Kornimate/medical-research-clean huggingface dataset:
seattle-pap bubble nasal cpap and work of breathing

Conditions: Respiratory Distress Syndrome In Premature Infants; Bronchopulmonary Dysplasia; Newborn Primary Sleep Apnea

Summary: the investigators propose to test the hypothesis that seattle bubble nasal continuous positive airway pressure (seattle-pap) supports respiratory physiology in very low birth weight (vlbw) infants more effectively than standard bubble nasal continuous positive airway pressure.

the primary outcome variable is work of breathing (wob) over a two hour period, estimated from pressure-rate products, which are assessed with 6 fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (pes), thereby estimating changes in pleural pressures during breath cycles. the following endpoints would also be assessed: oxygen saturations and fraction of inspired oxygen (fio2) needed to keep saturations in acceptable ranges, heart rates (hr), transcutaneous carbon dioxide (tcpco2), and respiratory rates throughout the 6 hour study period. objective determination of when an infant requires more or less respiratory support is difficult, but measurements of pressure-rate products as estimates of work of breathing, using esophageal catheters, can estimate an infant's respiratory effort. however, objective, simple-to-use, low cost, and non-invasive methods and tools to determine an infant's respiratory effort do not exist currently. this study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.

Eligibility criteria:
inclusion criteria: * infant born less than 32 weeks gestation * admitted to texas pavilion for women * between 6 and 72 hours post delivery * stable on standard bubble nasal cpap * informed consent exclusion criteria: * major congenital anomalies or suspected chromosomal anomalies

Keywords: bubble nasal continuous positive airway pressure (bn-cpap) work of breathing pressure-rate products
mediclas study (metabolic effects of different classes of antiretrovirals)

Conditions: HIV Infections; HIV-Associated Lipodystrophy Syndrome

Summary: this is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in hiv-1-infected men.

this is a randomized prospective study into metabolic adverse events during initial antiretroviral therapy in hiv-1-infected men. the following regimens are compared: lopinavir-ritonavir + combivir and lopinavir-ritonavir + nevirapine (nucleoside reverse transcriptase inhibitor \[nrti\]-sparing). prior to the start of therapy and 3, 12, 24, and 36 months thereafter the distribution of body fat and bone density (bioelectrical impedance analysis \[bia\], computed tomography \[ct\] and dual energy x-ray absorptiometry \[dexa\]), lipid spectrum, mitochondrial dna (peripheral blood mononuclear cells \[pbmcs\] and adipose tissue biopsies) and vascular measurements are performed. in addition, insulin sensitivity is measured in a subgroup of sixteen individuals by using a hyperinsulinemic euglycemic clamp and performing microvascular measurements. the aim of the study is to obtain prospective insight into the occurrence of various aspects of metabolic adverse events on the one hand and to compare an nrti-containing therapy with an nrti-sparing therapy on the other hand. the hypothesis is that in the nrti-sparing arm, less metabolic and vascular changes are observed than in the nrti containing regimen.

Eligibility criteria:
inclusion criteria: * male * age between 18 and 70 years. * no prior use of antiretroviral therapy * indication for antiretroviral treatment according to common standards exclusion criteria: * female sex * body mass index (kg/m2) \> 35. * known history of diabetes mellitus or hyperlipidemia * use of coenzyme a reductase inhibitor or fibric acid derivative in the last 6 weeks before inclusion * use of the following medication: systemic corticosteroids, thiazide diuretics, calcium-entry blockers, angiotensin-converting inhibitors, nitrates * use of nandrolone or testosterone * any disorder or condition which can be expected to lead to lessened compliance with the study protocol.

Keywords: hiv hiv-associated lipodystrophy syndrome
ct-2584 in treating patients with metastatic prostate cancer that has not responded to previous therapy

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. ct-2584 may stop the growth of prostate cancer by stopping blood flow to the tumor. purpose: randomized phase ii trial to study the effectiveness of ct-2584 in treating patients who have metastatic prostate cancer that has not responded to previous therapy.

objectives: i. compare the efficacy, safety, and pharmacokinetics of 2 different treatment schedules of ct-2584 in patients with hormone refractory, metastatic adenocarcinoma of the prostate. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms: arm i: patients receive ct-2584 iv over 6 hours daily for 3 days every 3 weeks. arm ii: patients receive ct-2584 iv over 6 hours once every 7 days for 3 weeks. courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: approximately 80 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven metastatic adenocarcinoma of the prostate refractory to hormonal therapy failed at least 1 nonhormonal therapy (prior radiotherapy allowed, but does not constitute nonhormonal therapy) no cns metastases patient characteristics: age: 18 and over performance status: 60-100% life expectancy: not specified hematopoietic: no known or suspected red blood cell disorder (e.g., hereditary spherocytosis, paroxysmal nocturnal hematuria, sickle cell trait, autoimmune hemolytic disorder) hepatic: bilirubin no greater than 1.5 mg/dl no severe liver dysfunction, particularly, no impaired hepatic synthetic functions as evidenced by prolonged prothrombin time or otherwise unexplained serum albumin less than 3 g/dl renal: creatinine no greater than 1.5 mg/dl cardiovascular: no evidence of congestive heart failure no clinically significant cardiac arrhythmia no prior or concurrent symptoms of acute coronary artery disease no significant cardiac valve disease (e.g., aortic stenosis, valve prosthesis) pulmonary: no prior asthma during adulthood that required therapy other: no prior seizures or drug related anaphylactic reactions no history of microangiopathy (e.g., cavenous hemangioma, prior thrombotic thrombocytopenic purpura) prior concurrent therapy: biologic therapy: at least 4 weeks since prior systemic biologic therapy for prostate cancer and recovered chemotherapy: at least 4 weeks since prior chemotherapy (12 weeks for strontium-89 and 6 weeks for bicalutamide) and recovered endocrine therapy: see disease characteristics radiotherapy: see disease characteristics no concurrent radiotherapy surgery: at least 3 weeks since prior major thoracic or abdominal surgery other: at least 4 weeks since other prior investigational drugs (except bisphosphonates) and recovered

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer
impact on pain sensitivity of clinical interaction

Conditions: Pain Measurement

Summary: pain can currently be quantified using quantitative sensory tests (qsts). however, we lack knowledge concerning how relational and contextual factors impact these quantitative tests. we will examine how a standard qst battery is affected by "removing" the social and human interaction from the test session compared to usual qst testing where the participant is guided through the assessment by a research assistant. our objectives are: 1. how is the qst affected when guided by a research assistant compared to guided by a computer 2. does the level of the assessor's empathy affect the qst outcome 3. how do psychological factors affect the qst testing 4. are these outcomes affected by the patient profile (low back pain patients vs healthy controls)


Eligibility criteria:
inclusion criteria: * primary complaint of low back pain * no pain for healthy controls * no serious psychological or somatic disorders potentially interfering with the qst exclusion criteria: * incomplete qst data

Keywords: low back pain
pediatric pectointercostal and esp block

Conditions: Postoperative Pain

Summary: american society of anaesthesiologist physical status ii-iii, aged between 2, 12 patients which underwent open cardiac surgery will recruited to this study. these subjects will ultrasound (usg) guided erector spinae block will perform at t6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. totally bupivacaine %0.25 2.5 mg/kg will use blocks. 2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. postoperative pain and agitation assessment will perform with flacc and watcha scores

american society of anaesthesiologist physical status ii-iii, aged between 2-12, 60 patients which underwent open cardiac surgery will recruited to this study. the patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. ultrasound (usg) guided erector spinae block will perform at t6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in group block and block will not perform to the control group. sevoflurane+remifentanil and o2/air combination will perform to the all patients during the surgery. totally bupivacaine %0.25 2.5 mg/kg will use for blocks.2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. postoperative pain and agitation assessment will perform with flacc and watcha scores. flacc, watcha scores, morphine consumption and complications will record.paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. the patient controlled anesthesia with morphin will apply to the all patients. if the flacc score is higher than 4, morphine 0.015 mg/kg will administer intravenously.

Eligibility criteria:
inclusion criteria: * ages between 2-12 years * asa ii-iii children * the children who undergoing open heart surgery exclusion criteria: * coagulopaty * allergy of local anesthetic * liver and renal failure * obesity (bmi \>35kg/m2) * infection at the block area
association between depression and iron metabolism in hemodialysis patients

Conditions: Hemodialysis

Summary: this study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis.

the beck depression inventory (bdi), second version, was used to quantify the levels of depression. mean age, duration of hd, hemoglobin levels, serum ferritin levels, serum iron levels, tsat, tibc, serum albumin levels, crp and energy consumption (kcal/week) were included in the model as multivariate variables. backward stepwise logistic regression (roc) analysis was performed.

Eligibility criteria:
inclusion criteria: * patients with stable undergoing hemodialysis exclusion criteria: * patients those who refused to join present study, and those who could not complete the questionnaires by themselves, and the patients with chronic hepatitis b or c were excluded.

Keywords: depression
effects of glutamine in ischemic heart disease patients following cardiopulmonary bypass

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether perioperative glutamine administration possess protective properties on internal organs (heart and gut) in patients with coronary atherosclerosis, operated under cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * adult patients with coronary artery disease operated on under cardiopulmonary bypass exclusion criteria: * ejection fraction\<40% * viral hepatitis * liver cirrhosis * cholecystitis * pancreatitis * chronic severe gastrointestinal disease * surgery on gastrointestinal tract in patient's medical history
early detection of cteph in patients after ape

Conditions: Chronic Pulmonary Thromboembolism

Summary: the project is a national, prospective, multicenter, interventional pilot project of screening cteph in pacients after ape in the czech republic. the main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of chronic tromboembolic pulmonary hypertesion in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.

the project is a national, prospective, multicenter, interventional pilot project of screening cteph in pacients after ape in the czech republic. the global goal of the project is to develop, test and implement a uniform procedure for early detection of patients with cteph and to set up a process for their rapid referral to a specialized center that treats chronic thromboembolic pulmonary hypertension. the timeliness of the treatment set up has a significant impact on patient's future quality of life and eliminates the risk of subsequent complications or death. the main objective of this activity is to validate the cteph screening process, which will benefit 500 patients in approximately 10 selected centres. subsequently, patient flow from the cardiologist to a specialised pulmonary hypertension treatment centre will be ensured. the process will include a review and evaluation of the screening algorithm in patients in the pilot. the project is supported by the european social fund (operational program employment plus) and the state budget of the czech republic and is registered by the ministry of labour and social affairs of the czech republic under id: cz.03.02.02/00/22_005/0002007

Eligibility criteria:
inclusion criteria: * age over 18 years * signed consent to participate in the project and gdpr * patients with an episode of acute pulmonary embolism in the last 3-12 months, with ongoing anticoagulation therapy: 1. patients with new-onset and ongoing or progressive dyspnea (min. nyha ii) after a pulmonary embolism episode or worsening of dyspnea after a pulmonary embolism episode compared to the status before the episode (at least 1 hyha grade) or 2. asymptomatic patients after a pulmonary embolism episode and at least one of the following risk factors: * echo evidence of severe ph at diagnosis of pe (pasp \>60 mmhg) * antiphospholipid syndrome with triple positivity (presence of lupus anticoagulans + anti-beta-2-glycoprotein i (b2gpi) antibodies + anticardiolipin) * infected permanent venous inlets and cardiac pacing/defibrillation intravascular systems * presence of ventriculoatrial shunt for treatment of hydrocephalus * nonspecific intestinal inflammation (ulcerative colitis, crohn's disease) * history of splenectomy * myeloproliferative disorders * chronic osteomyelitis exclusion criteria: * not agreeing to participate in the project * contraindications to treatment

Keywords: cteph ape early detection czech republic
pre-hospital wireless transmission of electrocardiograms to a cardiologist via a hand-held device

Conditions: Myocardial Infarction

Summary: aim: to determine the impact of wireless transmission of prehospital ecgs to a hand-held computer on time to treatment and myocardial salvage in acute mi patients. background: the time-1 investigators documented a 27% (109 to 80 minutes) reduction of time from emt arrival at the scene to successful primary pci implementing pre-hospital ecg transmission to the ed. ecg transmission directly to a physician's cellular phone/pda through a wireless modem has only recently become an option. the recently completed time-northeast (ne) study tested the welch allyn version of this system and the results show a reduction in time to reperfusion for acute mi patients by 66 minutes (116 to 50). methods: this study will involve approximately 20 sites around the country. the study will be divided into two phases: a consecutive control data collection phase (phase i) and an intervention with concurrent control phase (phase ii). phase ii will begin after installation of welch allyn ecg transmission equipment. the primary end-point will be time to reperfusion and secondary end-points will include myocardial salvage, aborted infarction and hospital mortality. ecg measurements will be made at a central ecg core lab by a blinded investigator. data analysis: patient characteristics for the three periods were compared with the chi-square statistic for categorical variables and one-way analysis of variance for age. the wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and study periods as well as in the group 1 post-study period. comparisons were performed separately for ems and self-transport groups.


Eligibility criteria:
inclusion criteria: all patients with a diagnosis of acute stemi defined as 1 mm st segment elevation in two spatially contiguous leads were included. there were two major subgroups: emergency medical services (ems) and self-transport patients. self-transport patients, who did not have ph-ecg transmission, served as a comparison group. exclusion criteria: * less than age 18 * no intent to undergo reperfusion therapy (pci or thrombolytics)

Keywords: ems patients with intention to treat with coronary reperfusion therapy (pci or thrombolytics) based on their initial presentation
the effects of leucine on body weight

Conditions: Overweight; Obesity

Summary: protein-rich diets appear to show some benefits in promoting weight loss. it is thought that increased intake of leucine may account for some of this effect. this study is designed to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply to humans. specifically, our team would like to determine whether oral leucine supplementation in overweight/obese humans increases metabolic rate, reduces body weight, improves glucose utilization and/or, reduces circulating fat levels in the blood. we hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. this study will should provide data that can be used to design more definitive trials with regard to dietary leucine supplementation. hypothesis this pilot study is designed to accomplish the following two goals: 1. to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply in humans. specifically, we want to determine whether oral leucine supplementation in overweight/obese individuals' increases basal metabolic rate, reduces body weight, improves glucose tolerance and/or insulin sensitivity, and/or reduces circulating low-density lipoprotein (ldl)-cholesterol levels. 2. to provide data that can be used to design more definitive trials with regard to dietary leucine supplementation. we hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. this would in turn lead to more rigorous clinical trials involving larger sample sizes, and with diverse populations of different gender, age, and ethnic groups. future trials may also be directed to determine minimal doses and durations of leucine supplementation that are capable of achieving clinically significant improvement in the cardio-metabolic risk profile in people.


Eligibility criteria:
inclusion criteria: * 18-65 year old overweight/obese * healthy men and women * body mass index (bmi) of 28-35 exclusion criteria: * unusual or extreme dietary or exercise habits * daily leucine supplement use * inability to follow instructions to drink liquid meals * type 1 diabetes or type 2 diabetes on drug treatment(diet controlled diabetics will be enrolled after consulting with their treating physicians) * hypothyroidism or hyperthyroidism * chronic wasting diseases (acquired immune deficiency syndrome (aids), cancers, cirrhosis, renal failure, chronic obstructive pulmonary disease (copd), heart failure) * drug or alcohol abuse * tobacco smoker within the past 6 months * pregnancy or lactating * use of medications known to affect carbohydrate or lipid metabolism, satiety, or hunger * anemia * abnormal liver function tests (lfts) * women who are of child bearing age without adequate birth control modality

Keywords: leucine weight loss
efficacy of autologous conditioned serum in temporomandibular joint disorder

Conditions: Temporomandibular Joint Osteoarthritis

Summary: temporomandibular joint (tmj) disorders are health conditions that can occur at any age and are recognized as the most common cause of chronic pain, affecting 5-12% of the population. pain in the tmj region can lead to limitations in mouth opening and lateral movements of the mandible. in cases where conservative treatments are insufficient for tmj disorders and osteoarthritis, symptoms can be alleviated through arthrocentesis, a minimally invasive procedure with a low risk of complications, or through various intra-articular injection applications following arthrocentesis. this study aims to compare the clinical efficacy of intra-articular applications of platelet-rich plasma (prp) and autologous conditioned serum (acs), both derived from the patient's own blood, in order to evaluate their impact on treatment outcomes and their potential role in enhancing patient care in routine clinical practice."

temporomandibular joint (tmj) disorders are health conditions that can occur at any age and negatively impact quality of life. one of the treatment methods for this condition includes arthrocentesis and intra-articular injections. among the cytokines identified in orthopedic and trauma-related diseases, interleukin-1 (il-1) has been shown to have particular significance. increased local cytokine release triggers the destruction of hyaline cartilage and matrix, leading to osteoarthritis and worsening symptoms. although the details vary, published studies suggest that when il-1ra is present at concentrations 10 to 10,000 times higher than il-1, all il-1 receptors and il-1-triggered reactions can be effectively blocked. with the sanakin®-acrs kit developed by genesis biomedical, a patient's blood is drawn, incubated, and then centrifuged, resulting in a serum rich in il-1ra and growth factors-known as autologous conditioned serum (acs). studies have demonstrated that acs injections yield highly successful results in treating knee and tmj osteoarthritis. additionally, numerous studies have shown that platelet-rich plasma (prp), which contains a high concentration of growth factors, is also highly effective in wound healing. this study is designed to compare the effectiveness of prp and acs injections-both derived from the patient's own blood but prepared using different methods-in alleviating symptoms associated with temporomandibular joint (tmj) disorders. the investigation aims to assess their efficacy as accessible, cost-effective, and low-risk treatment alternatives."

Eligibility criteria:
inclusion criteria: * over 18 years old * previously received conservative treatment but no improvement in symptoms * patients with tmj osteoarthritis exclusion criteria: * patients who have experienced tmj trauma or have undergone surgical procedures in this region will be excluded from the study. * patients with facial growth disorders, systemic inflammatory joint diseases, condylar pathologies, or signs of myalgia * patients who are pregnant or in the lactation period

Keywords: arthrocentesis, tmj platelet-rich plasma