Kornimate/medical-research-clean huggingface dataset:
cp376 oct exploratory skin study

Conditions: Stoma Ileostomy

Summary: an explorative study investigating differences on the peristomal skin and the abdominal skin by optimal coherence (oct) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled. the investigation consists of 2 visits, a screening visit (v0) and a baseline/test visit (v1). v1 will also terminate the study period .the total study duration will be extended to a maximum of approximately 1 week, depending on the interval between v0 and v1.

an explorative study investigating differences on the peristomal skin and the abdominal skin by optimal coherence (oct) 12 subjects with an ileostomy using a flat 1-piece open ostomy device will be enrolled. subjects will use their standard of care ostomy device as intended and remove the device at the test visit. the investigation consists of 2 visits, a screening visit (v0) and a baseline/test visit (v1). v1 will also terminate the study period when the oct scan and other skin measurements has been completed. the total study duration will be extended to a maximum of approximately 1 week, depending on the interval between v0 and v1. the oct scans and other skin measurements (tewl, hydration and erythema measurements) will be performed on the skin when the ostomy device has been removed.

Eligibility criteria:
inclusion criteria: 1. has given written informed consent 2. is at least 18 years old 3. has full legal capacity 4. has an ileostomy 5. is using a flat 1-piece open ostomy device 6. have had the ileostomy for a year exclusion criteria: 1. is currently receiving or have within the past two months received radio-and/or chemotherapy 2. is currently receiving or have within the past month received steroid treatment in the skin area used in the investigation, e.g. lotion, spray, injection or tablet 3. is pregnant or breastfeeding
study on prescribers' knowledge and understanding of safety messages following dengvaxia® product information update

Conditions: Dengue Virus Infection

Summary: the primary objective of the study is to evaluate the effectiveness of additional risk minimization measures material by assessing the knowledge and understanding of healthcare professionals regarding the key safety messages provided in the material. the secondary objective of the study is to evaluate if healthcare professionals know dengvaxia product information, namely, age indication and contraindications.

the study is a cross-sectional survey. study data are collected through a questionnaire.

Eligibility criteria:
inclusion criteria: - healthcare professionals who are current or past prescribers of dengvaxia exclusion criteria: * healthcare professionals who have never prescribed dengvaxia * healthcare professionals who may have a conflict of interest with the survey (i.e. healthcare professionals employed by regulatory bodies, pharmaceutical industries) * healthcare professionales who have participated in testing the questionnaire for comprehensibility, consistency and the appropriateness of medical terms the above information is not intended to contain all considerations relevant to participation in the survey.
use of psychologist-administered cognitive behavioral therapy (cbt) or self-administered cbt for the treatment of anxiety and/or depression in inflammatory bowel disease (ibd)

Conditions: Crohn Disease; Ulcerative Colitis (UC)

Summary: this is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with ibd can be improved with cbt compared to those treated with sky.

this is a prospective, single center, randomized treatment study, where participants will be screened for anxiety and depression in an inflammatory bowel disease (crohn's disease and ulcerative colitis) population using the generalized anxiety disorder (gad) questionnaire and the patient health questionnaire (phq). participants with gad scores of ≥8 will be considered to have anxiety and those with a phq score of ≥10 will be considered to have depression. all participants with screening questionnaire scores positive for anxiety or depression will be randomized to treatment with either cognitive behavioral therapy (cbt) with a clinical psychologist (virtual visits) or cbt using a book written for ibd patients. the gad and phq surveys will be repeated post treatment at weeks 6, 12 and 24. the primary objective of this study is to assess for an improvement in gad and phq scores among subjects treated with cbt comparing 2 modalities of cbt. the secondary objectives are to assess for improvements in health-related quality of life, based on short ibd questionnaire scores; assess for improvement in pain scores, based on the brief pain inventory short form; and assess for improvement in fatigue scores based on the facit-fatigue scale, among subjects with poor scores at baseline following treatment with cbt.

Eligibility criteria:
inclusion criteria: * verified inflammatory bowel disease (crohn's disease and ulcerative colitis) * ibd patients on a stable treatment regimen with no evidence of active intestinal inflammation based on either normal c-reactive protein and/or fecal calprotectin, imaging studies, or endoscopy who meet the criteria for anxiety or depression based on the screening questionnaires * subjects who have been on stable doses of anxiety and/or depression medications (defined as no dose adjustment in the prior 12 weeks) at the screening visit who meet the criteria for anxiety and/or depression based on screening questionnaires and are willing to stay on the same dose of these medications throughout the study duration * may meet the criteria for both anxiety and depression and cohort assignment will be based on the survey with the highest scores suggesting more severe symptoms exclusion criteria: * declines to participate for the full duration of the study * evidence of active intestinal inflammation based on an elevated c-reactive protein and/or fecal calprotectin, imaging studies or endoscopy * non-english speaker * any subject who expresses suicidal ideation or has severe mental illness as they will be taken to the emergency room for urgent psychiatric care

Keywords: anxiety, depression
a study to evaluate risankizumab in adults and adolescents with moderate to severe atopic dermatitis

Conditions: Dermatitis

Summary: the purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (ad) in adults and adolescents.

this study includes a screening period of up to 35 days, a 16-week double-blind treatment period (period a), and a 36-week double-blind treatment period (period b). participants who meet eligibility criteria will be randomized at baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. randomization will be stratified by baseline disease severity (validated investigator global assessment scale for atopic dermatitis \[viga-ad\] score of moderate \[3\] versus severe \[4\]) and geographic region (japan versus rest of world). at week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.

Eligibility criteria:
inclusion criteria: * adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old * a diagnosis of atopic dermatitis (ad) with onset of symptoms at least 2 years prior to baseline and subject meets hanifin and rajka criteria * moderate to severe ad at the baseline visit * history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments exclusion criteria: * prior exposure to any biologic immunomodulatory agent or janus kinase (jak) inhibitor * concurrent treatment with systemic therapy for ad (biologic or non-biologic) or topical and/or phototherapy treatments

Keywords: atopic dermatitis, atopic dermatitis (atopic eczema)
the role of mri in evaluation of low back pain

Conditions: Low Back Pain

Summary: this study aims to evaluate the role of mri to diagnose different causes of low back pain among middle aged females at sohag university hospital.


Eligibility criteria:
inclusion criteria: - middle aged female patients aged from 40 to 60 years with complaints of low back pain who were referred to the department of radiology of sohag university hospital for lumbosacral spine mri. exclusion criteria: * male patients. * female patients aged less than 40 years or more than 60 years. * contraindication to magnetic resonance imaging including cochlear implant, pacemaker, claustrophobia. * non-cooperative sick patients.
pseudoexfoliation syndrome in myopes

Conditions: Pseudoexfoliation Syndrome in Cataract Myopic Eyes

Summary: a retrospective study of 5753 eyes of cataract surgery patients was conducted at our clinic. ocular optical components measured by optical low coherence reflectometry biometer lenstar ls 900® of the cataract myopic eyes with pseudoexfoliation syndrome were put in comparison with those of cataract myopic eyes group without pseudoexfoliation syndrome.

a retrospective study of 5753 eyes of cataract surgery patients was conducted at investigators clinic in a period of 2.5 years. pseudoexfoliation syndrome was found in 255 eyes. there were only 26 cataract myopic eyes with pseudoexfoliation syndrome. refractive eye state was defined by preoperatively calculated emmetropization intraocular lens (iol) value done by optical low coherence reflectometry biometer lenstar ls 900®. ocular optical components of the cataract myopic eyes with pseudoexfoliation syndrome measured by this biometer were put in comparison with matched cataract myopic eyes group without pseudoexfoliation syndrome that have emmetropization iol value within the same range as the cataract myopic eyes with pseudoexfoliation syndrome.

Eligibility criteria:
inclusion criteria: * cataract surgery patients ≥ 40 years old exclusion criteria: * cataract surgery patients \< 40 years old

Keywords: myopia pseudoexfoliation syndrome optical low coherence reflectometry ocular optical components cataract
evaluation of efficacy of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers

Conditions: Weight Loss

Summary: the purpose of this study is to assess the efficacy and safety of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers, versus placebo, after 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * 27 ≤ bmi ≤ 35 kg/m² * abdominal obesity * acceptance to adhere to diet and physical activity recommendations while maintaining global lifestyle habits * stable body weight (\<5% variation) within the last 3 months prior to screening exclusion criteria: * allergy to nuts and products thereof and allergy to mango fruit * type i or ii diabetes * smokers * severe chronic diseases * history of bariatric surgery and eating disorders * use of weight management products or medications which could affect nutrients absorption, lipids or carbohydrates metabolism

Keywords: weight management cashew apple extract overweight
circulating circrna in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: crast is to analyze the expression pattern of circular rna (circrna) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. the candidate circrna will be verified as biomarkers for the detection and prognosis of acute ischemic stroke.

circular rnas have been highlighted to be involved in the pathological process of ischemic stroke (is). the purpose of this protocol will investigate the expression pattern of circular rna (circrna) by bioinformatics analysis in patients with acute ischemic stroke and healthy control. the candidate circrna will be verified as biomarkers for the detection and prognosis of acute ischemic stroke. distinctive expression patterns of circrna will be identified by individual quantitative real time polymerase chain reaction (qrt-pcr). a diagnostic or predictive model will be established using logistic regression. the panel of these altered circrnas may be associated with acute is and could serve as a novel diagnostic or predictive method.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * confirmed acute ischemic stroke by a diffusion-weighted imaging-position lesion on magnetic resonance imaging (mri) and a new lesion on a brain computed tomography (ct) scan * within 72 hours of symptom onset * good performance status * signed an approved informed consents exclusion criteria: * a history of hemorrhagic infarction, chronic kidney/liver diseases, peripheral arterial occlusive disease, active malignant disease, and inflammatory or infectious diseases

Keywords: circrna
effect of orthokeratology on myopia progression in french children

Conditions: Myopia Progression

Summary: to evaluate and to compare the effect of orthokeratology (ok) on axial elongation in french myopic children.


Eligibility criteria:
inclusion criteria: * 7 to 17 years old * myopia between 0,50 d and 7.00 d * astigmatism ≤ 4.00 d with-the-rule 180+-20 * anisometropia ≤ 1.50 d * myopia evolution ≥ 0.25 d over 6 months * best-corrected visual acuity (bcva) ≥ 20/20 (snellen equivalent) * follow-up period \> 6 months exclusion criteria: * prior history of any other myopia control treatment (except for single vision distance spectacles) * contraindication for contact lens wear or orthokeratology * preexisting ocular (amblyopia, strabismus, ocular inflammation, trauma, or surgery) or systemic disease * poor compliance to lens wear, examination or follow-up
prevalence of glaucoma in the israeli arab population

Conditions: Glaucoma

Summary: there is a variety of glaucoma prevalence within different populations. this study examine the prevalence of glaucoma in the arab population in israel' as well as the demographic variables and the compliance to treatment in the population.

from medical records of primary care clinic in the city of tira. the patients are recruited, all glaucoma patients are above age of 20 years. they must suffer from cdr \>= 0.5 with/without asymmetry with the other eye. or they suffer from glaucomatous damage to the visual fields.

Eligibility criteria:
inclusion criteria: * cup-to-disk ratio (cdr) \> 0.5 with asymmetry between the eyes * intraocular pressure (iop) \> 23 mm hg * damage to the field of vision * age- above 20 yrs. old exclusion criteria: * none

Keywords: glaucoma, compliance, prevalence
immunogenicity and safety of inactivated and live attenuated hepatitis a vaccines

Conditions: Hepatitis A

Summary: the main purpose of this study was to evaluate the safety and immunogenicity of immunogenicity of inactivated and live attenuated hepatitis a vaccines for healthy chinese people.


Eligibility criteria:
inclusion criteria: * only subjects fulfilling all of the following criteria will be eligible for the study: * people aged from 18 months to 65 years old. * the subjects or subjects' guardians are able to understand and sign the informed consent * the subjects or subjects' guardians allow to comply with the requirements of the protocol * subjects with temperature \<=37.0°c on axillary setting * the subjects have signed informed consent already exclusion criteria: * subjects will not be eligible for the study if any of the following criteria is met: * subject who has a medical history of serious disease including tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc. * have a history of neurological symptoms or signs * have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc. * suffering from serious chronic diseases * suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have hiv infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor * allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk * any prior known or suspected damage or abnormal immune function. as for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months * any prior diseases including human immunodeficiency virus infection or related * bleeding constitution or prolong bleeding time situation * accept hepatitis a vaccination within a month * received vaccines, other immune globulin, any research drug injections in the past 4 weeks * people who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days * caught a fever with axillary temperature 38°c or higher in past 3 days * take part in another clinical researchers * any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent * pregnancy test result is positive

Keywords: safety immunogenicity vaccine hepatitis a
gdnf gene therapy for parkinson's disease

Conditions: Parkinson's Disease

Summary: the objective of this phase 1b investigation is to evaluate the safety and potential clinical effect of aav2-gdnf delivered to the putamen in subjects with either a recent or a long-standing diagnosis of pd.


Eligibility criteria:
key inclusion criteria: * male and female adults 35-75 years of age (inclusive) * diagnosed with parkinson's disease * modified hoehn and yahr stage i-iii off medication * time since receiving a clinical diagnosis of pd and disease severity consistent with one of the following: 1. either: less than 5 years since clinical diagnosis of pd and mild to moderate updrs iii off score 2. or: at least 4 years since clinical diagnosis of pd and moderate to severe updrs iii off score * responsiveness to levodopa key exclusion criteria: * atypical parkinsonism * severe dyskinesia * presence of dementia, psychosis, substance abuse or qualify as "severe depression" * prior brain surgery (i.e. deep brain stimulator or dbs implantation) or other brain imaging abnormalities * receiving an investigational drug * history of cancer or poorly controlled medical conditions that would increase surgical risk * inability to tolerate laying flat in an mri or allergy to gadolinium

Keywords: pd parkinson's disease neurotrophic factor growth factor glial cell line-derived neurotrophic factor gdnf aav gene therapy
yoga for a healthy heart

Conditions: Hypertension

Summary: the yoga for a healthy heart study will address various barriers to both medication management and blood pressure regulation for african american patients with hypertension.

the program will take place in person at south pointe's hospital community outreach center. the program will be an 8-week program, once per week, 60 minutes in length, consisting of meditation, or relaxation, pranayama which are breathing techniques and asana, or physical postures. yoga, is defined as the fluctuations or roaming tendencies of the mind according the patanjali's yoga sutras. in addition to therapeutic yoga techniques, lifestyle management will be discussed or self-reflections written in journals. lifestyle management skills include learning how to take blood pressure and manage a pillbox, as well as develop prosocial communication skills through lessons on mindful communication. the classes will be taught in person. the instructor facilitating the program will be a skilled healthcare professional certified in both occupational therapy and yoga teaching at the 500-hour level. the occupational therapist will provide both skilled assessments and interventions in the group setting of the community health class. assessments include: 1. perceived stress scale 2. canadian occupational performance measurement 3. mini and medi-cog 4. blood pressure assessments pre and post class. .

Eligibility criteria:
inclusion criteria: * over 18 * has transportation to south pointe hospital * has the ability to walk, or use a wheelchair from the entrance of the building * able to attend all 8 sessions * diagnosis of hypertension * african american * prescribed antihypertensive medication * able to stand up from the chair independently * able to walk to the bathroom independently with or without a device * approved by cardiologist to participate exclusion criteria: * unable to tolerate sitting for 1 hour * bp over 200/100 * unable to independently walk or use a wheelchair to the bathroom
arterial stiffness and calcifications in incident renal transplant recipients

Conditions: Renal Transplant; Atherosclerosis; Arterial Stiffness

Summary: the purpose of this study is to determine the: * natural history of calcification posttransplantation * natural history of bmc following renal transplantation * reverse correlation between calcification score and aortic calcifications following renal transplantation * correlation of imt, bmc, pwv and biochemical variables * correlation of imt, bmc, pwv, biochemical variables and outcome * predictors of cv disease after transplantation * predictors of imt progression, bmc loss and pwv progression after renal transplantation


Eligibility criteria:
inclusion criteria: * incident renal transplant patients or combined renal/pancreas transplant patients

Keywords: calcification bone lesions
monthly and twice monthly subcutaneous dosing of pf-04950615 (rn316) in hypercholesterolemic subjects on a statin

Conditions: Hypercholesterolemia

Summary: to evaluate the low density lipoprotein-cholesterol (ldl-c) lowering effect of pf-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose ldl-cholesterol is \>/=80 mg/dl on background treatment with a statin.


Eligibility criteria:
inclusion criteria: * subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial. * lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on day 1: * fasting ldl-c greater than or equal to 80 mg/dl (2.31 mmol/l); * fasting tg less than or equal to 400 mg/dl (4.52 mmol/l). * subject's fasting ldl-cholesterol must greater than or equal to 80 mg/dl (2.31 mmol/l at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial. exclusion criteria: * participation in other studies within 3 months before the current study begins and/or during study participation. * severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product. * history of a cardiovascular or cerebrovascular event or procedure (eg, mi, stroke, tia, angioplasty) during the past 6 months. congestive heart failure (chf), nyha functional classes iii or iv. * poorly controlled type 1 or type 2 diabetes mellitus (defined as hba1c \>9%). * poorly controlled hypertension.

Keywords: pf-04950615 rn316