Kornimate/medical-research-clean huggingface dataset:
role of aliskiren, a direct renin inhibitor, in preventing atrial fibrillation in patients with a pacemaker; ralf.

Conditions: Atrial Fibrillation

Summary: the aim of the study is to find out whether aliskiren reduces atrial fibrillation burden measured with a pacemaker device

the aim of the study is to find out the effect of a direct renin inhibitor, aliskiren, in reduction of af with patients who have a pacemaker due to sinus node disease and paroxysmal atrial fibrillation. hypothesis is that there is a possibility to reduce atrial remodeling due to af and also to enhance atrial reverse remodeling with aliskiren. the effect of aliskiren to total af burden will be evaluated from the pacemaker's memory storage. the main purpose of the study is to find new and safe drug treatments targeting to reduce af recurrences and related complications in pacemaker patients. also the aim is to evaluate the feasibility of a modern and highly sophisticated pacemaker system in the evaluation of drug treatment with af reduction.

Eligibility criteria:
inclusion criteria: * age between 18 and 85 years * sinus node disease and paroxysmal af * provided signed informed consent according to the declaration of helsinki for study participation * a previously implanted st. jude medical identity / victory / zephyr adx or any newer model of sjm dddr pacemaker with ability to record high atrial rates exclusion criteria: * contraindication for the use of aliskiren * severe impairment of renal function (serum creatinine \> 160 µmol/l) or patient with solitary kidney or renal transplant or renal artery stenosis * significant known aortic or mitral valve stenosis or obstructive hypertrophic cardiomyopathy * hypersensitivity to aliskiren or to any of the excipients * concomitant treatment with cyclosporine * patients with uncontrolled hypertension requiring treatment for hypertension * systolic blood pressure measured in two separate occasions ≥ 160 mmhg * diastolic blood pressure in two separate occasions ≥ 100 mmhg * absolute indication for the use of an raas blocker * chronic, persisting af (persisting af at screening with ≥ 4 cardioversions performed beforehand) * sitting systolic arterial blood pressure of less than 100 mm hg at the time of randomisation * need for ventricular pacing more than 30% at the enrolment * pregnancy and/or lactation * women of childbearing potential (only postmenopausal women or women after tubal ligation will be allowed) * other serious disease expected to cause substantial deterioration of patient's health during the next two years * past or present alcohol or drug abuse * participation in other clinical trials during the last three months * suspicion of poor study compliance
treatment of biliary obstruction using biliary stent with or without antireflux valve

Conditions: Biliary Obstruction; Cholangitis

Summary: biliary obstruction can be relieved by biliary stent. ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. stents with antireflux valves are designed to reduce the reflux from the bowel. the purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.


Eligibility criteria:
inclusion criteria: * age 18-89 * biliary obstruction in the lower two thirds of the choledochus exclusion criteria: * allergy to contrast media * future pancreaticoduodenectomy * refusal from the study * previous stent

Keywords: antireflux valve biliary obstruction cholangitis biliary stent
evaluating the cologuard test for use in lynch syndrome

Conditions: Lynch Syndrome; Colorectal Cancer; Colonic Adenoma; Colonic Polyp

Summary: this study is aiming to enroll 90 patients with genetically confirmed lynch syndrome (ls) from geisinger's high risk colorectal cancer clinic (hrc). upon enrollment in the study, a cologuard test will be ordered and the results will be blinded until data analysis. patients enrolled in the study will also undergo a colonoscopy as part of their routine hrc visit.

the primary aim is to perform a pilot study to gain information toward the implementation of a larger prospective study that will compare the performance of cologuard with the gold-standard colonoscopy in identifying advanced adenomas and colorectal cancers in ls. data regarding rate of consent, and adherence to the protocol will be recorded. since patients with known genetic predisposition to cancers tend to view screening tests more positively than the general population, a second aim of the study is to evaluate patient satisfaction with bowel preparation, colonoscopies, and cologuard testing. up to 90 individuals with genetically confirmed ls will be recruited via geisinger's hrc to complete a goal of 90 cologuard studies. upon enrollment, cologuard will be ordered by the study team at no cost to the subject and will be completed according to the standard instructions for use. results will be securely obtained and blinded until the time of data analysis. subjects will undergo colonoscopy as part of their routine hrc visit. results from the colonoscopy (and biopsy as indicated) will be retrieved from the electronic health record (ehr) and documented in a research-associated spreadsheet. if repeat colonoscopy is clinically indicated, repeat cologuard may be completed if the subject meets inclusion criteria.

Eligibility criteria:
inclusion criteria: * patients age 18-89 * diagnosis of genetically confirmed ls * scheduled for standard of care colonoscopy within 60 days of enrollment exclusion criteria: * diagnosis of other inherited genetic disorders that increase risk for colorectal cancer (crc) (familial adenomatous polyposis (fap), cowden's syndrome, turcot syndrome, gardner syndrome, and peutz-jeghers syndrome) * diagnosis of other inherited inflammatory bowel disease (i.e. crohn disease, ulcerative colitis) * others with elevated risk of crc outside of the inclusion criteria (i.e. ≥2 first-degree relatives who have been diagnosed with crc without a defined inherited genetic disorder, hereditary non-polyposis colon cancer (hnpcc) without genetic confirmation of ls) * participation in any interventional clinical study within the previous 30 days * personal history of crc not in full remission (5 consecutive cancer-free years) * current active treatment with chemotherapy * treatment with chemotherapy within 12 months prior to consent date

Keywords: lynch syndrome colorectal cancer hereditary non-polyposis colon cancer high-risk colon cancer health-related quality of life bowel prep tolerability colonoscopy procedural anxiety
task focusing strategy during a simulated cardiopulmonary resuscitation

Conditions: Mental Stress

Summary: this is a prospective randomized controlled study. the aim of this study is to 1. describe the stress patterns experienced during a cpr situation; 2. investigate whether the perceived stress was associated with cpr performance in terms of hands-on time and time to start cpr; 3. to investigate whether this task focusing strategy reduces perceived stress levels, and 4. whether this translates into better cpr performance. based on findings that clear, directive leadership can enhance performance in cardiac resuscitation, we further 5) investigate if stress was associated with fewer leadership statements.


Eligibility criteria:
inclusion criteria: * 4th year medical students exclusion criteria: * no informed consent

Keywords: cardiopulmonary resuscitation stress intervention
hip pocus for the diagnosis of pediatric hip effusion.

Conditions: Hip Effusion

Summary: limping is a common complaint among children presenting in the pediatric ed the evaluation of a limp among infants and toddlers is challenging doe to the lack of specific history and the difficulty in locating the pain - therefore hip sonography is frequently used in the clinical evaluation of these children. sonographic examination for the diagnosis of hip effusion is routinely performed by the radiologist, however, since the integration of point of care ultrasound (pocus) as part of the clinical evaluation of children in the ed in many application - hip pocus is frequently performed by pediatric emergency medicine physicians. the existing data on hip pocus is scarce and comprised of small uncontrolled studies. we aimed to examine the specificity and sensitivity of hip pocus performed by pediatric emergency physicians by comparing it to the scan performed by the radiologist. the primary outcome measurement is the ability of the pocus exam to identify or rule out the existence of hip effusion as demonstrated in the formal radiological ultrasound scan.

children (0-18 years) presenting to the ped in meir medical center with limp pain (not due to trauma) or a limp are recruited after consenting to participate in the study and completing the registration process the primary physician who is an approved researcher by the institutes irb will perform hip pocus as part of the clinical evaluation and will record his interpretation in the medical file. a formal ultrasound scan will be perfumed additionally by the radiologist. both examination will be reviewed by pocus lead physician and the pediatric radiologist. the patient's clinical and epidemiological data will be extracted from the electronic chart.

Eligibility criteria:
inclusion criteria: pediatric patients presenting to the ped with the complaint of a limp or a lower limb pain - exclusion criteria: * trauma patients * patients with an obvious diagnosis other than pain resulting from the hip joint on their physical examination.

Keywords: hip effusion, point of care sonography, pediatric,
the effect of monitoring pvp on clinical outcomes in patients with ph

Conditions: Portal Hypertension

Summary: the complications associated with portal hypertension in cirrhosis are the main cause of death in patients with cirrhosis. the level of portal venous pressure is closely related to the prognosis of patients. hvpg (hepatic venous pressure gradient) is the "gold standard" for predicting portal venous pressure and an important indicator for evaluating the efficacy of nsbbs. however, monitoring hvpg has many limitations，and the clinical application is also limited to a certain extent. therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. therefore, this study intends to clarify the guiding value of monitoring portal venous pressure in the clinical diagnosis and treatment of portal hypertension patients through a single-center, prospective and observational study. at the same time, to explore the correlation between hvpg and ppg in cirrhosis patients at different stages and different etiologies, and to evaluate the role of spleen stiffness in predicting the severity of esophageal and gastric varices in patients with portal hypertension, and to find biomarkers to predict the risk of complications related to portal hypertension.


Eligibility criteria:
inclusion criteria: * with chronic liver disease * age 18-80 years * patients who require a portal pressure measurement at the discretion of the treating physician * voluntarily signed informed consent exclusion criteria: * with serious cardiopulmonary disease or other diseases affect survival * with severe renal dysfunction * concomitant portal vein cavernous degeneration or extensive portal vein thrombosis * women who are planning to become pregnant or who are pregnant or breastfeeding * the researcher judged that it was not suitable to participate in this study
the safety and effect study of acupuncture for anorexia in patients with gastrointestinal tract and lung cancers

Conditions: Anorexia; Cancer Cachexia

Summary: this trail will be carried out to evaluated the effect and safety of acupuncture for the anorexia in patients with gastrointestinal tract and lung cancers.

acupuncture used for anorexia related to cancer, but there were lack of powerful evidence. the 160 eligibilities will be randomly divided into 3 groups(acupuncture and placebo group, megestrol acetate and sham acupuncture group, placebo and sham acupuncture group).the effect will be investigated baseline, the 2,5,8 and 15days. the safety issue will be recorded every section during the acupuncture.

Eligibility criteria:
inclusion criteria: 1. diagnosed gastrointestinal tand lung cancers; 2. age ≥18 years; 3. appetite score≤ 6 (0= worst appetite), and the symptom lasted 2 weeks at lest at screening; 4. had a history of weight loss ≥5% within 6 moths; 5. maintained oral intake; 6. signed the informed consent. exclusion criteria: 1. patients with dementia, delirium, intestinal obstruction, pregnancy or lactation; 2. had uncontrolled symptoms that could impact appetite or caloric intake such as nausea, pain, or depression(the score of the symptoms≤ 3, 0= worst) ; 3. patients with untreated vitamin b12 deficiency or endocrine abnormalities(thyroid dysfunction and hypoadrenalism); 4. patients on melatonin supplements or medications with potential appetite-stimulating activity(chinese herb,thalidomide) 5. less than one week before the screening or there will be a surgery ,radiotherapy and chemotherapy the acupuncture; 6. lifetime expected less than 3 months.

Keywords: cancer anorexia cachexia syndrome acupuncture megestrol acetate poor appetite anorexia randomized controlled trial
impact of the use of a closed-loop insulin therapy on the burden of the diabetes and the quality of life

Conditions: Quality of Life; Burden, Dependency

Summary: the use by diabetes patients of real-time continuous glucose monitoring (cgm) system is becoming widespread and has changed diabetic practice. automated closed-loop (cl) insulin therapy has come of age. this major technological advance is expected to significantly improve the quality of care for adults, adolescents and children with type 1 diabetes. questions remain about patients' perception and acceptance on this automatisation of the management of their glycemic variability. thus this study is built to evaluate the impact of the activation of the closed-loop on quality of life and burden of their diabetes in patients with type 1 diabetes under csii.

this cohort study will follow patients with type 1 diabetes undergoing under continuous subcutaneous insulin infusion (csii) with continuous glucose monitoring (gcm). after inclusion visit, there's a 20 days' period to assess their quality of life and perception of the burden of their diabetes and confirm their eligibility to the closer-loop. during this 20 days' period, patients should complete all the self-questionnaires. then, during the 2d visit, the closed-loop will be activated by the diabetologist for a 6 months follow-up including six visits with 3 phone contacts (at week 1, week 2 and week 6) then 2 direct visits at 3 months and 6 months. the 3 phone contacts are mainly planned, as recommended in french guidelines, to ensure the good use of the device and to detect or prevent any unexpected events. the 2 visits at 3 and 6 months, are planned to assess the glycemic variability using continuous glucose monitoring data and to collect perception of the patients via the 2 main criteria self questionnaires (quality of life and burden to be filled-in by patients at 3 and 6 months) and all perception dimensions by all the self questionnaires. main results will provide data on the evolution of quality of life and burden of diabetes by comparison between scores at 6 months and baseline, and evolution of glycemic variability.

Eligibility criteria:
inclusion criteria: * type 1 diabetic patients undergoing a csii therapy for at least 6 months and using tandem t:slim x2 for at least 4 weeks. * patient using cgm for 6 months including dexcon g6 for at least 4 weeks. * eligible patient (according to french society recommendations) for activation of the closed loop * informed patient accepting the computer processing of their medical data. * patient correctly completing the 2 main self questionnaires * patient with hba1c below 11% exclusion criteria: * pregnancy or lactation during the study * patient with a diabetic retinopathy not controlled by laser * patient suffering from a disease or undertaking a treatment altering glucose metabolism

Keywords: continuous subcutaneous insulin infusion diabetes type 1 closed loop
pharmacokinetic study of solamargine in patients with actinic keratosis

Conditions: Actinic Keratosis

Summary: this study is designed to evaluate the pharmacokinetics of solamargine of sr-t100 gel. as safety parameters, adverse events, and vital signs (blood pressure, heart rate, and body temperature) will be recorded.

in the study period, a single dose of 2 g topical sr-t100 gel (containing 2.3% solamargine in solanum undatum plant extract) in 100 cm2 skin area covered by an occlusive dressing will be administered. sampling time schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 20, 24, 36 hours after dosing.

Eligibility criteria:
inclusion criteria: 1. male or female is 20 years of age or above. 2. patient has ak lesions located within a 100 cm2 contiguous or non-contiguous treatment area. 3. patient has at least one clinical confirmed ak lesion within the selected treatment area before. exclusion criteria: 1. patient had used the following treatments within 4 weeks prior to the study treatment initiation: immunomodulators or immunosuppressive therapy, interferon, cytotoxic drugs. 2. patient had treated with topical 5-fu, diclofenac gel, imiquimod, ingenol mebutate, corticosteroids, retinoids, masoprocol on the treatment area within 4 weeks prior to the study treatment initiation. 3. patient had received cryodestruction, chemodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks prior to the study treatment initiation. 4. patient had received any of the following treatments on the treatment area in the 6 months before study treatment initiation: psoralen plus uva therapy, uvb therapy, laser abrasion, dermabrasion, chemical peel. 5. patient had used any topical preparations, such as sunscreens, moisturizers, body oils, or alpha or beta hydroxyl acids, in the treatment area within 24 hours before and during the study course. 6. use of any medication, including over the counter products, herb medicine and dietary supplements such as vitamins, which would interfere with study results, within one week before and during the study course. 7. patient is known to be hypersensitive to the study medication. 8. female who is pregnant, breast-feeding or considering becoming pregnant while on the study. 9. donation of 500 ml of blood in the past 3 months prior to dosing or donation of 250 ml of blood in the past 2 months prior to dosing. 10. patient had used of any investigational drug within the past 30 days before enrollment. 11. patient has any dermatological disease and/or condition, such as atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, melanoma, or other possible confounding skin conditions in the treatment or surrounding area (5 cm distances from treatment area).

Keywords: actinic keratosis sr-t100 pharmacokinetics
tranexamic acid in reducing blood loss in patients with pelvic tumors undergoing hemipelvectomy surgery

Conditions: Pelvic Mass

Summary: this early phase i trial studies how well tranexamic acid works in reducing the loss of blood in patients with pelvic tumors undergoing hemipelvectomy surgery. tranexamic acid decreases blood loss by stabilizing clots and preventing clot lysis in patients undergoing surgery.

primary objectives: i. to determine if the use of tranexamic acid results in a significant reduction in intraoperative and perioperative blood loss. secondary objectives: i. to determine if use of tranexamic acid lowers the amount of blood products transfused in hemipelvectomy surgeries and during first postoperative week. ii. to determine if the use of tranexamic acid has an effect on laboratory (lab) measurements preoperatively through postoperative day 7. iii. to determine if use of tranexamic acid has an effect on complication, length of intensive care unit (icu), and hospital stays. outline: patients are randomized to 1 of 2 arms. arm i (tranexamic acid): patients receive tranexamic acid intravenously (iv) over 15 minutes 30 minutes prior to surgery and continuously during hemipelvectomy procedure in the absence of disease progression or unacceptable toxicity. arm ii (no tranexamic acid): patients undergo standard of care hemipelvectomy in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up at 7 days.

Eligibility criteria:
inclusion criteria: * both pediatric and adult patients can be eligible to participate * cognitively impaired and non-english speakers can be eligible to participate. * both male and female patients must have a pelvic tumor and are scheduled to have surgery at university of texas (ut) monroe dunaway (md) anderson cancer center that require hemipelvectomy, resulting in pelvic ring disruption exclusion criteria: * patient with a history of genetic prothrombotic state * patient with a history of thromboembolic disease to include pulmonary embolus or other extremity deep venous thrombosis * patients with thrombosis of the planned site of resection will not be excluded if the thrombus is caused directly by tumor burden or outflow obstruction * female patients will not be eligible for this study if she is either pregnant or nursing at the time of enrollment * patients will not be eligible if they have a history of color vision defects * patients will not be eligible if they have a history of retinal vein or artery occlusion * patients will not be eligible if they have a history of intracranial hemorrhage in past 6 months * patients will not be eligible if they have a history of hypersensitivity to tranexamic acid * patients will not be eligible if they present with moderate to severe decrease in creatinine clearance (estimated glomerular filtration rate \[egfr\] \< 45 ml/min/1.73m2) * patients will not be eligible if they present or have a history of seizure disorder
study to assess the efficacy, safety, and tolerability of avp-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury

Conditions: Neurobehavioral Disinhibition

Summary: this is a multicenter, randomized, placebo-controlled study to evaluate avp-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (tbi).

eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression, agitation, and irritability that persists after brain injury. this is a multicenter, randomized, placebo-controlled study, consisting of up to 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * participants with tbi * participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness * score of ≥4 on the mcgi-s scale and the agitation/aggression or irritability/lability subscales of the neuropsychiatric inventory (npi) scale at screening and baseline * participants with a reliable caregiver exclusion criteria: * participants with significant symptoms of a major depressive disorder * participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder

Keywords: aggression agitation irritability non-penetrating brain injury traumatic brain injury tbi avp-786