Kornimate/medical-research-clean huggingface dataset:
effect of different strategies for titrating a high map on microcirculation

Conditions: Septic Shock; Hypertension

Summary: assess the effect of fluids and norepinephrine for mean arterial pressure titration to patients' usual level on the microcirculation of initial resuscitated hypertensive septic shock patients.

microcirculatory dysfunction plays an important role in the development of organ failure in patients with septic shock. numerous studies focus on the effect of mean arterial pressure (map) titration on microcirculation, however, by what strategy is better for microcirculation in septic shock patients with previous hypertension is still a matter of debate. the goal of this study was to assess the effect of different strategies for map titration to individualized level on microcirculation in hypertensive septic shock patients.

Eligibility criteria:
inclusion criteria: 1. hypertensive patients with septic shock for less than 24 hours. septic shock was defined by the 2001 sccm/esicm/accp/ats/sis international sepsis definitions conference. 2. initial fluid resuscitation was performed to maintain the central venous pressure (cvp) for more than 8 mm hg and central venous hemoglobin saturation for more than 70%. 3. patients were still requiring ne to maintain the map of 65 mm hg. exclusion criteria: 1. had severe untreated or uncontrolled hypertension (systolic blood pressure more than 180 mm hg or/and diastolic blood pressure more than 110 mm hg); 2. were younger than 18 years old or pregnant; 3. were unable to acquire the usual level or resting level of blood pressure; 4. refused to participate the trial.

Keywords: septic shock; microcirculation; norepinephrine
netosis in determination of respiratory infection severity

Conditions: Respiratory Infection

Summary: the study aims to evaluate the prognostic value of alveolar and blood netosis in patients under mechanical ventilation and treated for an acute low-respiratory tract infection. the main outcome is the occurrence of an acute respiratory distress syndrome (ards) according to the berlin definition.

neutrophils are the first line of defense against infectious injury. among the numerous mechanisms involving the immune system, neutrophil extracellular traps (nets) have been recently described as an additional way neutrophils are able to use to fight against bacteria. nets are made of dna and antimicrobial proteins. in the other hand, nets promote coagulation and may contribute to evolution of severe pneumonia into acute respiratory distress syndrome. the secondary objectives of the study include the research of the relation between blood netosis and alveolar netosis with: * the documentation of invasive pulmonary infection based on microbiological analysis criteria (which would be bacteria or viral) of lba at admission to icu; * the diagnosis value of usually used biomarkers: procalcitonin and c-reactive protein; * marbrure score at admission to icu; * arterial lactatemia; * scores of gravity at admission igsii and sofa; * all-cause mortality at day-28; * duration of mechanical ventilation at day-28; * duration of amines at day-28; * developement of hemodynamic failure; * developement of pulmonary circulatory failure. the study will include 1) 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure, 2) 10 control patients admitted to the icu after a planned vascular surgery and 3) 10 healthy subjects.

Eligibility criteria:
inclusion criteria: a/ for all subjets: * be \>/= 18 years of age on day of signing informed consent; * affiliated to the french social security - welfare system in france. b/ inclusion criteria for acute respiratory failure patients: admitted to the icu for acute respiratory failure requiring mechanical ventilation within the first 24 hours after admission and suspected to suffer from an infectious pneumonia, according to the following criteria: * recent fever; * acute respiratory failure signs (dyspnea, polypnea \> 30 cycles/min, hypoxemia pao2\<65 mmhg); * pulmonary focal signs of auscultation; * evocative signs in chest radiography or chest tdm. c/ inclusion criteria for control patients: - admitted to the icu for post-operative management of vascular surgery. exclusion criteria: a/ for all subjets: * pregnancy, * nosocomial pneumonia, * no social health insurance, * neutropenia of any cause; * patient refusal. b/ exclusion criteria for acute respiratory failure patients: - no mechanical ventilation within the first 24 hours after admission to the icu.

Keywords: acute respiratory distress syndrome adult icu neutrophil extracellular traps (nets) netosis neutrophils mechanical ventilation pneumonia
determining the barriers and motivations to clinical trial participation

Conditions: HIV

Summary: purpose: to comprehensively explore the barriers and motivators for participation in hiv clinical trials in a purposive sample of hiv positive patients receiving care at the unc id (infectious diseases) clinic participants: hiv positive patients seen at the unc id clinic. participants will be purposively sampled based on gender, race and previous participation in hiv clinical trials. blacks and patients who have never participated in clinical trials will be oversampled. procedures (methods): cross-sectional study using in-depth semi-structured qualitative interviews to determine the barriers and motivators for participation in hiv clinical trials. patient interviews will be audiotaped, transcribed verbatim and analyzed using atlas.ti software to understand the barriers and motivators for participation in hiv clinical trials.

study population: 48 hiv positive adult (at least 18 years of age) patients receiving care at the unc id clinic will be enrolled in the study. purposive sampling by race, gender and previous participation in hiv clinical trials will be used to ensure adequate representation in each category. participation in a clinical trial will be defined as having participated in a trial of highly active antiretroviral therapy (haart) for duration of \> 48 weeks. non-trial participation will be defined as having been offered the opportunity to participate in a clinical trial but have never participated in any clinical trial or participated in a trial that included a one-time sample collection with no follow up visits. study methods questionnaire: the questionnaire consists of open-ended questions to be administered to participants. the questionnaire items were composed by reviewing related studies. two versions of the questionnaire will be administered, one for participants with a history of participation in clinical trials and one for participants who were approached but have never been in a clinical trial (see appendix 1.) the questionnaire will be revised after pre-testing to incorporate changes before it will be administered to all 48 participants. interview: the interview will be conducted at the unc id clinic by one research assistant. the interview will take approximately 45 minutes and will be audiotaped.

Eligibility criteria:
inclusion criteria: * hiv-positive adults, * at least 18 years of age, * receiving care at the unc id clinic, * have previously been approached for (or offered) participation in a clinical trial. exclusion criteria: * non native english speaking patients * unable to provide informed consent * have never been offered participation in a clinical trial

Keywords: hiv clinical trials
safety of glaxosmithkline (gsk) biologicals hepatitis a vaccine in korean population

Conditions: Hepatitis A

Summary: glaxosmithkline korea has submitted a registration file for its hepatitis a vaccine. the present study will collect clinical data in the local target population as per the requirement of korean food and drugs administration (fda).

all subjects will be administered one dose of the hepatitis a vaccine.

Eligibility criteria:
inclusion criteria * subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g. be reachable over the phone) should be enrolled in the study. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent is obtained from the subject/ subjects' parents or guardians. exclusion criteria * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. (acute disease is defined as the presence of a moderate or severe illness with or without fever. all vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature \< 37.5°c (99.5°f) / axillary temperature \< 37.5°c (99.5°f) / rectal temperature \< 38°c (100.4°f) / tympanic temperature on oral setting \< 37.5°c (99.5°f) / tympanic temperature on rectal setting \< 38°c (100.4°f).
does limb pre-conditioning reduce pain after hip arthroscopy

Conditions: Hip Injuries; Hip Dislocation; Hip Fractures

Summary: the purpose of this study is to determine if the utilization of ischemic pre-conditioning 24-hours prior to hip arthroscopy decreases patient's post-operative pain and opioid consumption.

subjects will be asked to take part in one of two treatment procedures 24 hours prior to their scheduled hip arthroscopy date. subjects will be randomized into either the ipc or con group. these treatments consist of either 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion or 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion. the treatment will last 30 minutes. days 0-7 post-op will consist of self-reported pain scales and opioid consumption documentation in the morning and evening. this is a randomized single-blind research study. this study has two study groups: * the ipc group will get a standardized pre-conditioning treatment 24 hours prior to their hip arthroscopy. this consists of 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion while seated. * the con group will get a controlled treatment of 20% of limb occlusion pressure 24 hours prior to their hip arthroscopy. this consists of 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion while seated.

Eligibility criteria:
inclusion criteria: * patients undergoing a primary hip arthroscopy by the pi between the ages of 18 and 55. exclusion criteria: * patients younger than 18 or older than 55 who have had a previous hip arthroscopy, venous thromboembolism, and/or who take medications and/or supplements known to increase the risk of blood clots.
rivaroxaban in the treatment of venous thromboembolism (vte) in cancer patients

Conditions: Venous Thromboembolism; Cancer

Summary: the purpose of this study is to show feasibility (efficacy and safety) of rivaroxaban in the treatment of vte in cancer patients in comparison to the standard treatment with low molecular weight heparin (lmwh). tumor patients with active cancer and newly diagnosed thromboembolic events are randomised to receive either rivaroxaban or the standard treatment with low-molecular heparin.


Eligibility criteria:
inclusion criteria: * newly diagnosed and objectively confirmed acute venous thromboembolism * active malignancy * life expectancy of at least 6 months * performance-status according to karnofsky performance scale ≥ 70 % * patient's compliance and geographical situation allowing an adequate follow up * platelets ≥ 100.000 /μl, inr \< 1.5, ptt \< 40 sec. * written informed consent of the patient prior to any procedure in connection with the study * male and female patients with an age of at least 18 years exclusion criteria: * therapeutic anticoagulation \> 96 hours prior to study treatment * known allergic reactions against the study drugs or the substances included therein * known conditions associated with high risk of bleeding, known history of hemorrhagic diathesis * acute clinically relevant bleeding in the last 2 weeks * any history of spontaneous major/cerebral bleeding * history of heparin induced thrombocytopenia ii * pregnant or breast-feeding women. women of child-bearing potential must have a negative pregnancy test performed \< 7 days prior to start of the treatment * severe renal insufficiency (gfr \< 30 ml/min) * liver disease with coagulation impairment, including child b and c * cirrhosis * acute medical illness * treatment of the underlying cancer with experimental therapies
stress, sleep and cardiovascular risk

Conditions: Posttraumatic Stress Disorder; Insomnia

Summary: we are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease risk. we will examine the roles of pre-sleep cognition using a questionnaire and real time assessment, and modifiable strategies for coping with sleep disruptive cognitions. we will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.

the study has 3 specific aims. aim 1. to confirm the effects of neighborhood and posttraumatic stress, and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers. hypothesis 1a - neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence, and nocturnal/evening urinary noradrenergic excretion ratios. hypothesis 1b - these relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time, and strategies for coping with sleep disruptive thoughts. aim 2. to determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction. hypothesis 2 - indicators of nocturnal autonomic balance will correlate with morning levels of pro-inflammatory cytokines and adhesion molecules; and pulse wave velocity. aim 3. to determine if sleep is improved 6 months after receiving personalized recommendations for adaptively modifying sleep-related behaviors, and if improved sleep and reduced pre-sleep cognitive arousal are associated with more favorable nocturnal autonomic balance and endothelial function. hypothesis 3a - reduced frequency and intensity of sleep disruptive cognitions and improved sleep efficiency will be more likely in the group that received personalized feedback and recommendations for sleep. hypothesis 3b - reduction of disruptive pre-sleep cognitions, and increased sleep efficiency will be associated with improved autonomic status at night and a more favorable profile of cardiovascular risk biomarkers.

Eligibility criteria:
inclusion criteria:1. healthy adults age 18 - 35, self-identified as black or african american, born in the united states. exclusion criteria: * current medical or psychiatric condition that affects sleep or requires daily - use of medication other than ptsd, phobic disorders, or past history of major depression * severe alcohol or drug use disorders * overnight shift worker or an extreme chronotype * sleep disorder other than insomnia or nightmares * morbid obesity (body mass index \> 40)

Keywords: autonomic balance sleep endothelial function behavior stress
developing a pain identification and communication toolkit

Conditions: Dementia; Chronic Pain

Summary: the proposed research will develop, refine, and pilot test the pain identification and communication toolkit (pict), an intervention to help family caregivers of community-dwelling persons with dementia identify pain symptoms and communicate those symptoms to health care providers. informed by self-efficacy theory, pict will include: a) training in administering an observational assessment tool to identify pain in persons with dementia, b) coaching in effective communication about the person with dementia's pain symptoms, c) future planning for steps to take when pain is detected, and d) updating caregivers' skills through routine practice with the pain assessment tool. all components will be vetted and iteratively field-tested with a sample of racially and ethnically diverse caregivers of community-dwelling persons with dementia and health care providers. a two-group pilot randomized trial will examine the acceptability, feasibility, and preliminary impact of pict on caregivers' initiation of pain-related communication with health care providers.


Eligibility criteria:
for all phases: inclusion criteria: * family caregiver * age 21 or older * english speaking * cognitively intact * provides at least 8 hours of care per week to a person with dementia and pain * has provided care for at least 6 months exclusion criteria: * paid caregiver * age 20 or younger * non-english speaking * cognitively impaired * does not provide at least 8 hours of care per week to a person with dementia who also has a pain diagnosis * has not provided care for at least 6 months * currently enrolled in hospice * the patient to whom the caregiver provides assistance is in enrolled in hospice * care recipient does not have dementia diagnosis or pain diagnosis for field test and interview phases: healthcare professionals: * currently providing clinical services to persons with dementia and/or chronic pain * has provided these clinical services for at least 1 year
examining the effectiveness of multiwave locked system laser treatment in chronic low back pain

Conditions: Low Back Pain

Summary: patients who come to tavşanlı assoc. prof. dr. mustafa kalemli state hospital, physical therapy, and rehabilitation department who have been diagnosed with chronic low back pain by a physician will be included. patients will be divided into two groups by the physician: conservative treatment and patients whose treatment program is determined as multi-wave locked system laser treatment in addition to conservative treatment. pain intensity will be measured with a numerical pain rating scale. the roland-morris disability questionnaire will be used to evaluate the functionality of the participants, and the esthesiometer will be used to assess tactile acuity. pressure pain threshold will be evaluated with the microfet 2 device. the turkish form of the sf-12 quality of life scale will be used to assess the participants' quality of life. pittsburgh's sleep quality index will be used to evaluate sleep quality. patient satisfaction will be evaluated with a numerical rating scale.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * volunteering to participate in the study * having low back pain that has persisted for at least 3 months exclusion criteria: * history of surgery in the waist area * discopathy at a different level of the spine (modic type 3) * presence of tumor in the spine * infection in the discs * having an inflammatory disease * presence of neurological involvement * fracture * spondylosis * spinal stenosis * spondylolisthesis * radiculopathy * having received treatment for low back pain in the last 3 months
diagnostic performance of the vesical imaging-reporting and data system (vi-rads) in detecting muscle-invasive bladder tumour (mibc) in clinical practice: comparison with transurethral resection of bladder cancer (turb) and evaluation of diagnostic accuracy according to tumour location

Conditions: Bladder Cancer

Summary: vi-rads was an observational, prospective, multicenter, no profit study. the aim of the study was to clarify the clinical validity of the vesical imaging-reporting and data system (vi-rads) for the assessment of muscle invasion (mi) status in comparison with transurethral resection of bladder cancer (turb) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

the vi-rads (bladder imaging-reporting and data system) scoring system is an imaging tool that can help distinguish non-muscle-invasive from muscle-invasive disease prior to transurethral resection (turb). the vi-rads consists of a five-point scoring system based on the assessment of tumour size, morphology, growth, degree of restriction and contrast capture to assess the likelihood of bladder wall invasion. vi-rads was an observational, prospective, multicenter, no profit study. the aims of the study was to clarify the clinical validity of the vesical imaging-reporting and data system (vi-rads) for the assessment of muscle invasion (mi) status in comparison with transurethral resection of bladder cancer (turb) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

Eligibility criteria:
inclusion criteria: * patients with suspected primary bladder cancer at cystoscopy exclusion criteria: * impaired renal function * claustrophobia * allergy to paramagnetic contrast agent

Keywords: bladder cancer turb vi-rads
irinotecan and cisplatin in treating patients with locally advanced or metastatic penile cancer

Conditions: Penile Cancer

Summary: rationale: drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. combining irinotecan with cisplatin may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.

objectives: * determine the anticancer activity of irinotecan and cisplatin in patients with locally advanced or metastatic penile cancer. * determine the objective response rate and duration of response in patients treated with this regimen. * determine the acute side effects of this regimen in these patients. outline: this is an open-label, nonrandomized, multicenter study. patients receive irinotecan iv over 30 minutes on days 1, 8, and 15 and cisplatin iv over 1-3 hours on day 1. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients not undergoing local treatment receive up to 8 courses. patients planning to undergo surgery receive up to 4 courses. patients are followed every 8 weeks until disease progression and then every 3 months thereafter. projected accrual: a total of 13-28 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed penile squamous cell carcinoma * locally advanced or metastatic disease * t3, n1-2 or t4, n3, m1 * measurable disease outside of any previously irradiated field * no clinical signs of brain metastases patient characteristics: age * 75 and under performance status * who 0-2 life expectancy * not specified hematopoietic * absolute neutrophil count at least 2,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin no greater than 1.5 times upper limit of normal (uln) * alkaline phosphatase no greater than 2.5 times uln (5 times uln in the presence of liver metastases) * transaminases no greater than 2.5 times uln (5 times uln in the presence of liver metastases) renal * glomerular filtration rate at least 60 ml/min gastrointestinal * no chronic diarrhea * no unresolved bowel obstruction * no chronic inflammatory bowel disease (e.g., crohn's disease or ulcerative colitis) other * no other prior or concurrent malignancy except adequately treated skin cancer * no psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up prior concurrent therapy: biologic therapy * not specified chemotherapy * no prior chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * more than 4 weeks since prior radiotherapy * no concurrent radiotherapy for pain control surgery * not specified other * no other concurrent experimental or anticancer therapy

Keywords: penile squamous cell carcinoma stage iii penile cancer stage iv penile cancer