac thrombus evidenced by transoesophageal echocardiography * any other clinical indication for a use of long-term anticoagulation using a vitamin k antagonist or thrombin inhibitor (e.g. specified known genetic thrombotic mutation mandating the therapy, malignancy)

Keywords: mechanical circulatory support anti-thrombotic monotherapy
weekly carboplatin/docetaxel for recurrent ovarian/peritoneal cancer

Conditions: Ovarian Carcinoma; Primary Peritoneal Carcinoma

Summary: the purpose of this study is to determine the safety and efficacy of this regimen in women with ovarian or peritoneal cancer


Eligibility criteria:
inclusion criteria: * recurrent ovarian or peritoneal cancer exclusion criteria: * no prior chemotherapy
transplantation of autologously derived mitochondria following ischemia

Conditions: Extracorporeal Membrane Oxygenation Complication

Summary: the investigators propose a robust therapeutic intervention to ameliorate myocardial ischemia/ reperfusion injury and significantly decrease morbidity and mortality in patients requiring extracorporeal membrane oxygenation (ecmo), by direct injection of autogeneic mitochondria into the ischemic myocardium.

autologous mitochondria will be delivered to the ischemic heart muscle in one of two ways, during clinically indicated surgical procedure or during clinically indicated cardiac catheterization. for surgical re-operation subjects: after the subject's chest is open, 1-2 6mm biopsies will be collected from the exposed skeletal muscle of the chest wall. the tissue will be processed at bedside to extract the autologous mitochondria. surgery will proceed as clinically indicated. prior to closure of the chest, autologous mitochondria will be injected via 5-10 injections of approximately 0.1 ml each to the damaged area (if damaged muscle is local) or via injection into the proximal aorta while cross-clamped for clinically indicated surgery for global distribution of mitochondria via the coronary arteries if there is no evident area of damage. following completion of surgical maneuvers the mitochondria will be injected into the aorta and the cross-clamp will be removed. if there is global injury but a cross-clamp is not clinically indicated, direct injection into the myocardium will occur throughout the ventricle as previously described. chest closure will then occur as and if clinically indicated for both techniques. for catheterization subjects: once in the catheterization lab, the temporary chest closure will be removed and 1-2 6 mm biopsies will be collected from the exposed skeletal muscle of the chest wall by the cardiac surgery team. the tissue will be processed at bedside to extract the autologous mitochondria. the catheterization will proceed as clinically indicated. prior to completion of the procedure (interventional to restore blood flow or hemodynamics), mitochondria will be infused in 5 ml of buffer as conducted in large animal studies (5) via intracoronary infusion followed by a 5 ml flush with normal saline. total dose of mitochondria will be equal to direct injection subjects, with a larger dilution to allow to infusion via cardiac catheter. if there is no marked improvement in ventricular function following the injection/infusion of autologous mitochondria and the subject has a clinically indicated procedure in the days following the initial delivery, a second injection/infusion will be completed. at this time the follow up schedule will be reset to day 0.

Eligibility criteria:
inclusion criteria: * pediatric cardiology patients under the age of 18 on ecmo * concerns for ischemic injury on the cardiac intensive care unit exclusion criteria: * known mitochondria disorders
dermatological evaluation of topic compatibility-dermacyd tina gel tangerina mix

Conditions: Healthy

Summary: the purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product dermacyd tina gel tangerina mix


Eligibility criteria:
inclusion criteria: * phototype skin i,ii, iii e iv * integral skin test in the region exclusion criteria: * lactation or gestation * use of antiinflammatory and/or immunosuppression drugs * personnel history of atopy * history of sensitivity or irritation for topic products * active cutaneous disease * use of new drugs or cosmetics during the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: hygiene
radioprotective light-weight caps in the interventional cardiology setting

Conditions: Occupational Exposure to Radiation

Summary: the primary objective of the present trial is to compare the radiation attenuation provided by xpf caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. the second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the xpf protection caps compared to the standard fabric caps.

the primary objective of the present trial is to compare the radiation attenuation provided by xpf caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. the second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the xpf protection caps compared to the standard fabric caps. for more information please contact dr. raul herrera, md, director baptist cardiac and vascular institute baptist hospital of miami.

Eligibility criteria:
inclusion criteria: * interventional cardiologist practicing in baptist cardiac \& vascular institute * cardiac procedure requiring c-arm fluoroscopy exclusion criteria: * interventional neuroradiologists and interventional radiologists will not be included in this study.

Keywords: occupational exposure to radiation
assessment of the v600e mutation in the b-raf gene in chronic lymphoproliferative disease

Conditions: Hairy Cell Leukemia; Splenic Marginal Zone Lymphoma

Summary: the presence of a specific mutation in the gene known as b-raf has been found in patients who have hairy cell leukemia. in this study this specific mutation known as v600e will be ascertained in peripheral blood samples of patients who have this disease and in a group of patients who have a similar chronic lymphoproliferative conditions such as splenic marginal lymphoma. the finding of this specific mutation will help to verify or exclude the diagnosis of hairy cell leukemia and determine whether patients are in remission.


Eligibility criteria:
inclusion criteria: patients over the age of 18 years - exclusion criteria: patients less than 18 years in age or mentally defectives. -
partial versus total knee replacement in bicompartmental gonarthrosis (medial and patellofemoral): prospective functional assessment study

Conditions: Knee Disease

Summary: the study is, in accordance with current legislation, definable as a prospective single-center interventional randomized study. the aim of the study is to evaluate the post-operative recovery of the group a patient undergoing the partial knee replacement surgical procedure compared to the group b patient undergoing the total knee replacement surgical procedure through clinical/functional scores. the primary outcome is evaluate the difference in score of the kss questionnaire, at 1 month after surgery, completed by the patient of group a compared to the patient of group b. the population consists of 48 adult patients with gonarthrosis divided into two groups: 24 patients group a experimental group: partial denture surgical procedure 24 patients group b control group: total denture surgical procedure with patellar resurfacing

the medial unicompartmental prosthesis procedure associated with patellofemoral is reserved for active patients suffering from bicompartmental gonarthrosis in which total knee replacement is to be avoided. the advantage for the patient, compared to total prosthesis surgery, consists in the less invasive nature of the surgical gesture, in the total preservation of the cruciate ligaments and the external compartment and therefore of the native joint biomechanics with the possibility of remote revision with total prosthesis from first implant. patients keep "their knee" which is coated and not replaced with advantages in terms of joint feedback and functionality in daily activities and sports practices. this study aims to compare two groups of patients suffering from bicompartmental gonarthrosis (medial and patellofemoral gonarthrosis): group a undergoing a bicompartmental prosthesis surgical procedure; group b undergoing a total denture surgical procedure with patellar resurfacing. the two groups will be evaluated with clinical and functional scores aimed at evaluating the outcome in the two surgical procedures. the number and type of exams are as follows: * randomization to group a or group b (ad hoc) * knee replacement surgery (as usual) * compilation of kss questionnaire at 1, 2, 6, 12 months of follow-up with clinical and functional scores (as a matter of practice) * questionnaires and scales (womac, tegner, vas and patient satisfaction) at 2, 6, 12 months post intervention (as a matter of practice) * recording of any adverse events at 1, 2, 6, 12 months after surgery (as a matter of practice)

Eligibility criteria:
inclusion criteria: * grade 3-4 sec kellgren-lawrence medial gonarthrosis * patellar symptoms * primary gonarthrosis * patients with ligament integrity * age between 40 and 85 years inclusive * signing of the informed consent and consent to cooperate in all study procedures. exclusion criteria: * cognitive impairment * psychiatric disorders * neuromuscular disorders * age \> 85 years and \<40 years * lateral gonarthrosis grade 4 sec kellgren-lawrence * secondary medial gonarthrosis * revisions * minors * pregnant women self-declaration
minimal surgical treatment for obstructive sleep apnea (osa)

Conditions: Sleep Apnea Syndromes, Obstructive

Summary: obstructive sleep apnea carries a variety of complications and implications. while the disease could be treated using continuous positive airway pressure (cpap) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. the conventional surgical options to date ranges from radical (uppp) to individualized, with or without drug-induced sleep endoscopy (dise). previous studies showed that dise directed surgery can be useful for specific conditions. no trials were found to test in-office encompassing minimal invasive surgical treatment (rf palatoplasty , rf tonsillotomy, rf turbinectomy, and rf base-of-tongue reduction) as a viable alternative..


Eligibility criteria:
inclusion criteria: * patients suffering from osa, defined as ahi \> 5 exclusion criteria: * patients who can use cpap. * patients suffering from confounding factors with higher risk (coagulation problems, heart conditions, chronic obstructive pulmonary disease (copd), or other dangerous conditions as decided by the surgeon) * patients suffering from other problems aggravating the osa (respiratory, neurologic conditions)
phase 3 study of mrtx849 with cetuximab vs chemotherapy in patients with advanced colorectal cancer with kras g12c mutation (krystal-10)

Conditions: Advanced Colorectal Cancer; Metastatic Colorectal Cancer

Summary: study ca239-0006 is an open-label, randomized phase 3 clinical trial comparing the efficacy of mrtx849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with crc with kras g12c mutation.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of colorectal carcinoma with kras g12c mutation in tumor tissue. * prior receipt of 1st line treatment in advanced crc with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment. exclusion criteria: * prior treatment with a therapy targeting kras g12c mutation (e.g., amg 510). * prior treatment with an anti-egfr antibody (e.g., cetuximab or panitumumab). * active brain metastasis

Keywords: colorectal cancer colorectal cancer trial colorectal carcinoma rectal cancer colon cancer kras kras g12c ras colorectal adenocarcinoma
low-dose droperidol for prevention of postoperative delirium in elderly patients after non-cardiac surgery

Conditions: Digestive System Disease; Urologic Diseases; Gynecological Disease; Orthopedic Surgery

Summary: the aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on pod in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of pod and improving the prognosis and quality of life.


Eligibility criteria:
inclusion criteria: * age≥65 years * american society of anesthesiologists (asa): i-iii * planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery * estimated operation time more than 2 hours * not expected to be admitted to icu postoperatively * proficient in chinese * informed consent exclusion criteria: * morbid obesity with bmi \>35 kg/m2; * history of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, parkinson's disease, alzheimer's disease, myasthenia gravis, basal ganglia disease, etc; * corrected qt (qtc) of electrocardiogram\> 500ms; * preoperative liver insufficiency (child pugh grade c); * end-stage renal disease requiring dialysis; * severe heart failure \[metablic equivalent (mets)\<4\]; * allergic to droperidol; * inability to communicate due to coma or dementia in preoperative period; * preoperative delirium, assessed by 3d-cam; * more than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong chinese spirits); * participating in conflicting clinical trials; * expected to have an additional operation within 7 days after the index operation.

Keywords: non-cardiac surgery droperidol postoperative delirium elderly patients
intraoperative sedation and postoperative delirium

Conditions: Orthopedics

Summary: delirium are common after orthopedic surgery in the elderly and are directly associated with loss of independence, reduction in the quality of life and increased mortality. the cause of postoperative delirium still remains unclear and may be multifactorial. the aim of this retrospective study is to examine prevalence of postoperative delirium according to the use of dexmedetomidine or propofol in elderly patients undergoing orthopedic surgery under regional anesthesia.


Eligibility criteria:
inclusion criteria: * patients who underwent orthopedic surgery under regional anesthesia * age of 65 years or greater exclusion criteria: * general anesthesia * age \< 65 years * central nervous system disease, including dementia and parkinson's disease * patients who were not received sedation with propofol or dexmedetomidine during the operation
efficacy and safety of an ethanol/sodium citrate locking solution: a pilot study

Conditions: Catheter Related Infection; Bacteremia

Summary: currently in canada, either 4% sodium citrate or heparin 1,000-10,000 u/ml solutions are "locked" into hemodialysis catheters between dialysis sessions to prevent thrombosis. the use of an ethanol/sodium citrate locking solution may have advantages over either of these agents alone. the investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking solution is safe and effective in the prevention of catheter-related infections and thrombosis.

the pilot study will utilize a prospective, randomized design. after meeting the inclusion/exclusion criteria and providing written informed consent, patients will be randomly assigned to a 30 % ethanol/ 4% sodium citrate locking solution or heparin 1000 u/ml. patients will be enrolled from the health sciences centre and the sherbrook dialysis units in winnipeg, manitoba, canada.

Eligibility criteria:
inclusion criteria: * patients with stage v chronic kidney disease preparing to start hemodialysis * exchange of an existing catheter to a cuffed, tunneled catheter or planned vascular access with a cuffed, tunneled catheter * cvc used for hemodialysis made of alcohol-resistant polymers ie. carbothane exclusion criteria: * patients receiving catheters not made of alcohol resistant polymers * critically ill patients in icu setting * patients with acute renal failure, who will likely not require prolonged vascular access ( ie. \> months) * patients with maturing fistulas/graft creation within 2 months * patients with planned antibiotic treatment courses lasting longer than 4 weeks from the date of new catheter insertion * patients receiving a new cuffed, tunneled catheter over a guide wire, if a fibrin sheath angioplasty was not performed after removing the previous dysfunctional catheter

Keywords: catheter related infection bacteremia hemodialysis
studies of the immune response in normal subjects and patients with disorders of the immune system

Conditions: Immunologic Deficiency Syndromes; Neoplasms

Summary: the goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. in vitro assays and in vivo skin tests and immunization with antigens will be utilized.

the goal of the protocol is to define the normal humoral and cellular immune responses to antigens in volunteers and to define abnormalities of these immune responses in patients with immunodeficiency diseases or cancer. in vitro assays and in vivo skin tests and immunization with antigens will be utilized.

Eligibility criteria:
patients will be studied if a disorder of the immune system is suspected.

Keywords: cellular immunity humoral immunity immunodeficiency disease
dpp-iv inhibition prior to development of diabetes in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis related diabetes (cfrd) is a common co-morbidity in patients with cf. the underlying pathophysiology of cystic fibrosis related diabetes (cfrd) is still a matter of investigation. in addition to localized tissue damage developing similar to that of the exocrine pancreas, other mechanisms may be involved. we have shown that a potential contributing factor to the patho-physiology of cfrd may be an abnormal gut derived hormonal profile, specifically of lower incretin hormone responses, prior to development of cfrd. we propose that an altered incretin response, probably due to impaired interaction of nutrients with the gut mucosa due to thickened secretions, may play a role in the development of the disease. specifically, low gip and glp-1, may explain the poor β-cell function observed in these patients prior to cfrd appearance. these incretins have known trophic effects on β-cells, and thus their lower levels may contribute to the development of quantitative as well as qualitative defects in β-cell function and thus may lead to the development of cfrd. thus, increasing levels of these incretins using a dpp-iv inhibitor may improve glucose metabolism and delay/prevent the development of cfrd. we hypothesize that saxagliptin will increase the odi compared to placebo and will thus provide relative protection from diabetes development and in addition we expect that saxagliptin will lead to overall increased insulin concentrations and thus shift the metabolic milieu to a more anabolic state. this will manifest as weight gain and reduction in inflammation.

the following proposal includes testing the utility of dpp-iv inhibition in adult patients with cf without cfrd. this will be achieved by a randomized double blind controlled trial of saxagliptin 5 mg vs. placebo which will be performed for 3 months in 60 patients with cf without cfrd. the study will be for 3 months of use and will consist of two arms: 1. saxagliptin 5mg 2. placebo. the primary outcome of this study will be the oral disposition index odi , derived from the ogtt. the odi has been shown across age groups and metabolic phenotypes to be an excellent predictor of diabetes development over time . we postulate that saxagliptin will increase incretin concentrations and thus improve insulin secretion. this will manifest as an increased oral disposition index (odi), reflecting an improved beta cell response in the context of prevailing insulin sensitivity. the odi is a useful predictor of diabetes development over time and its increase will provide evidence for protection from diabetes in this special study population

Eligibility criteria:
inclusion criteria: * age greater than 18 years * diagnosis of cf * no cfrd on baseline ogtt * normal kidney function * no history of pancreatitis * able and willing to consent and participate exclusion criteria: * acute illness/exacerbation of cf associated lung disease * receiving immune-modulators following lung/pancreas transplant