Kornimate/medical-research-clean huggingface dataset:
prefistula forearm exercise in pts requiring chronic hd therapy

Conditions: Arterio-venous Fistula; Kidney Failure; Hemodialysis Access Failure

Summary: for chronic hemodialysis patients, the creation of a well-functioning arteriovenous (av) fistula is critical for ensuring that patient receive adequate hemodialysis. unfortunately, the primary failure rate for av fistulas after surgery is about 40%, and this percentage has not changed despite a number of trials of pharmaceutical agents and biologic agents. a key to success in the development of a useable av fistula is an adequate arterial and venous diameter in the access forearm. although exercise is commonly used to increase vessel diameter after av fistula placement, investigators are unaware of published studies that report on the effect of exercise prior to av fistula placement to assist with the maturation of a newly created av fistula. in this pilot trial, the principal investigator will evaluate the feasibility and possible benefits of pre-surgical exercise on forearm av fistulas.

the trial is designed to determine if a pre-surgical exercise program will improve the likelihood of a useable forearm av fistula. in this pilot study, the feasibility of the proposed intervention will be assessed in terms of both patient acceptability and patient outcomes. in addition, results from this feasibility study will be used to help determine power calculations for a full-scale trial. patients will be eligible for this pilot clinical trial if scheduled for placement of an elective forearm av fistula for chronic hemodialysis access. patients will be randomized using a random number generator to either the intervention or the control group. the intervention group will be instructed in the use of hand grip with built in digital counter. these instructions will include the use of the hand grip on a daily basis with an increasing number of hand grip squeezes to be performed each week up until the time of fistula placement. patients in the control group will not receive any pre-surgical instructions for exercise in the access arm. in both groups, patients will be provided with post-surgical instructions on the use of a squeeze ball on a daily basis once the steri-strips from the surgical site have fallen off.

Eligibility criteria:
inclusion criteria: * scheduled for placement of an elective forearm av fistula for chronic hemodialysis access. exclusion criteria: * the presence of joint or musculoskeletal impairments that prevent the patient from using a handgrip device on a daily basis

Keywords: hemodialysis fistula access failure hemodialysis fistula creation
an early stage study to evaluate oba01 for injection in patients with dr5 positive la/mnsclc

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: this study will evaluate the safety, tolerability, pharmacokinetics and efficacy of oba01 for injection in patients with dr5 positive la/mnsclc.


Eligibility criteria:
inclusion criteria: * voluntary agreement to provide written informed consent. * man or woman ≥ 18 years and ≤75 years of age at the time of enrollment. * histologically and/or cytologically-confirmed locally advanced or metastatic nsclc. * measurable lesion according to recist 1.1. * progression after systemic treatment for advanced nsclc. * available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * measurable and/or non-measurable disease as per recist 1.1 criteria. * adequate organ function as assessed by laboratory tests. * male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment. exclusion criteria: * patient has received previous treatment with dr5 targeted regimen or antibody-mmae conjugate. * brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment. * subject with positive hcv-ab, anti-hiv or positive hbs-ag with copies of hbv dna \> uln. * pregnancy, lactation, or breastfeeding.
changes in aviators' body core temperature measurements at f-35

Conditions: Aviation; Heat Stress

Summary: the many complaints that have been expressed by the us aircrew of the f-35 regarding the heat stress in the cockpit raised an obvious concern that, as a result of such heat levels, the aviators' core body temperature may increase significantly, and subsequently cause severe cognitive impairment- risking both the pilot and the mission. in order to validate this hypothesis, we will measure the aviators' core body temperatures while inside the cockpit of the f-35, to see whether their core body temperatures are rising to a level that can cause heat stress or not. the temperatures will be measured on another fourth generation aircraft as well for comparing purposes. the temperatures will be measured using a telemetric pill which will be ingested by each aviator. once ingested, the pill will transmit the data to an external monitor. the collected data will be examined and analyzed in order to determine the likelihood of heat stress occurrence.


Eligibility criteria:
inclusion criteria: * f35 pilots * signing on informed consent exclusion criteria: * sickness two weeks prior the experiment

Keywords: heat stress, pilots
deep-learning image reconstruction in ccta

Conditions: Coronary Artery Disease

Summary: cardiac ct allows the assessment of the heart and of the coronary arteries by use of ionising radiation. although radiation exposure was significantly reduced in recent years, further decrease in radiation exposure is limited by increased image noise and deterioration in image quality. recent evidence suggests that further technological refinements with artificial intelligence allows improved post-processing of images with reduction of image noise. the present study aims at assessing the potential of a deep-learning image reconstruction algorithm in a clinical setting. specifically, after a standard clinical scan, patients are scanned with lower radiation exposure and reconstructed with the dlir algorithm. this interventional scan is then compared to the standard clinical scan.


Eligibility criteria:
inclusion criteria: * patients referred for cardiac ct angiography * age ≥ 18 years * written informed consent exclusion criteria: * pregnancy or breast-feeding * enrollment of the investigator, his/her family members, employees and other dependent persons * renal insufficiency (gfr below 35 ml/min/1.73 m²)
perioperative ostomy self-management telehealth for cancer patients and family caregivers

Conditions: Malignant Neoplasm

Summary: this phase ii trial studies how well perioperative ostomy self-management telehealth (periop-osmt) provides patients and their caregivers information about ostomy and ostomy care. periop-osmt may help to understand patient preparedness to do ostomy self-care, confidence in doing ostomy self-care, knowledge of ostomy self-care, quality of life, mood, use of medical services, and financial burden.

primary objective: i. assess the feasibility and acceptability of the periop-osmt as measured by the percentage of patients and support persons/family caregivers (fcgs) who agree to participate; complete \>= 80% of the intervention; and report satisfaction with the intervention (through structured exit interviews). secondary objectives: i. examine the patterns and trajectories for patient outcomes pre- and post-intervention, including patient activation, self-efficacy, ostomy-related knowledge, health related quality of life (hrqol), medical care utilization, and financial burden. ii. examine patterns and trajectories for support person/fcg outcomes pre- and post-intervention, including quality of life (qol). iii. using qualitative methods, evaluate the acceptability of the intervention as reported by participants. outline: patients and/or support persons/family caregivers complete periop-osmt session in-person or via telephone over 20-40 minutes before surgery and before hospital discharge, and group telehealth session over 1.5-2 hours at weeks 1-3, 4, 5, 6, and 7 post discharge. after completion of study intervention, participants are followed up for 6 months.

Eligibility criteria:
inclusion criteria: * patient: scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary). * patient: able to read and understand english. * patient: patients scheduled for temporary ostomy procedures * support person/fcg: family member/friend identified by the patient as the primary caregiver before and after surgery. * support person/fcg: able to read and understand english. * patients with all stages of disease are eligible for the study. * the study is open to anyone regardless of gender or ethnicity. efforts are made to extend the accrual to a representative population. exclusion criteria: * subjects, who in the opinion of the principal investigator (pi), may not be able to comply with the requirements of the study.
transcranial direct current stimulation on post stroke depression

Conditions: Post-stroke Depression

Summary: the aim of the research is to address the critical gap that limited number of rcts are conducted on this topic. to further explore the efficacy of tdcs, large sample sizes, large follow up period and rigorously controlled randomized clinical trials are necessary. an optimum stimulation protocol is also needed on this study. previous studies lack information regarding effects of this stimulation on depression, cognition, quality of life in relation to different severity levels of stroke.

research studies revealed that psd causes both cognitive and physical impairments to lower motivation, which hinders rehabilitation program participation and slows down executive functions. due to depression, cognitive dysfunctions difficulty in executive, working memory and emotional deficits which declines quality of life (qol). thus, the combined effects of cognitive decline and psd considerably more worsen stroke survivors' qol with regard to psychological, environmental and physical well-being evidence supports various techniques for minimizing psd, restoring cognitive function, and enhancing qol including mindfulness-based therapies, exercise therapy (aerobic and resistance trainings), progressive muscle relaxation exercises, cognitive behavioral therapy (cbt). non-invasive brain stimulation (nibs) include transcranial direct current stimulations (tdcs) demonstrated significant therapeutic outcomes in the psd rehabilitation.

Eligibility criteria:
inclusion criteria: * stroke for more than 6 months both gender with equal ratio on stroke severity basis depression diagnosed by psychiatrist mild and moderate depression at phq-9 national institutes of health stroke scale (nihss) for severity level; mild (1-4), moderate (5-15), moderate to severe (16-20), severe (21-42) exclusion criteria: * any medical condition like cardiac arrhythmias, uncontrolled hypertension. individual with any pacemaker and metal implant in body. patient with any other neurological and psychiatric condition.

Keywords: stroke depression transcranial direct current stimulation
the effect of adalimumab on the bone microstructure in crohn's disease (cd) patients

Conditions: Crohn's Disease

Summary: the investigators will study the effect of adalimumab on the bone microstructure. * trial with medicinal product


Eligibility criteria:
inclusion criteria: * cdai \> 220 und \< 450 * biologika naiv * cd seit \> 6 monaten exclusion criteria: * other tnf-blocker * steroids \> 40 mg * malignoma in der anamnesis
preventing propofol injection pain: prospective randomized trial comparing propofol versus fospropofol

Conditions: Complication of Injection; Pain

Summary: the purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).

propofol (2,6-diisopropylphenol) is one of the most common induction and sedative agents used today. properties that make this agent popular include rapid onset and quick recovery. however, as its use became more widespread, side effects such as pain on injection have attracted more attention. the incidence of pain on propofol injection is as high as 70 - 90%. numerous studies report that more than 50% of patients recall the unpleasant burning sensation during injection. many techniques to minimize pain on injection associated with propofol have been described; pre-administration of different medications including lidocaine, ketamine, thiopental, metoclopramide, dexamethasone, ondansetron, and remifentanil have been reported with mixed success. some have even tried to use lidocaine with a tourniquet. others have reported the use of distraction techniques including counting numbers aloud. recently, a solvent mixture of medium chain triglyceride and long chain triglyceride has been tested for prevention of pain on propofol injection. lusedra (fospropofol disodium), the water-soluble prodrug of propofol, does not cause pain on injection as it is water based medication. demonstrating the benefit of fospropofol over propofol in patient satisfaction will improve acceptance by anesthesia providers.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i, ii or iii. * age 18 - 65. * both male and female. * no significant laboratory abnormalities. exclusion criteria: * chronic pain patients or patients receiving benzodiazepines or opioids / other analgesics for control of acute pain will be excluded. * patients with known allergies to any of the study drugs, or to soybean oil or egg lecithin are excluded. * women with a positive pregnancy test reported from pre-surgical testing or their physician's office or who are breast feeding at the time of surgery. * no emergency patients will be recruited for this study.

Keywords: fospropofol propofol colonoscopy lusedra
the prevalence of chronic rhinosinusitis associated with inflammatory bowel disease and association with biomarkers of epithelial barrier damage

Conditions: Intestinal Inflammation; Rhinosinusitis

Summary: the goal of this observational study is to define the prevalence of chronic rhinosinusitis in patients with intestinal bowel disease. the main questions it aims to answer are: * evaluate the influence of chronic rhinosinusitis on the quality of life of patients with intestinal bowel disease * evaluate any relationships between chronic rhinosinusitis and the clinical course of intestinal bowel disease -evaluate the influence of chronic rhinosinusitis on the response to biologic therapies for intestinal bowel disease * evaluate mucosal barrier damage in patients with chronic rhinosinusitis and intestinal bowel disease by collecting blood and stool samples according to clinical practice * presence of enterotoxin sensitization to s. aureus in patients with intestinal bowel disease * histopathological evaluation: reevaluation of biopsy slides performed according to clinical practice will be performed in patients with chronic rhinosinusitis and intestinal bowel disease in order to quantify the proportion of eosinophilic infiltrate at the intestinal level and to assess any differences from the population with intestinal bowel disease only. patients with intestinal bowel disease afferent to our outpatient chronic inflammatory bowel disease clinic at cemad will be enrolled.


Eligibility criteria:
eligibility criteria inclusion criteria: * age between 18 years and 70 years. * diagnosis of crohn's disease or ulcerative rectocolitis * willingness to participate in the study and ability to comply with and understand the study protocol. * patients with a previous diagnosis of crohn's disease or ulcerative rectocolitis for at least 3 months prior to screening * signature of informed consent exclusion criteria: * age \<18 years * refusal of informed consent
genetic and environmental determinants of hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to determine the pathophysiology of different types of essential hypertension by identifying the discrete effects of major genes and environmental variables as determinants of the subtypes of essential hypertension.

background: essential hypertension is believed to be a heterogeneous group of disorders, the subtypes of which could be related to sodium sensitivity, obesity, diabetes, calcium intake and metabolism, the renin-angiotensin balance, or membrane cation transport. essential hypertension aggregates in families. the syndromes leading to hypertension may involve shared genes, shared environmental factors, or both. design narrative: in 1980 a series of biochemical and physiological tests were initiated in the 2,548 persons in 98 extended pedigrees in utah. most of the subjects were obtained from three major pedigree types: stroke cluster pedigrees; coronary heart disease cluster pedigrees; and pedigrees of utah hypertension detection and follow-up program high blood pressure probands. data were collected on personal history, medical family history and genealogy, anthropometrics, standard and 32-lead electro- cardiograms, multiple blood pressure measurements during sitting, standing, lying, tilting, isometric hand grip exercise, bicycle exercise, venipuncture and mental arithmetic. cation tests included sodium-lithium countertransport, lithium-potassium co-transport, intracellular sodium, potassium, magnesium, sodium-potassium atp-ase pump activity and binding sites and plasma levels of sodium, potassium, magnesium, ionized calcium and digoxin-like pump inhibitor. information was also collected on stress, exercise, plasma renin activity, and urinary kallikrein. statistical and pedigree analysis were conducted. the same tests were also performed on 600 new population-based hypertensive subjects on drug therapy and again four months after interruption of drug therapy. tests were conduced for specific subtypes of high blood pressure among the 600 subjects using individual variables and multivariate combinations of variables. three hundred nuclear families were screened to test for familiality of subtype indicators and to identify those high blood pressure subtype indicator variables needing detailed pedigree analysis. one thousand sequentially-sampled persons were studied for major genes, dna probe linkage, and gene-environment interactions as determinants of specific types of hypertension.

Eligibility criteria:
no eligibility criteria
use of hyperpolarized xenon gas for lung imaging in children and adults

Conditions: Respiratory Disorders

Summary: the goal of this study is to evaluate the usefulness of hyperpolarized (hp) 129xe (xenon) gas mri for regional assessment of lung function in a normal population of children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.

hyperpolarized 129xe will be produced, by trained staff, using a polarizer housed at cincinnati children's hospital medical center. individual imaging sessions will be done on a single day and will involve administration of (maximum) 1 liter doses (less for children) for up to four mri scans. subject will inhale hyperpolarized xenon gas and hold breath for up to 16 seconds during the mri scans. in addition to 129 xe mri, a series of anatomical conventional proton mr images may also be collected. follow up phone calls will be done one day and 30 days from the mri date.

Eligibility criteria:
inclusion criteria: * ages 6 and up * participant must be able to hold breath for up to 16 seconds exclusion criteria: * history of heart defect * pregnancy or positive pregnancy test * history of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month * symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week * baseline oximetry at mri visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula * participant is claustrophobic and unable to tolerate the imaging. * standard mri exclusions (metal, implants)

Keywords: respiratory
delivery of self training and education for stressful situations-telephone version

Conditions: PTSD

Summary: this study will evaluate a telephone-delivered cognitive-behavioral psychotherapy intervention designed for primary care treatment of combat-exposed service members with ptsd. the investigators will assess posttraumatic stress disorder (ptsd) symptoms, mental health-related and occupational functioning, and symptoms of depression, anxiety, and somatization.

this is a randomized controlled trial that will compare destress-t to optimized usual care (ouc). optimized usual care is usual primary care ptsd treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider (pcp), and care coordination.

Eligibility criteria:
inclusion criteria: * age\>18 years * dsm-iv diagnosis of ptsd (derived from the caps) due to combat in oif/oef deployment * active duty personnel exclusion criteria: * active suicidal or violent ideation within the past two months as assessed by the mini and a supplementary form developed by the project team (see appendices) * current participation in any active psychotherapy (e.g., psychoanalysis, cbt) for mood, anxiety or substance use disorders (as determined via service member self report and/or check of medical record) * recurrent ptsd treatment failure in psychotherapy, as determined via consensus of study team members (dr. charles engel, dr. brett litz, and dr. kristie gore) * current alcohol dependence, as assessed by mini * acute psychosis, psychotic episode, or psychotic disorder diagnosis within the past year, as assessed by the mini * currently on an antipsychotic or mood-stabilizing agent for bipolar disorder or any disorder with psychotic features, as determined by medical record and/or self report * unstable administration schedule or dosing of any antidepressant, anxiolytic, or sedative-hypnotic (i.e., will exclude for any related medication changes in the month prior to randomization), as determined by medical record or service member self report * acute or unstable physical illness based on the judgment of the patient's primary care clinician and the study team.

Keywords: telemedicine, telephonic, ptsd
effects of hypopressive exercises in comparison with routine pelvic floor exercises in women with urinary incontinence

Conditions: Urinary Incontinence

Summary: the aim of our study is to compare the effects of hypopressive exercises with routine pelvic floor exercises in improving the frequency and severity of urinary incontinence in women and also to enhance their quality of life as it worsens after childbirth, pregnancy, and in older age.

a randomized control trial study will be conducted in which patients with urinary incontinence will be assigned to group 1 that will receive hypopressive exercises with electrical muscle stimulation (ems) and patients in group 2 will receive pelvic floor exercises with ems. the intervention will be applied (3 days/week) for 8 weeks. four sets of 10 repetitions with a 3-minute interval between each set will be performed for group 1 in an upright position while four sets of 10 repetitions with a 2-minute interval between each set will be performed for group 2 in the sitting position.

Eligibility criteria:
inclusion criteria: * women aged between 20 to 65 years * gynecologist and urologist diagnosed patients * participants not engaged systematically in sports or physical activities(≤ sessions per week, ≤ weeks per week) exclusion criteria: * if participants had hypertension or any serious mental disease * pregnancy or up to 2 months postpartum * urge fecal incontinence or vaginal pain * underwent any physiotherapy for urinary incontinence before * any kidney disease

Keywords: urinary incontinence pelvic floor exercises hypopressive exercises