Kornimate/medical-research-clean huggingface dataset:
observational evaluation of the peristomal skin condition in ostomates

Conditions: Ostomy

Summary: the purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.


Eligibility criteria:
inclusion criteria: * subjects who are 18 years old and older. * subjects who agree to participate in the evaluation and who have signed the informed consent form. * subjects presenting with a stoma (ileostomy, colostomy or urostomy). * subjects for whom a convatec moldable technology™ skin barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin. or * subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with convatec moldable technology™ skin barrier per package insert is made in the context of routine clinical care. exclusion criteria: * subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem. * subjects who are in a simultaneous clinical evaluation.

Keywords: ostomy peristomal skin breakdown convatec moldable skin barriers
safety and efficacy of meplazumab in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: the development of coronary atherosclerosis is closely related to inflammation, and cd147 may play an important role in its process. the present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-cd147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.


Eligibility criteria:
inclusion criteria: 1. patients with chronic coronary syndrome 2. non-target lesions with stenosis ≥50% by visual assessment 3. angina symptoms manageable via antianginal medication 4. high attenuation coefficient (≥-70.1 hu) of perivascular adipose tissue (pvat) around non-target lesions as assessed by coronary ct angiography (ccta) 5. patients who are able to complete the follow-up and compliant to the prescribed medication exclusion criteria: 1. under the age of 18 2. unable to give informed consent or currently participating in another trial and not yet at its primary endpoint 3. patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice) 4. concurrent medical condition with a life expectancy of less than 3 years 5. haemodynamical unstable 6. known contraindications to medications such as test drug and its components, heparin, or contrast 7. the following criteria are met for any of the laboratory test indicators at the time of screening ①alt/ast \>3uln；②tbil ≥2uln；③wbc\>2uln；④neut\<0.5×109 /l；⑤plt\<30×109 /l；⑥egfr \&lt;60 ml/min/1.73 m2（ckd-epi formula） 8. suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate

Keywords: meplazumab coronary artery disease inflammation lipid deposition
estimation of sialic acid and il10 levels in stage 1 and 2 periodontitis patients

Conditions: Periodontal Disease

Summary: sialic acid (sa) is the generic term given to a family of acetylated derivatives of neuraminic acid. sa is a 9 carbon monosaccharide. an important function of host sa is to regulate innate immunity. sa is present in several acute phase proteins which are known to be associated with periodontitis. there exists a need for a biomarker, for early detection of disease evolution and more robust therapy efficacy measurements. till date, there is very little data regarding simultaneous estimation and comparison of total sa content in saliva. il-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines such as il-1, -2, -6 and stimulates protective antibody production. il-10 is expressed in both healthy and diseased human periodontal tissues and is reported to be reduced in patients infected with aggregatibacter actinomycetemcomitans. the present study was therefore undertaken with an aim, to not only assess the levels of tsa(total sialic acid levels),but also of il 10 levels in saliva from stage 1(mild) to stage 2(moderate) periodontitis patients

selection of patients by grading the patients according to criteria stage 1 and 2 periodontitis obtaining consent from patients participating in the study collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool box indicated for laboratory samples and transported to the lab for investigations. it will be centrifuged at 2500 rpm for 10 mins,stored at -80 deg c. sa(sialic acid) levels will be determined by thiobarbutic acid method of aminoff and elisa methods. sa levels will be measured in mg/dl,il10 as in direct measurement.

Eligibility criteria:
inclusion criteria: * all the subjects should be within the age group of 18 to 55 years * subject should have atleast 18 natural teeth excluding third molars. exclusion criteria: * history of periodontal debridement or periodontal surgery in preceding six months or any antimicrobial therapy, anti-inflammatory drugs. * corticosteroids, in previous three months * systemically compromised individuals * smokers * pregnant and lactating women * medical history for absence of systemic disorders such as diabetes mellitus * cardiovascular diseases * pneumonia * tuberculosis * rheumatoid arthritis

Keywords: sialic acid il10 stage 1 periodontal disease stage 2 periodontal disease
a controlled trial of mifepristone in gulf war veterans with chronic multisymptom illness

Conditions: Chronic Multisymptom Illness in Gulf War Veterans

Summary: we propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in gulf war veterans (gwv) with chronic multisymptom illness (cmi) to examine its effects on physical and mental health and cognitive functioning. in addition, we propose to examine whether hpa axis biomarkers or their response to mifepristone are useful predictors of clinical response.


Eligibility criteria:
inclusion criteria: * veteran of the 1991 gulf war * veteran meets criteria for multisymptom illness exclusion criteria: * veteran lacks the capacity to provide consent. * veteran has a major medical or neurological disorder or traumatic brain injury * veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency * veteran is taking oral corticosteroids * veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder * veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years * veteran has current suicidal ideation * veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment. * women veterans with diseases of the uterus by history or a family history of uterine cancer * known allergy to mifepristone
attention bias modification treatment for warzone-related posttraumatic stress disorder (ptsd)

Conditions: Posttraumatic Stress Disorder

Summary: veterans with posttraumatic stress disorder (ptsd) will be randomly assigned to either attention bias modification treatment (abmt) designed to reduce bias toward threat or a placebo control condition not designed to change attention patterns. outcome measures will be ptsd, anxiety, depression, and alexithymia symptoms as measured by standard psychological interviews and questionnaires. participants will also be invited to participate in physiological testing before and after receiving ambt or placebo to serve as additional outcome measures and assess brain functioning, heart rate, and muscle tension. the investigators expect to see significant ptsd symptom reduction in the attention bias modification treatment (abmt) group relative to the placebo control group in which no symptomatic relief is expected. at the end of the study, if abmt is shown to be effective, we will offer active abmt to those participants randomly assigned to the placebo arm if they would like to receive the treatment.


Eligibility criteria:
inclusion criteria: * veterans with posttraumatic stress disorder (ptsd) serving in united states military after march 20, 2003. exclusion criteria: * schizophrenia * bipolar disorder * obsessive compulsive disorder * head injury with loss of consciousness for more than 30 minutes * active alcohol/substance dependence in past 6 months

Keywords: ptsd posttraumatic stress post traumatic stress attention bias threat bias combat warzone
essential oil aromatherapy intervention

Conditions: Phobia Phlebotomy

Summary: lab sampling for clinical trial participants can be a stressful and painful experience. most trial participants will have blood drawn for lab samples at multiple study visits. the participants must fast for up to ten hours before the blood sampling, in many cases, and patients often report a painful experience if more than one venipuncture occurs. in addition, the number of collection tubes can increase the anxiety level of the patient and the phlebotomist. this project proposes to evaluate if essential oil aromatherapy results in less pain and /or anxiety when compared to usual care.

the process of drawing blood for can be painful and stressful for any patient. those patients who participate in a clinical trial agree to frequent lab sampling to monitor for effect and safety of the investigational product. the frequency is variable, from several times a day for a participant in the hospital to annually for some trials. participants have reported anxiety regarding the number of tubes to be drawn, even resulting in near syncope, and pain with the venipuncture process. the clinical trial nurses at healtheast have utilized a variety of therapeutic techniques to ease the pain and anxiety experienced by the trial subjects, such as redirection, deep breathing, hand massage and guided imagery. these techniques have not been evaluated for effectiveness in easing pain and anxiety nor have they been compared with no intervention to determine if any intervention was more efficacious in alleviating pain and/or anxiety. the primary objective of this study is determine if aromatherapy with an essential oil has a higher reported effect in anxiety and pain relief with venipunctures than standard of care (no therapy) among participants in healtheast clinical trials office studies. secondary objectives include comparing the number of venipunctures and blood collection tubes in the treatment arms. this is a randomized, open label, prospective single site study designed to determine the effect of essential oil aromatherapy compared to usual care on pain and anxiety associated with venipunctures for clinical trial participants in the healtheast heart care clinic.

Eligibility criteria:
inclusion criteria: 1. must be at least 18 years of age 2. must be currently participating in a clinical trial at healtheast exclusion criteria: 1. known allergy to any of the oils used for aromatherapy 2. less than age 18 3. declined to participate
cooling solutions for outdoor workers

Conditions: Hyperthermia; Heat Acclimation and Thermotolerance

Summary: the investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers.

workers in a variety of us industries-construction workers, welders, farmers, firefighters, and warehouse workers among them-are at risk for hyperthermia during work, yet very few interventions are being developed to mitigate heat related organ injury, particularly when workers do not have obvious symptoms of heat related illness. the investigators plan to test whether two active cooling technologies can help mitigate hyperthermia and risk for kidney injury. this work will enhance worker safety using evidence-based technology. to accomplish the aims of testing two active cooling interventions, the investigators plan to implement a case-cross over randomized control trial design at the work site conducted in partnership with an employer and with 30 workers at risk for hyperthermia. over three sequential weeks, the investigators will measure rate of core temperature change (primary outcome). secondary outcomes will include changes in kidney injury markers; changes in worker productivity; and worker acceptability of interventions.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. anticipated to be working in the same job category for the duration of the study 3. able to communicate in english or spanish exclusion criteria: 1. cannot provide informed consent 2. weight less than 40 kg 3. inability to swallow pills 4. known history of having a pacemaker or icd 5. pregnancy as determined by self report and confirmed on day 1 6. gastrointestinal disorders (e.g., gastroparesis, prior surgery on gi tract with the exception of appendectomy or cholecystectomy, diverticulosis or inflammatory bowel disease) 7. plan for an elective mri in the 7 days post last planned pill ingestion

Keywords: outdoor work heat stress kidney injury cooling interventions
safety and efficacy of long-term somatropin treatment in children

Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Foetal Growth Problem; Small for Gestational Age; Genetic Disorder; Turner Syndrome; Growth Disorder; Idiopathic Short Stature

Summary: this study is conducted in europe. the aim of this study is to evaluate safety during the long-term use of somatropin (norditropin®) in children as well as efficacy on change in height. a subgroup of children small for their gestational age is included.


Eligibility criteria:
inclusion criteria: * in need of somatropin or current user
clinical results of small incision lenticule extraction (smile) for the correction of high myopia

Conditions: Myopia; High Myopia

Summary: small incision lenticule extraction (smile) was introduced in 2011 using the visumax femtosecond laser (carl zeiss meditec, jena, germany). it is designed for correction of myopia and myopic astigmatism. it involves the creation of a corneal tissue disk called lenticule and its extraction through a minimally invasive incision, utilizing only a femtosecond laser. this enables rapid visual recovery with very little discomfort to the patient. this observational case series monitors visual and refractive outcomes of myopic correction for more than -7.75 d. it is to * gather long-term results and refractive stability * detect rare complications or side-effects * evaluate the efficacy in a large number of patients


Eligibility criteria:
inclusion criteria: * adults * myopia more than -7.75 d * refractive stability more than 1 year exclusion criteria: * corneal irregular astigmatism * ectatic conditions

Keywords: myopia refractive surgery small incision lenticule extraction smile
effects of dash diet on corticosteroids medication use

Conditions: Nutritional and Metabolic Disease

Summary: to determine the effects of the dietary approaches to stop hypertension (dash) diet on the metabolic side effects of corticosteroids medications use.

objective: to determine the effects of the dietary approaches to stop hypertension (dash) diet on the metabolic side effects of corticosteroids medications use. design: a randomized clinical trial was undertaken in 60 patients on corticosteroid therapy for 10 weeks. patients were randomly assigned to a dash or control diet. fasting blood sample were measured to determine blood glucose and lipid profile. blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility criteria:
inclusion criteria: * patients who were on corticosteroid therapy exclusion criteria: * refuse to follow the visits
hyperpolarized carbon c 13 pyruvate magnetic resonance spectroscopic imaging in detecting lactate and bicarbonate in participants with central nervous system tumors

Conditions: Malignant Central Nervous System Neoplasm; Metastatic Malignant Neoplasm in the Central Nervous System

Summary: this early phase i trial studies how well hyperpolarized carbon c 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. hyperpolarized carbon c 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.

primary objectives: i. to assess the safety of intravenous (iv) injection of hyperpolarized carbon c 13 pyruvate (hyperpolarized \[1-13c\] pyruvate) for magnetic resonance imaging (mri). ii. to assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after iv injection of hyperpolarized \[1-13c\] pyruvate. outline: participants undergo mri over 45 minutes at baseline. participants then receive hyperpolarized carbon c 13 pyruvate iv over 30-40 seconds. within 1 minute, participants undergo magnetic resonance spectroscopic imaging (mrsi) over 3 minutes and mri over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). after completion of study, participants are followed up periodically.

Eligibility criteria:
inclusion criteria: * patients with a known diagnosis of central nervous system (cns) malignancy, including metastases, with known enhancement on magnetic resonance (mr) who are otherwise eligible to undergo mri * glomerular filtration rate (gfr) \> 30 ml/min * no allergy to gadolinium * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * refusal to have an iv placed for injection * acute major illness (e.g., unstable angina, etc.) or other condition that makes participation unsafe, per the investigator?s judgement * total bilirubin \> 1.5 x upper limit of normal (uln) * aspartate aminotransferase (ast)/alanine aminotransferase (alt) \> 2.5 x uln * gamma-glutamyltransferase (ggt) \> 2.5 x uln * pregnant or breast-feeding * cardiovascular risk, including: * poorly controlled hypertension, defined as either systolic \> 170 or diastolic \> 110 * congestive heart failure * myocardial infarction within the past year * qt prolongation, defined as pretreatment corrected qt interval (qtc) \> 440 msec in males or \> 460 msec in females
immune response of patients with chronic, staphylococcus aureus-infected wounds

Conditions: Diabetic Foot; Foot Ulcer; Leg Ulcer; Bacteremia; Infection

Summary: the primary objective of this study is to detect differences in anti-s. aureus antibody assays (igm, iga, igg and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of patients with localized chronic wound infections (control).

secondary objectives include: * to propose a diagnostic marker of bacteraemia based on the detection of anti-s. aureus by xmap technology * to evaluate the kinetics of the humoral immune response to s. aureus in patients with bacteraemia * to evaluate the virulence of s. aureus isolated from chronic, infected wounds * to enrich the nîmes university hospital biobank * to evaluate the prevalence of different antibodies within each group

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 6 months of follow up * patients consulting at the departments of diabetology, dermatology or infectious diseases of the participating hospitals * inaugural or recurrent diabetic foot/ankle ulcers of grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed. controls: * absence of bacteriemia cases: * presence of bacteriemia exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient does not have a chronic wound * patient with grand 1 ulcer * patient's wound/ulcer is not infected * patient's would/ulcer is infected, but not involving s. aureus

Keywords: s. aureus
a study to determine the safety, tolerability and efficacy nw-3509a in patients with chronic schizophrenia

Conditions: Chronic Schizophrenia

Summary: a 4-week phase iia study to evaluate the safety and tolerability and efficacy of nw-3509a in patients with chronic schizophrenia that are not responding adequately to their current antipsychotic medication (aripiprazole or risperidone). nw-3509a is given as an oral dose range of 15 to 25 mg, bid in a 1:1 ratio.

this is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed to evaluate the safety, tolerability, and preliminary efficacy of an oral dose range of nw-3509a of 30 to 50 mg/day (15 to 25 mg, bid) in patients with chronic schizophrenia on a stable dose of an antipsychotic (aripiprazole or risperidone). a minimum of 90 patients will be randomized in a 1:1 ratio to receive either nw-3509a (n=45) or placebo (n=45). dose increases will be performed only during in-patient setting. safety and efficacy assessments will be done on a weekly basis during the randomized treatment period. the assessment of safety will be based on laboratory tests (biochemistry, hematology, and urinalysis), 12-lead standard ecg, vital signs, physical examinations, neurological examinations, c-ssrs, esrs-a, subjective reporting of any ae by the subject, objective observation of any ae by the investigator. pharmacokinetic samples will be taken at various time-points. efficacy assessments will include the panss, cgi-c, cgi-s and the strauss-carpenter level of functioning (lof) scale.

Eligibility criteria:
inclusion criteria: 1. male/female; if female, must not of childbearing potential 2. 18 to 65 years of age, inclusive; 3. has a current diagnosis of schizophrenia 4. has a total score on the panss \< 75. 5. positive symptoms sub-scale score not to exceed 15; score of ≥4 on no more than 2 positive symptoms 6. has a clinical global impression - severity of disease (cgi-s) rating of mildly to moderately severely ill. 7. is in need of anti-psychotic treatment and is currently receiving a stable dose (minimally for 4 weeks prior to screening of oral risperidone or aripiprazole (at least 2 mg risperidone dose-equivalent). 8. current symptoms present for at least one month. 9. patient agrees to be hospitalized for up to 2 days at the start of dosing and at each dose increase