Kornimate/medical-research-clean huggingface dataset:
the strategy of "pulmonary opening by titration of positive end-expiratory pressure" means of a pulmonary recruitment maneuver in patients with acute respiratory distress syndrome: for which patients?

Conditions: Respiratory Distress Syndrome, Adult

Summary: pulmonary recruitment maneuvers open these lung areas and appropriate adjustment of positive expiratory pressure (pep) helps to stabilize recruitment and reduce the stress associated with alveolar opening and closing. its beneficial effects in the lung affected by acute respiratory distress syndrome (ards) remain unclear. the hypothesis is that there is a heterogeneous effect of the recruitment maneuver according to the phenotype of ards. it is important to be able to define responder patients from non-responders to this recruiting maneuver.

it will be a prospective interventional study in resuscitation patients with severe or moderate ards. this study will be multicentric between the university hospital of amiens and intensive care of lens, intensive care of bethune and intensive care of arras. all patients in intensive care and severe, moderate ards will be included in this study. all patients will benefit from lung ultrasound (lus) with a mapping of each lung looking for normal or pathological lung profiles, as well as a measurement of esophageal pressure (peso) at rest. a "pep titration pulmonary opening" (pep-op) test using a recruitment maneuver was then performed in all patients followed by a new lus and peso measurement.

Eligibility criteria:
inclusion criteria: will be included in the study, patients: * major patient (age ≥18 years) * controlled assisted ventilation, sedation and curarization adapted to the respirator. * within the first 72 hours of an ards (pao2 / fio2 ≤ 200 mmhg, fio2 ≥ 60% and peep of ≥5 cmh20) (as recommended by the berlin criteria) * decision of intensivist in charge of the patient to put an oesophageal probe * after hemodynamic optimization (evaluation of the preload dependence and need for catecholamines) * decision of the intensivist in charge of the patient to perform a pulmonary opening test by titration of peep by means of a pulmonary recruitment test. exclusion criteria: * patients under the age of 18 * pregnant women, women who are parturient or breastfeeding * patients with pulmonary broncho-emphysematous pathology or at risk of presenting it. * patients with a history of barotrauma or at risk of presenting it. * patients with a history of intracranial hypertension * patients with suspected or proven right ventricular dysfunction or uncontrolled hemodynamic instability after hemodynamic management. * patients with a contraindication to the placement of an oesophageal tube (esophageal surgery, severe esophageal pathology) * patients under guardianship or curatorship or deprived of liberty. * patients who are legally protected * patient not covered by french national health insurance
evaluation of the possible relationship between preeclampsia and periodontal disease

Conditions: Preeclampsia; Periodontal Disease

Summary: the primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preeclampsia. the secondary objective of the study is to analyze the relationship between preeclampsia and periodontal infection, using clinical, biochemical and microbiological methods.

preeclampsia is identified as an important cause for mother and newborn mortality. inspite of extensive research, the exact etiological relations have not been established. periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preeclampsia. it is believed that the results will set light to the etiology of preeclampsia and will help to develop strategies to prevent the disease.

Eligibility criteria:
inclusion criteria: * pregnant women with preeclampsia * 37. weeks of pregnant women with no history of preterm labor exclusion criteria: * genitourinary infection, * pregnancy or pre-pregnancy hypertension, * hiv infection, * diabetes mellitus, * multiple pregnancy, preterm labor / low birth weight, * smoker and alcohol use history, * ivf pregnancy, * placental, cervical and uterine anomalies, * pregnancy with intrauterine growth retardation, * pregnancies with congenital or chromosomal fetal anomalies, * significant vaginal bleeding, * infertility stories, * drug addicts, * poor socioeconomic level
evaluation of high-density lipoprotein in obesity study

Conditions: Obesity

Summary: obesity is associated with an impaired functioning hdl (good cholesterol) resulting in an acceleration in the development of atherosclerosis. this study will evaluate hdl functionality in patients with bmi (body mass index) 20 - 25 and bmi \>30

this study will determine if the protective function of high-density lipoprotein (hdl) is impaired in obese patients and will help to enhance cardiovascular risk prediction. carotid intima-media thickness (cimt) will be captured as a means of assessing early vascular changes associated with low hdl levels in obesity. a novel measurement for clinical correlation has also been introduced called carotid extra-medial thickness (cemt) which will be compared to cimt in this obese population.

Eligibility criteria:
inclusion criteria: * group 1: * age 20-80 * english speaking * bmi 20-25 kg/m2 * group 2: * age 20-80 * english speaking * bmi \> 30 kg/m2 * tg \> 150 and * hdl \> 50 (females) \>40 (males) * group 3: * age 20-80 * english speaking * bmi \> 30 kg/m2 * tg \> 150 and * hdl \< 50 (females) \< 40 (males) exclusion criteria: * self-reported history of: * diabetes mellitus * any previous lipid therapy within the last three months * macrovascular events including tia, stroke, myocardial infarction, heart failure, claudication, or known peripheral vascular disease * current pregnancy

Keywords: obesity hdl hdl functionality
effect of aerobic exercise in patients with essential hypertension

Conditions: Aerobic Exercise; Essential Hypertension

Summary: the goal of this observational study is to evaluate the effects of a supervised aerobic exercise training program on weight loss, functional capacity, quality of life (qol), and depression levels in patients with essential hypertension.

patients who chose the treatment type according to personal preferences were divided into two groups: group 1(n:91) exercised for six weeks, five sessions per week under the supervision of a medical doctor in the aerobic exercise laboratory, and group 2(n:47) was advised to maintain dietary habits and physical activity levels. body weight, serum lipid levels, functional capacity, qol, and depression level of all the participants were evaluated at baseline and 6 weeks later.

Eligibility criteria:
inclusion criteria: * over 18 years of age, * absence of concomitant other metabolic and cardiovascular diseases. exclusion criteria: * having suffered an event of ischaemic heart disease (\<6 months), * secondary hypertension, * hypertrophic obstructive cardiomyopathy, * congestive heart failure, * uncontrolled cardiac arrhythmia, * thyroid dysfunction, * diabetes mellitus, * symptomatic peripheral arterial occlusive disease, * aortic insufficiency or stenosis, * pulmonary or heart disease with dyspnoea at small or moderate effort, * an outbreak of orthopedic problems on hip, knee or ankles, such as arthroplasty, contracture or severe osteoarthritis, * using of antidepressant or anxiolytic drugs, * pregnancy, * cognitive disfunction.

Keywords: supervised aerobic exercise functional capacity quality of life depression level essential hypertension
safety and tolerability of intravenous administration of icvb-1042

Conditions: Patients With Advanced Solid Tumors

Summary: study to evaluate the safety and tolerability of intravenous icvb-1042


Eligibility criteria:
inclusion criteria: * adult patients with relapsed or refractory locally advanced or metastatic solid tumors who have progressed on or after at least one prior line of standard of care therapy including immune checkpoint inhibitors and targeted therapies for known molecular alterations if present * measurable disease according to recist v1.1 * ecog performance status 0 or 1 * life expectancy of at least 3 months exclusion criteria: * prior soc or other treatment with a biologic (eg, mab) within 28 days prior to dosing or 5×half-life, whichever is longer from investigational therapy * major surgical procedures within 28 days prior to dosing * limited field irradiation for palliation within 14 days prior to dosing * anti-viral agents, vaccinations within 28 days prior to dosing * known central nervous system (cns) metastases unless adequately treated and clinically stable without steroids for ≥14 days * leptomeningeal carcinomatosis * pulmonary lymphangitic spread of cancer * history of clinically significant cardiovascular abnormalities * known active infection requiring systemic antibiotic therapy or systemic antifungal therapy * known active hiv, hepatitis b or c, or other active viral disease * known hematologic malignancies (requiring or not requiring active therapy). * requirement for immunosuppressive therapy (ie, prednisone equivalent of \>10 mg/day) * women who are pregnant or lactating * oxygen saturation measured with pulse oximeter \<90% and/or on supplemental o2

Keywords: oncolytic virus first in human relapsed solid tumor refractory solid tumor tumor biopsy novel therapy metastatic previously treated
investigation of dexa-c anterior cervical interbody system

Conditions: Degenerative Disc Disease

Summary: fda cleared interbody product for the cervical spine, designed to match a patients dexa scan for increase in fusion rate.

the dexa-c cervical interbody system is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from c2-t1. device system is designed for use with supplemental fixation and autograft and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach. the dexa-c clinical study will collect data on those patients who have been treated with dexa-c anterior cervical interbody system to allow for a better understanding of outcomes associated with it.

Eligibility criteria:
inclusion criteria: 1. must already be scheduled or planned for anterior cervical discectomy and fusion using the dexa-c anterior interbody system c3-7 with supplemental fixation and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone meeting on-label criteria. 2. radicular signs and symptoms in one or both arms (i.e., pain, paresthesia or paresis in a specific nerve root distribution). 3. diagnosis of cervical radiculopathy at one or two contiguous levels from c3-7 requiring open anterior cervical fusion and discectomy. 4. diagnosis of degenerative disc disease by radiographic evidence of cervical disc herniation and/or osteophytes accompanying clinical symptoms. 5. at least 6 weeks prior conservative treatment (i.e. physical therapy, pain medication). exclusion criteria: 1. history of cervical spine surgery less than 12 months prior to surgery. 2. diagnosis of severe spondylosis. 3. patients requiring posterior cervical surgery, anterior cervical corpectomy, or revision surgery. 4. any member of a vulnerable population (ie. minors, adults who lack the ability to consent, pregnant women, etc.)

Keywords: fusion subsidence
impact of multidisciplinary and radiologic review on outcome of pancreatic cancer patients: an observational study

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: the investigators compared two different time periods respectively before and after the application of a dedicated diagnostic and therapeutic protocol for pancreatic ductal adenocarcinoma including multidisciplinary discussion and radiological review of cases, in order to evaluate the impact of the new protocol on surgical failures and overall survival.

since 2012 in reggio emilia a new diagnostic and therapeutic protocol has been implemented including multidisciplinary team discussion of non-metastatic pdacs and radiological review of ct scans by an experienced radiologist. the aim of this study is to measure the impact of this new protocol on the occurrence of surgical failures, including incomplete resection or surgery in which resection resulted impossible at all. the investigators also describe the changes in overall survival and process indicators such as the proportion of patients referred to different therapeutic options (upfront surgery, neoadjuvant chemotherapy and no surgery) and the compliance with referral. through a population-based cohort study, the investigators evaluated the impact of the new protocol on therapeutic management and surgical outcome of patients with non-metastatic pdac by comparing two four-years periods, respectively 2008-2011 and 2013-2016, before and after the introduction of the protocol. since 2012 was the transitional year when the protocol was introduced, patients diagnosed with pdac in 2012 were excluded.

Eligibility criteria:
inclusion criteria: * all consecutive inhabitants of the reggio emilia province with incident pdacs in 2008-2011 and 2013-2016 periods exclusion criteria: * pancreatic cancers with cytohistological diagnosis different from pdac, * diagnosis in 2012, * metastatic disease at diagnosis (stage iv) or unknown stage at diagnosis, * patients aged \>85 years.
screening protocol for children and adolescents with attention deficit hyperactivity disorder

Conditions: Pediatric ADHD

Summary: the objective of this protocol is to establish a comprehensive screening process to evaluate the eligibility of potential pediatric subjects for appropriate adhd clinical research studies.

the adhd clinical research program at massachusetts general hospital currently offers a range of protocols addressing different aspects of adhd in children and adolescents. although these protocols have received prior irb approval, potential participants present with a widely varied set of complaints not always discernable in a telephone screening interview. this state of affairs often makes it difficult to ask subjects and their parents to sign a specific protocol's consent form without obtaining additional clinical information. because of this, we are proposing that potential subjects and their parents undergo an in-depth clinical assessment that will allow them to be screened by a clinician for eligibility to a diverse clinical research program.

Eligibility criteria:
inclusion criteria: 1. males and females ages 6-17 2. family/guardian contacting the clinical research program in pediatric psychopharmacology, with concerns regarding adhd symptoms in his/her child exclusion criteria: 1. history of significant head trauma with loss of consciousness, organic brain disorders, seizures, or neurological intervention 2. any significant medical condition, in the judgment of the investigator 3. mental retardation 4. pregnancy or lactation 5. subjects with current, uncontrolled (within the past 3 months) illicit drug or alcohol dependence 6. sensory difficulties such as deafness or blindness

Keywords: adhd pediatric children
prospective cohort study for lymphoma: samsung lymphoma cohort study iii

Conditions: Lymphoma, Non-Hodgkin; Lymphoma, Hodgkin

Summary: this prospective study enrolls patients who are diagnosed with aggressive lymphoma including hodgkin and non-hodgkin lymphomas. enrolled patients will be treated according to our institution' treatment policy in clinical practice. the disease status including response to therapy and survival status will be regularly updated during the study period. patients' serum and cell-free dna will be collected and analyzed.

the study population is aggressive lymphomas requiring systemic chemotherapy. newly diagnosed or relapsed/refractory patients can be enrolled into the study. patients can be treated according to the principle of routine care of our institute. the study process is as follows. 1. registration after informed consent. 2. laboratory and radiological evaluation after registration including collection of serum and cell-free dna from patients' peripheral blood 3. interim and final response evaluation including collection of serum and cell-free dna from patients' peripheral blood 4. regular monitoring disease status and update of survival status 5. laboratory and radiological evaluation after relapse or progression including collection of serum and cell-free dna from patients' peripheral blood

Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed hodgkin and non-hodgkin lymphomas 2. 20 years 3. patients requiring systemic chemotherapy with curative intent 4. written informed consent exclusion criteria: 1. myeloid malignancy 2. multiple myeloma 3. patients do not require systemic chemotherapy with curative intent

Keywords: lymphoma cohort serum cell-free dna
assess the blood-oxygen-level-dependent (bold) signal changes in the brain by paracetamol as measured by functional magnetic resonance imaging (fmri) in subjects with osteoarthritis (oa)

Conditions: Osteoarthritis, Knee

Summary: blood-oxygen-level-dependent (bold) responses to painful mechanical stimulation of the oa knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. the fmri and pain assessments will occur approximately 2-5 hours after taking the final dose.

the objective of this study is to investigate if functional magnetic response imaging (fmri) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (oa) of the knee. the fmri is a harmless and painless technique that is used in the current study to collect images of brain activity to see if is changed when feeling pain. in this study, bold response to mechanical stimulation via pressure stimuli applied to the tibio-femoral joint and patello-femoral in participants with knee oa following four treatment doses of any of three treatment will be compared.

Eligibility criteria:
inclusion criteria: * diagnosis of osteoarthritis of at least one knee for 3 months * male or female at least 45 years of age * score a minimum of 4 out of 10 on the numerical pain rating and a maximum of 8 at screening exclusion criteria: * if female, is pregnant, lactating, or breast feeding * has secondary cause of knee arthritis * lower extremity surgery in the last 6 months * prior injury in the last twelve months to the index knee * used any analgesics (nsaids, cox2 inhibitor, etc) within 5 half lives of study start * recently used oral or injected glucocorticoids

Keywords: osteoarthritis pain paracetamol blood-oxygen-level-dependent functional magnetic resonance imaging
fatigue intervention trial for breast cancer survivors

Conditions: Fatigue

Summary: thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. although researchers have developed some effective interventions (exercise or group-based holistic program) to treat fatigue, none have addressed the role of the family in the patient's long-term recovery. the investigators hypothesize that a family-focused intervention in combination with a mind-body group intervention will be more effective in reducing fatigue, improving quality of life, and enhancing family relationships for breast cancer survivors than a group intervention with an individual focus.

we propose to address the persistent fatigue experienced by brest cancer survivors by using a 10 week group-based mind body medicine intervention that includes the family in the process. we believe that this family-centered approach can facilitate better communication, create shared illness experience and relieve conflict. reducing this pervasive source of stress will not only reduce the survivor's fatigue, but also foster an opposite family dynamic with positive effects in many other aspects of post-treatment recovery. we will compare the effectiveness of a 10 week group intervention to a 10 week group intervention that includes a family focus. breast cancer survivors with moderate to severe fatigue will be randomly assigned to one of the two groups and we will measure change in fatigue, quality of life, mood and social support from baseline to end-of-program and then two and six months after program completion.

Eligibility criteria:
inclusion criteria: * stage i-iii breast cancer * at least 3 months since last breast cancer treatment (excluding hormonal therapy or herceptin). * 4 week history of persistent moderate to severe fatigue * competent to sign informed consent * willing to be randomized exclusion criteria: * metastatic breast cancer

Keywords: fatigue breast cancer behavioral research quality of life
a regulatory post-marketing surveillance (rpms) study to evaluate the safety and effectiveness of saxenda®(liraglutide 3.0 mg) in obese patients and overweight patients with obesity-related comorbidities in routine clinical practice in korea.

Conditions: Obesity; Overweight

Summary: the purpose of this study is to collect information about the safety and effectiveness of saxenda® in obese patients and overweight patients with obesity-related comorbidities. the participant will attend the clinic or hospital according to usual practice and receive medical care, as agreed with the study doctor. the participation is expected to be approximately for 26 weeks.


Eligibility criteria:
inclusion criteria: - the decision to initiate treatment with commercially available saxenda® has been made by the patient/legally acceptable representative (lar) and the physician before and independently from the decision to include the patient in this study - informed consent obtained before any study-related activities study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - male or female of native korean, age greater than or equal to 18 years who is scheduled to start treatment with saxenda® based on the clinical judgment of physician as specified in the korean-prescribing information (local label) exclusion criteria: - patients who are or have previously been on saxenda® therapy - known or suspected hypersensitivity to saxenda® , the active substance or any of the excipients - previous participation in this study. participation is defined as having given informed consent in this study - treatment with any investigational drug within 30 days prior to enrolment into the study - female patient who is pregnant, breast-feeding, or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by korea regulation or practice) - mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation