Kornimate/medical-research-clean huggingface dataset:
interstitial fluid in the development of cardiovascular disease

Conditions: Type2 Diabetes; Atherosclerosis

Summary: at a given level of serum cholesterol, patients with t2d have an increased risk of developing atherosclerosis compared with nondiabetic subjects. in a previous study we showed that the interstitial fluid-to-serum gradient of ldl and vldl cholesterol is reduced in t2d patients compared with healthy controls. this was not found for hdl cholesterol. however, the cholesterol transporting function of hdl particles from interstitial fluid from patients with t2d were lower than in healthy controls. we hypothesize that that the apo b-containing particles in t2d patients are more susceptible to be retained or consumed in the extravascular space. we are to study if skin biopsies from t2d patients contain more cholesterol than biopsies from healthy controls. we hypothesize that samples from t2d patients are richer in cholesterol, which could explain why vldl and ldl cholesterol are lower in relation to their plasma levels in t2d.


Eligibility criteria:
inclusion criteria: * over 18 years. * for the t2d study group: diagnosed with type 2 diabetes. exclusion criteria: for subjects with type 2 diabetes: * systemic inflammatory disease that requires active treatment * thyroid disease that requires active treatment * skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated * treatment with oral glucocorticoids * levels of sr, tsh, t4 or hemoglobin in the blood pronouncedly outside the reference range * pregnancy for healthy controls: * registered disease in the health declaration that requires continuous systemic treatment. exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic * skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated * blood pressure pronouncedly above 140/90 * blood test results pronouncedly outside the reference range * pregnancy

Keywords: cholesterol interstitial fluid
neutrophil to lymphocyte ratio (nlr) and platelet to lymphocyte ratio (plr) as an inflammatory markers to predict length of hospital stay after total laparoscopic hysterectomy (tlh) for benign indications

Conditions: Inflammation; Hospital Stay; Total Laparoscopic Hysterectomy

Summary: due to short hospital stay, rapid return to work, less pain, and good cosmetic results, laparoscopic hysterectomy ( lh) has substantially increased the era of hysterectomy procedures especially for the last two decades. the main reason for this is probably that lh leads to fewer inflammatory responses when compared to open abdominal hysterectomy. although the inflammatory response is supposed to be lower with total laparoscopic hysteroscopy (tlh), unpredictable inflammatory response as a result of the operation has been still unenlightened and it can be associated with hospital stay.

iinflammatory response after surgery is an ordinary outcome which ends up with tissue repair. the increase in neutrophil levels accompanied with a decrease in lymphocyte levels is characteristic for the inflammatory response. therefore, neutrophil to lymphocyte ratio (nlr) comes out as a simple index of inflammation. in the literature, nlr was shown not only to be associated with surgical complications but also the length of hospital stays in certain surgeries. another inflammatory marker index of hemogram is the platelet to lymphocyte ratio (plr). as a result of endothelial tissue damage, platelets are gathered in the affected area. therefore, an increase in the number of platelets is inevitable for inflammation. hence, plr appears to be another simple index of inflammation due to the increase of platelets and the decrease of lymphocytes. plr has also shown to be associated with length of hospital stay in various surgeries. nlr and plr are both newly recommended inflammatory markers to estimate the prognosis of surgical treatment in clinics. investigations regarding nlr and plr concerning prognosis of patients after surgeries including gynecological cancer, cardiac surgeries, and emergency surgeries are available in prior literature. investigators aimed to investigate the possible effects of inflammatory parameters, that can be easily obtained from complete blood count in the post-operative first day of total laparoscopic hysterectomy, to the length of hospital stay in patients without any complications.

Eligibility criteria:
inclusion criteria: * patients whom have undergone tlh exclusion criteria: * ureter injury * bladder injury, * bowel injury, * superficial inferior mesenteric artery injury * vaginal cuff hematoma * vaginal cuff dehiscence * endometriosis * endometrial cancer * cervical cancer * chronic lymphocytic leukemia * behçet disease * electrolyte imbalance * thyroid disease * using anti-inflammatory medications * having severe intraabdominal adhesions
pain measurement in healthy volunteers

Conditions: Healthy; Pain

Summary: this study will attempt to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in patients. normal healthy volunteers and dental patients undergoing third molar extraction may be eligible for this study. participants will undergo the following procedures: volunteers: volunteers will participate in two 90-minute sessions in which they will receive and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes. the heat stimuli range from 37° (degree)c to 51° (degree)c (99° (degree) f to 124° (degree) f) and last 2 to 3 seconds. a drug commonly used in dental treatments may be administered during the second session. this will be either a maximum of 0.15 mg fentanyl, a short-acting narcotic pain killer, or a maximum of 5 mg saline, an inactive substance (placebo). dental patients: dental patients will participate in two 60-minute sessions. the first session will be on the day before the third molar extraction, and the second session will be immediately before the dental procedure. the heat stimulus procedure will be identical to that described above for normal healthy volunteers.

mismanaged pain is still a major medical problem. many pain syndromes have no effective treatment, and many are managed poorly. basic and applied research on pain treatment is hampered by the unobservable nature of pain sensation and the lack of validated measures of this perception. the purpose of this protocol is to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in clinical populations. normal volunteers rate experimentally-evoked pain sensations before and after double-blind administration of the opioid fentanyl or saline placebo. patients rate experimentally-evoked pain sensations without any drug administration.

Eligibility criteria:
normal volunteers, including nih employees, will serve as subjects. no subjects with any painful disease or diseases in which altered pain sensitivity is suspected. no subjects will be included with poor general health, history of significant illness, history of psychotic disorder or recent emotional distress, serious heart, lung, or liver disease, or pregnancy. subjects also will be excluded on the basis of history of allergy to any of the medications, history of chronic or recent drug use that may alter pain response, or chronic drug abuse.

Keywords: psychophysics validation fentanyl normal volunteer pain
convalescent plasma for treatment of covid-19: an exploratory dose identifying study

Conditions: COVID-19

Summary: convalescent plasma has been shown to be safe and effective for treatment of several diseases. preliminary data indicates that it is safe and effective for treatment of covid. however, data is limited to small studies and case series on severely ill patients. in a preliminary safety study 10 patients with severe covid-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of cp. cp was given as a slow infusion without obvious adverse events. eight patients had viremia. one patient rapidly cleared the virus and recovered following cp treatment. cp infusion did not appear to clear viremia in 7/8 patients. five of these were eventually admitted to icu. thus cp did not appear to cause acute toxicity but did not seem to be effective at the dose used. viremia seemed to be a marker of a high risk of disease progression the proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving covid-19.


Eligibility criteria:
inclusion criteria: * age 18 or older * admitted to a study hospital * active covid-19 defined as symptoms + sars cov-2 identified from upper or lower airway samples * negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential * written informed consent after meeting with a study physician and ability and willingness to complete follow up exclusion criteria: * no matching plasma donor (exact matching in both the abo system is required) * unavailability of plasma * significant growth of alternative lower airway pathogen such as streptococcus pneumoniae or haemophilus influenzae in sputum * estimated glomerular filtration rate \<60 (kidney failure stage iii or more) * pregnancy (urinary-hcg) * breast feeding * history of severe allergic reactions to foods or other substances that the donor may have been exposed to (for example severe peanut allergy) * inability to give informed consent

Keywords: covid-19 convalescent plasma treatment sars-cov-2 infection dosing safety effectiveness
study to evaluate symptoms of exocrine pancreatic insufficiency in adult participants with cystic fibrosis or chronic pancreatitis treated with creon

Conditions: Cystic Fibrosis; Chronic Pancreatitis

Summary: exocrine pancreatic insufficiency (epi) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (cf), chronic pancreatitis (cp), and pancreatic cancer. this study will assess clinical symptoms when participants with cf or cp are treated with creon with alternate source of active drug. creon is an approved drug for the treatment of epi. this study is subject-blinded which means participants will not know the source of the study drug they are given. approximately 30 adult participants with cf or cp will be enrolled at approximately 15 sites across the unites states. participants will receive oral capsules of creon for 113 days and will be followed for 30 days. participants will attend regular visits during the study at a hospital or clinic or via telemedicine. the effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * previous diagnosis of cystic fibrosis (cf) or chronic pancreatitis (cp). * previous diagnosis of exocrine pancreatic insufficiency (epi) that is currently clinically controlled. * total symptom score (tss) \< 1.8 on pancreatic exocrine insufficiency questionnaire (pei-q) at screening. exclusion criteria: - malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with epi symptom assessment.

Keywords: cystic fibrosis chronic pancreatitis exocrine pancreatic insufficiency creon pancrelipase
safety, efficacy and quality of life of sphinkeeper implantation for fecal incontinence

Conditions: Fecal Incontinence

Summary: this study evaluated a treatment called sphinkeeper™ implantation for people suffering from fecal incontinence, a condition where individuals are unable to control their bowel movements. the procedure involves placing small expandable devices into the anal sphincter area to help improve muscle function and prevent leakage. researchers from several european hospitals followed 111 patients over three years to assess how safe and effective this treatment is, and how it affects quality of life. most patients had not improved with other treatments like diet, medications, or pelvic floor therapy.


Eligibility criteria:
inclusion criteria: * adults diagnosed with clinical fecal incontinence (fi), defined as experiencing at least one incontinence episode per week for a duration exceeding six months. * refractory to all standard conservative treatments, including: * pharmacologic therapy * behavioral interventions * pelvic floor rehabilitation * endoanal ultrasonography indicating: * intact internal and external anal sphincters, or * internal, external, or combined sphincter defects involving no more than 120 degrees of the anal circumference. exclusion criteria: * presence of inflammatory bowel disease with anorectal involvement. * diagnosis of anorectal cancer. * evidence of perianal sepsis. * endoanal ultrasound detection of sphincter defects extending over more than 120 degrees of the internal or external sphincter, or both. * prior treatment with sacral neuromodulation.
effects of cocoa flavanol on skin aging

Conditions: Ageing; Photo-aging

Summary: photoaging is caused by the superposition of chronic ultraviolet (uv)-induced damage on the intrinsic aging process, and accounts for the majority of age-associated changes in skin appearance. reactive oxygen species (ros) likely contribute to this process. strategies utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have been examined. cocoa beans fresh from the tree are exceptionally rich in polyphenols, such as flavanol, and have a higher antioxidant capacity. the present study is designed to investigate the effects of long-term intake of a product rich in cocoa flavanols on facial wrinkles, hydration, elasticity and photosensitivity.


Eligibility criteria:
inclusion criteria: * healthy females aged ≥ 40 years * facial wrinkle grade ≥ 2 exclusion criteria: * received medical or cosmetic treatment that interferes with the general aging process at least 3 months before the study * reported taking functional foods 1 month before the study * history of acute or chronic disease such as severe liver or kidney disease or uncontrolled diabetes * history of allergies against any component of trial foods * any visible skin disease that might be confused with a skin reaction to the test procedure

Keywords: anti-aging high-flavanol cocoa
social & affective cognition in alzheimer's disease & associated disorders

Conditions: Alzheimer's Disease; Frontotemporal Degeneration (Semantic & Behavioral Variants)

Summary: recent studies have shown that individual neuropsychological scores of patients with alzheimer's disease and associated disorders (adad) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. recently, social \& affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. however, no previous studies have assessed the specific relationship between social \& affective cognition \& social behavior in adad. our pilot study aims to explore the correlations between core and extended social \& affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains.


Eligibility criteria:
inclusion criteria: * men and women; * 40 to 85 years of age (included); * registered with the french social security; * have a study partner. the study partner is required to complete several scales. if the subjects or their study partners are not able to drive, their transport fees will be reimbursed by the promotor. * fluent in french, able to read and write; exclusion criteria: * participants who have contraindications to perform an mri scan; * participants with significant sensory deficits that are not corrected by suitable devices. * participants with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load, in the judgment of the investigator; * participants with other neurodegenerative disease such as lewy body dementia and parkinson's disease; * participants with other serious neurological disorder such as brain tumor, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study; * participants with excessive alcohol intake or drug abuse, in the judgment of the investigator; * participants who, in the opinion of the investigator, have a risk of non-compliance to the study procedures;

Keywords: emotions social cognition social semantics neuropsychology frontotemporal dementia
real-time atherosclerosis activity after thoracic radiotherapy using sodium fluoride positron emission tomography

Conditions: Oligometastatic Disease

Summary: the prospective single-arm pilot study, athero-rt: real-time atherosclerosis activity after thoracic radiotherapy using sodium fluoride positron emission tomography, will aim to: 1. to deploy first-in-kind application of fluorine 18-sodium fluoride (18f-naf) pet (positron emission tomography) /mri (magnetic resonance imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure 2. to detect longitudinal changes in clonal hematopoiesis (ch) genetic architecture following thoracic rt (radiation therapy) in patients at high risk of cardiac dysfunction, and 3. to measure perturbations in the immune-modulatory and metabolic states following thoracic rt (radiation therapy) exposure in patients at high risk of cardiac dysfunction. eligible patients will be adults (≥18 years old) with stage ii-iii or oligo-metastatic stage iv malignancy (any histology) at high risk for rt-associated cardiac toxicity (defined as receiving ≥30 gy (gray) rt where the heart is in the treatment field54). the study will enroll a total of 10 subjects, recruited from cedars-sinai medical center. the primary endpoint will be successful completion of 18f-naf pet imaging at the baseline and 6-month post-rt time points. blood will be collected at baseline, end of rt, and 6-months post-rt.


Eligibility criteria:
inclusion criteria * age ≥ 18 years. * have clinical stage ii-iii or oligo-metastatic stage iv malignancy (any histology) planned to be treated with thoracic radiotherapy (≥30 gy) where the heart is in the treatment field. * eastern cooperative oncology group (ecog) performance status (ps) of 0-2. * planning to receive standard of care radiotherapy treatment. * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * ability to read, write, and understand english exclusion criteria * estimated glomerular filtration rate (egfr) \<45 ml/min/m2 or serum creatinine ≥1.5 mg/dl. * patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and/or 18f-naf tracer. * inability to receive pet tracer. * inability to receive mri, requiring sedation for mri, or prohibitive implant and/or device, including ferromagnetic implants and ferromagnetic foreign bodies. * subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine. * subjects that are pregnant or breastfeeding. * subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions. * allergy to animal dander or animal-instigated asthma. * any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial

Keywords: thoracic radiotherapy pet imaging mri imaging 18 f-naf clinical stage ii clinical stage iii
evaluation of the efficacy and safety of the facet fixation implant.

Conditions: Degenerative Lumbar Spinal Stenosis

Summary: this is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the facet fixation implant. the main objective is to evaluate the efficacy of the facet fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative ct-scan at over 2 years.

the primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old at the time of the surgery * the first back operation in the patient's life was for degenerative lumbar spinal stenosis * surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with pedicle screw fixation or facet fixation implant. * patient is able to understand the information related to the study * patient consents to participate to the clinical investigation and agrees (non-objection) on the use of his/her personal data. exclusion criteria: * patient received facet fixation implant or pedicle screw fixation with supplemental interbody cages. * unilateral pedicle screw or facet fixation implant. * preoperative grade ≥ii spondylolisthesis * preoperative scoliotic deviations \>25°. * protected patient (under legal protection, deprived of liberty by judicial or administrative decision). * patient not covered by a social security scheme.