Kornimate/medical-research-clean huggingface dataset:
alterations in the plasma proteome of early-onset severe preeclampsia

Conditions: Preeclampsia

Summary: the hypothesis of this study is that many plasma proteins are altered in concentration and structure in preeclampsia and the elucidation of these alterations will add to the poorly understood pathophysiology of preeclampsia. in this study we will compare the maternal plasma proteomes of early-onset severe preeclampsia versus healthy controls, compare protein expression and quantification of the maternal plasma proteome at the time of diagnosis of eos-preeclampsia to the plasma proteome of the same affected subject at 48 hours post delivery and we will verify the placental expression of differentially expressed or post-translationally modified proteins found in the plasma of women with eos-preeclampsia.

preeclampsia affects 7-10% of all pregnancies and is directly responsible for 50,000 maternal deaths and 900,000 perinatal deaths each year. preeclampsia remains unpredictable and incurable except through premature delivery of the fetus. it is essential that a better understanding of preeclampsia is obtained. proteomics offers a methodology for identification and quantification of each protein fraction found in human plasma in both disease and health. since proteins are the basic elements of human biology, it is anticipated that alterations in protein posttranslational modification or total protein expression would be indicative and diagnostic of a disease state. because proteins are recognized to act as messengers through hormone action, act as enzymes to catalyze important organic reactions and serve as structural components of the human body, they are the most representative of the current state of metabolic and structural activity in both the naive and disease state. two groups of patients will be enrolled: (1) patients with eos-preeclampsia (n=60) and (2) healthy patients with normal pregnancies (n=240). the patients with eos-preeclampsia will be matched (1:4) with contemporaneous control patients who are carrying a singleton gestation at a similar gestational age. to measure changes in proteins, we will compare proteins in the blood plasma of women with eos-preeclampsia before and after pregnancy. we will also compare the blood plasmas of healthy versus eos-preeclamptic women for differences in plasma proteins. finally, we will examine the placental rna of patients with eos-preeclampsia and healthy patients delivered at 35-37 weeks gestation.

Eligibility criteria:
inclusion criteria: * 20-34 weeks completed gestational age exclusion criteria: * multiple gestation * chronic hypertension * diabetes * lupus * tobacco use

Keywords: preeclampsia proteome pregnancy
hpv and male homosexuality in general practice?

Conditions: Papilloma Viral Infection

Summary: the main objective of this study is to find out whether young msm (men who have sex with men) believe it is important for their gp to be informed of their sexual orientation, in order to improve their clinical, especially with hpv vaccination. the secondary objective is to analyze the state of knowledge about the hpv vaccine and the value of hpv vaccine in this target population.


Eligibility criteria:
inclusion criteria: * age: 18-26 years * consultation at the hus cegidd as part of an sti screening * subject who expressed no opposition to participating in the study exclusion criteria: * refusal of the patient to participate in the study * subject who had already benefited from hpv vaccination (at least one dose) * inability to give informed consent * subject under safeguarde of justice * subject under guardianship or under curatorship

Keywords: papilloma viral infection hpv hpv vaccine
nutritional status and its modifications after hip replacement

Conditions: Hip Arthropathy; Malnutrition; Anemia; Frail Elderly Syndrome

Summary: data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. it is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. the observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. this study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.

data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. it is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. patients undergoing hip surgery would be enrolled before the surgical operation and would be evaluated three times: preoperative, postoperative, and after discharge. the observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. this study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.

Eligibility criteria:
inclusion criteria: * caucasian * arthroplasty intervention program with hip prosthesis placement * signature and acceptance of informed consent to collaborate in all the procedures necessary for the study exclusion criteria: * heart failure stage iii-iv * renal failure stage iii-iv * actual cancer * past neurological disorders (including, but not limited to cerebral ischemia, cerebral haemorrhages, brain tumors, endocranial aneurysms) * neurodegenerative disorders (including, but not limited to alzheimer's dementia, fronto-temporal dementia) * actual major psychopharmacological therapies * pregnancy certified by self-declaration * inability to adhere to the rehabilitation protocol or to carry out the controls * non-acceptance of informed consent * revision interventions * previously established and documented sleep disorders * shift or part-time worker
a two-part single- and repeat-dose study of csj137 in anemic chronic hemodialysis patients

Conditions: Anemia, Iron-Deficiency

Summary: the study will assess the safety, tolerability and efficacy of csj137 in chronic hemodialysis patients. it is hypothesized that treatment with csj137 may improve the level of hemoglobin in patients on chronic hemodialysis with iron-restricted anemia while reducing the need for dosing with erythropoietin and intravenous iron in these patients.

this posting discloses information about part 1 of ccsj137x2201. another part, part 2, of this trial was planned for conduct subsequent to the initiation of part 1 and would have a different design than part 1. however, due to internal strategic non-safety related decision, part 2 is not going to be conducted and the trial will be terminated after part 1.

Eligibility criteria:
inclusion criteria: 1. hemodialysis-dependent for at least 2 months prior to screening. 2. receiving hemodialysis at least 2 times per week 3. receiving erythropoietin (epo) therapy. 4. hemoglobin (hgb) ≥ 8.5 and \< 11.5 g/dl at screening. 5. ferritin \>500 ng/ml and ≤ 2000 ng/ml at screening. 6. tsat ≤ 50% at a minimum of one time point during the 90 days prior to baseline. exclusion criteria: 1. known diagnosis of hemochromatosis, bone marrow malignancy, lymphatic malignancy or myelodysplastic syndrome. 2. history of dialysis av fistula thrombosis within 2 months prior to screening, or 2 or more episodes of av fistula thrombosis within 6 months prior to screening. 3. liver disease/dysfunction (child-pugh score ≥ 6), prior liver transplant, heart failure (nyha class iii or iv); gastrointestinal bleeding. 4. a positive hepatitis b surface antigen test result. patients with hepatitis c virus (hcv) infection may be included if all other liver function eligibility criteria are met. 5. alt, ast or bilirubin ≥ 1.5x uln within 4 weeks prior to baseline. 6. uncontrolled renal osteodystrophy 7. conditions predisposing to an increased risk of serious infection, such as an indwelling vascular catheter (central venous line or non-tunneled/acute hemodialysis catheter) or active infection requiring antibiotic therapy at any time during the 2 weeks prior to screening. tunneled hemodialysis catheters, and other "permanent" catheters are permitted. 8. blood transfusion administered within 4 weeks prior to baseline. 9. patients who received csj137 dose in the past. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: anemia
thoracoabdominal asynchrony and respiratory distress

Conditions: Respiratory Insufficiency

Summary: the investigators hypothesize that a simple 3-point tracking device that uses motion sensors attached to the abdomen and chest of a child will provide information regarding thoracoabdominal asynchrony (taa), a major component of respiratory distress, and ultimately help guide a clinician to initiate, escalate, de-escalate, or stop respiratory support interventions. aims to determine if the taa-monitoring device can be used to detect differences in respiratory synchrony in a manner that is clinically applicable. the investigators hope that the device will detect 1) major asynchrony events in a timely manner so as to prompt clinician intervention during future use; and 2) asynchrony events that may be less visible to the naked eye that may be precursors to more severe events.

respiratory diseases are a major global cause of morbidity and mortality in children. of patients admitted into a pediatric intensive care unit (picu), respiratory illnesses have been identified as the leading principal admission diagnosis in every age group, accounting for 37.9% of patients under 12 months of age and 28.5% of picu patients across all age groups. continuous monitoring of respiratory status is important for the guidance of respiratory support escalation and de-escalation decisions in the picu. a clinical metric that has been suggested as a signature of breathing effort is thoracoabdominal asynchrony (taa), the non-coincident motion of the rib cage and abdomen during breathing. a reliable, objective assessment tool for continuous monitoring of respiratory effort could allow for a more complete understanding of patients' real-time respiratory status and provide an additional indication or contraindication for the utilization of various levels of respiratory support. limiting the use of invasive ventilatory support by early detection of respiratory distress would decrease clinical risk to patients and has the potential to decrease the cost of patient stays in the picu. the investigators have developed a non-invasive taa-sensing device designed for use by clinicians to indirectly quantify respiratory effort among pediatric patients (henceforth referred to as the "taa-monitoring device"). the device utilizes motion-tracking sensors that capture data that is then processed to provide a quantitative indication of a patient's respiratory status. given the promising yet inconclusive nature of the evidence supporting the use of taa as an indicator of respiratory effort, clinical validation of this device is a necessary step to take to support its continued development.

Eligibility criteria:
inclusion criteria: 1. patients 28-days to 17-years of age 2. who have respiratory distress and those who do not have respiratory distress exclusion criteria: hardware, clinical care, or dermal injury that would preclude the application of taa device
comparison of pvi plus catheter ablation or pvi alone for the treatment of afib for patients with paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: there is a need to compare the efficacy of pvi versus pvi plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (cfae) and linear lesions in the same procedure. if it is found that the pvi alone is as effective as pvi plus catheter ablation of cfae and linear lesions, it may reduce the need for catheter ablation.


Eligibility criteria:
inclusion criteria: (step 1 - registration) * the subject is 18 years of age or older * left atrium \< 6.0 cm (trans thoracic echo - tte - parasternal 4 chamber view * performed within 6 months) * documentation of af that terminates spontaneously or with intervention within 7 days of onset (paf) failed or refractory to one aad (class i and/or iii) * provided written informed consent * be eligible for an af ablation procedure for paroxysmal af (step 2 - randomization) * sustained af following pvi with ability to receive additional linear or focal intracardiac catheter ablation exclusion criteria: (step 1 - registration) * pregnant or planning to become pregnant during study * co-morbid medical conditions that limit one-year life expectancy * previous cardiac surgery * patients who have active infection or sepsis * patients with esophageal ulcers strictures and varices * patients who are contraindicated for anticoagulants such as heparin and warfarin * patients who are being treated for ventricular arrhythmias * patients who have had a previous left atrial catheter ablation for af (does not * include ablation for afl or other supraventricular arrhythmias) * current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment * not competent to legally represent him or herself (e.g., requires a guardian or * caretaker as a legal representative) (step 2 randomization) * not able to receive additional linear or focal intracardiac catheter ablation
comparison of the effects of robotic rehabilitation versus traditional balance training on balance and fear of falling in stroke patients

Conditions: Stroke; Stroke Rehabilitation; Robotic Exoskeleton

Summary: in the literature, it has been observed that traditional balance training (tbt) and robot-assisted walking training (ragt) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. however, it is seen that there is no clear protocol for ragt in the chronic period. combined ragt and tbt approaches over ten weeks have been shown to be more effective than tbt alone for the acute and subacute period. however, there is no definite expression for chronic period effects. no study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving tbt and ragt. if changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after tbt and ragt in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.


Eligibility criteria:
inclusion criteria: * being 18 years or older * volunteering to participate in the study * having been diagnosed with stroke (at least 3 months) * age range 18 ≥ or 75 \< * being able to walk independently (functional ambulation scale\> 3) * modified ashworth scale ≤ 2 spasticity value exclusion criteria: * being under the age of 18 * having severe visual and cognitive impairment * having severe cardiovascular disease * having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores) * being involved in a robotic rehabilitation program before

Keywords: stroke stroke rehabilitation robot assisted gait training balance training fear of falling
the impact of early norepinephrine administration on outcomes of patients with sepsis-induced hypotension

Conditions: Norepinephrine; Sepsis; Hypotension

Summary: septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (map)≥ 65 mmhg and a serum lactate level of \> 2 mmol/l (18 mg/dl) despite sufficient volume resuscitation . hypovolemia (both relative and absolute) and reduced vascular tone have a role in determining the severity of hypotension in septic shock

septic shock is defined as sepsis with persistent hypotension requiring vasopressors to maintain mean arterial pressure (map)≥ 65 mmhg and a serum lactate level of \> 2 mmol/l (18 mg/dl) despite sufficient volume resuscitation . hypovolemia (both relative and absolute) and reduced vascular tone have a role in determining the severity of hypotension in septic shock . when mean arterial pressure (map) falls below a specific critical level organ blood flow is physiologically dependent on perfusion pressure. fluid resuscitation and vasopressors have an influence on hypovolemia and the vascular tone in the early phase, as fluid resuscitation aims to correct hypovolemia and vasopressors-norepinephrine (ne)- as a first-line drug aiming to restore vascular tone to assure organ perfusion . norepinephrine is both an alpha1- and beta1-agonist so it is able to increase vascular tone and contractility . nevertheless, a large amount of fluids will increase the risk of fluid overload, which is a common complication during septic shock resuscitation * after the early phase, only fifty percent of patients respond to fluid administration, meaning that fluid treatment cannot boost cardiac output (co) the current data indicate that the time from the onset of septic shock to the initiation of norepinephrine administration is a significant survival predictor; however, a suggestion for the optimal time to provide norepinephrine support was not explicitly expressed

Eligibility criteria:
inclusion criteria: * adult patients aged from18 to 65 years old * had the diagnostic criteria for sepsis as the presence of infection * systemic manifestations of infection and signs of hypoperfusion exclusion criteria: * acute cerebral vascular event * active cardiac conditions * valvular heart diseases * hypotension suspected to be due to another cause and comorbidities * status asthmatics * active hemorrhage * pregnancy * burn injury * requirement for immediate surgery * advanced-stage cancer * refusal to participate in the study
3d joint space evaluation in knee osteoarthritis: the importance of weight-bearing and flexion

Conditions: Osteoarthritis, Knee

Summary: rationale: osteoarthritis (oa) is mainly characterized by cartilage degeneration. in knee oa, measuring the distance between the tibia and femur, known as the joint space width (jsw), is an often-used method to quantify the progression of the disease or the effectiveness of treatments, because it is an indirect measure of cartilage degeneration. however, jsw is often measured while the patient is standing (weight-bearing) with slightly flexed knees, with a flexion angle of around 7-10 degrees, while direct cartilage thickness measurements are usually performed while the patient is lying down (non-weight-bearing) with an extended leg \[1\]. because of this difference in positioning, it is difficult to compare different jsw and cartilage thickness measures, as it is not clear what happens with the jsw distribution in the joint when a patient changes position between weight-bearing/non-weight-bearing and flexion/extension. in this study, we aim to identify the changes that occur in the knee of oa patients under the influence of weight-bearing and/or flexion, to enable comparing joint space measures from different positions. in this research we want to use mri as a three-dimensional imaging technique because there is no radiation involved.. objective: to evaluate how the 3d knee joint space distribution in knee oa patients changes under the influence of weight-bearing (upright) and flexion mri scanning. study design: explorative cross-sectional study. study population: 21 patients with symptomatic knee osteoarthritis (kellgren-lawrence grade 2 or 3) are included from the orthopaedics department of medisch spectrum twente in enschede. main study parameters/endpoints: the primary study parameter is the change in medial joint space width between the different positions (weight-bearing/non-weight-bearing and flexion/extension).


Eligibility criteria:
inclusion criteria: * patients with symptomatic knee osteoarthritis in at least one knee * \> 18 years old * kellgren-lawrence grade (severity) 2 or 3 * good knowledge of the dutch language * signed informed consent exclusion criteria: * previous surgery in (both) symptomatic knee(s) * inability to stand for 15 minutes, without assistance * unable to fit knee in the mri coil (knee width \> \~15 cm) * not eligible for mri, in response to the mri safety checklist
risperidone and suicidality in major depressive disorder

Conditions: Depression

Summary: the purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder.

using a double blind, placebo-controlled design, subjects diagnosed with a current episode of major depressive disorder (defined by dsm-iv criteria and supported by the mini international neuropsychiatric interview), severe with suicidality despite currently taking an antidepressant, will be enrolled in the eight-week study. the treatment will be initiated by randomizing patients to receive risperidone or placebo in addition to the antidepressant that the patient is already taking. the clinical efficacy will be evaluated after 4 days, weekly for 4 weeks, then every other week for 4 weeks with the efficacy measures. during the eight-week study, treatment with risperidone or placebo will continue at the highest effective dosage (up to 2 mg per day). the dose of the antidepressant will not be changed during the study.

Eligibility criteria:
inclusion criteria: 1. 19-60 years of age 2. diagnosis of major depressive disorder, currently severe with suicidality 3. a total score of montgomery-asberg depression rating scale (madrs) =/\> 25 with the suicide sub-score =/\> 4 4. currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks 5. in good physical health exclusion criteria: 1. depression without suicidality 2. presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder) 3. depressive symptoms induced by alcohol or substance abuse 4. psychotic features which are predominant at the initial evaluation 5. unstable major medical illness, such as cardiac disease or diabetes 6. female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures

Keywords: suicidality antipsychotic antidepressant treatment