Kornimate/medical-research-clean huggingface dataset:
an ischaemic stroke observational study

Conditions: Stroke

Summary: a non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke

primary objective: to document and better define the prognostic characteristics of residual disability 12 months or more following an ischaemic stroke in patients that originally participated in the preceding clinical study rn-cs-0001. other objective: to inform the design of efficient phase 2/3 studies when screening potentially efficacious interventions for signals of activity which merit further development.

Eligibility criteria:
inclusion criteria: * capacity to give informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to physical impairments. * participation in the preceding study rn-cs-0001 * completion of at least one of the 4 functional assessment tests (arat, bi, nihss, mrs) at any time point on the previous study rn-cs-0001 * ability to participate in all assessments and attend all visits exclusion criteria: * any additional incidence of stroke (ischaemic or haemorrhagic) since participation in the previous study rn-cs-0001 (since the last cs-0001 assessment visit date). * incidence of significant other disease that judged by the investigator would confound completion of all functional assessments (not excluding patients that can complete at least one functional assessment with no confounding factor from significant other disease).
eoe food test pilot interventional study

Conditions: Eosinophilic Esophagitis Caused by Food (Disorder)

Summary: the objective of this study is to determine the performance characteristics of a series of novel, non-invasive allergen-activated t cell assays designed to identify eosinophilic esophagitis (eoe) causal foods, when used in conjunction with standard-of-care (soc) practices. the question it aims to answer is: will assay results accurately predict eoe food allergies in concordance with soc endoscopies after diet changes?

this proof-of-concept, interventional prospective cohort study will enroll subjects with eosinophilic esophagitis (eoe) who have not yet identified causal foods. subject blood will be drawn and food-activated t cell responses will be assayed. subjects will be advised to remove foods based on standard-of-care practices and/or the outcome of their t cell assays ("personalized elimination diet"). symptoms will be measured by the pediatric eosinophilic esophagitis symptom scores (peess) child and parent surveys and standard of care (soc) endoscopy with esophageal biopsy, respectively. response to research assay-directed diet changes will provide information about the assay's clinical value.

Eligibility criteria:
inclusion criteria: diagnosis of eosinophilic esophagitis (eoe) based on positive esophageal biopsy (\>15 eosinophils/high power field) within three months of enrollment. and intention to undergo dietary intervention for treatment of their eoe. and unknown contribution of one or more of milk, soy, egg, and wheat to their eoe disease state. and willingness to adopt an elimination diet based in part on the results of the experimental testing. exclusion criteria: proton pump inhibitor (ppi)-responsive eoe: resolution or response of eoe to high-dose ppi (2 mg/kg) alone, at the pi's discretion. or presence of other inflammatory or infectious gastrointestinal pathology (e.g. eosinophilic gastrointestinal diseases, irritable bowel disease, infectious colitis, etc.), at the discretion of the principal investigator (pi). or prior medical or surgical history that precludes safely performing an upper endoscopy with biopsy or restriction of diet. or current immunomodulatory therapy \>4 weeks (swallowed or systemic steroids, biologic therapy, chemotherapy. etc.) that may interfere with the blood test or biopsy results, at the pi's discretion. or inability to read or understand english.
remotely observed methadone evaluation ii

Conditions: Opioid Use Disorder

Summary: methadone is an effective treatment for severe opioid use disorder (oud), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (otps). sonara health designed a hipaa-compliant web-application called sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (mbc) framework called the opioid craving visual analogue scale (oc-vas) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. phase ii of this sbir aims to compare sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.


Eligibility criteria:
inclusion criteria: * willing to participate in a randomized trial * able to complete study instruments and interviews exclusion criteria: * less than 18 years of age * pregnant or planning to be pregnant * currently involved in the criminal justice system * serious mental health problems * treated with buprenorphine please note: the enrollment target (2.5 randomizations per week over 50 weeks) includes oversampling women and under-represented racial/ethnicity groups (i.e., at least 10 or more individuals per group who identify as black, hispanic, and american indian/alaskan native).
lateral sinus augmentation using l-prf as sole graft material

Conditions: Maxillary Diseases

Summary: severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. in this study, the abc sinus classification was followed in case selection. a sinus augmentation is done with several techniques. sinus membrane elevation is done with two different approaches, either the crestal approach or lateral window approach. using biofiller material for sinus membrane elevation has been tried by many researchers, using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or with implant tenting. in this study, sinus augmentation was performed using a lateral window approach using l-prf as sole biofiller material in one group, xenograft as only biofiller material in the second group and mixed xenograft with l-prf in the third group. histomorphometric analysis was done from the core biopsy after three months of augmentation, and implant placement was done. after three months, prosthetic parts were placed. the results of this study show that the augmentation of the sinus using l-prf mixed with bone graft is showing the best results followed by l-prf only, and the least was xenograft. from this point of discussion, it can be considered that using l-prf as sole biofiller material in sinus augmentation.


Eligibility criteria:
inclusion criteria: 1. healthy adult patients. 2. both sex, males and females. 3. age from 24 - 49 years old. 4. all patients were free from any systemic diseases as evidenced by burkett's oral medicine health history questionnaire. 5. extraction done at posterior maxilla involved with the maxillary sinus. 6. remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically. 7. gingival biotype 1-2mm thickness. 8. patient has no previous surgery in maxillary antrum. exclusion criteria: 1. smokers. 2. pregnant and breast-feeding females. 3. mentally retarded patients. 4. presence of hematologic disease. 5. previous radiation, chemotherapy, or immunosuppressive treatments. 6. diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy. 7. patient with history of chronic sinus pathosis 8. anticoagulant drugs, endocarditis risk factors, renal and hepatic failure.
guided imagery and patient satisfaction (gimps) following urogynecological surgery

Conditions: Pelvic Organ Prolapse

Summary: we hypothesize that women who use gim pre-operatively will feel more prepared for surgery, have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after surgery compared to women who undergo our routine pre-operative care.

guided imagery (gim) is a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state. in clinical settings, it was originally found effective in treating patients suffering primarily from emotional or psychological issues by using descriptive language and the five senses to help the patient visualize their desired change or outcome (1, 2). more recently, gim has been incorporated into chemotherapy and surgical settings. while it has not been conclusively found to improve outcomes, patients who received gim reported feeling less anxious, less nausea following chemotherapy, slightly shorter surgical recovery times and a higher quality of life (3-8). while these studies suggest exciting prospects for the incorporation of gim into the normal pre-op routine, we believe that they have left out one integral piece of the puzzle. we have previously found that patients who feel "unprepared" for surgery have less post-operative satisfaction (9). we propose that the stress and anxiety of the unknown during a patient's surgical experience can make them feel unprepared for surgery. therefore, the same techniques that have been previously shown to decrease these symptoms in chemotherapy treatment and surgery should help patients feel more prepared, and therefore more satisfied with their surgical experience. this key finding would give sufficient support for the incorporation of gim into the pre-op routine of any surgical patient, and may prove to be a successful vehicle for increasing the overall satisfaction of any hospital's patient population.

Eligibility criteria:
inclusion criteria: * routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment * a planned overnight hospital stay * commitment to listen to a 15 minute audio compact disc daily * proficiency in english. exclusion criteria: * not having routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment * not a planned overnight hospital stay * unable to commitment to listen to a 15 minute audio compact disc daily * not proficiency in english.

Keywords: pelvic organ prolapse surgery
a study to assess variation in potential biomarkers in friedreich ataxia

Conditions: Friedreich Ataxia

Summary: to test the variability of specific ribonucleic acid (rna) and proteins as well as frataxin levels in samples of blood and buccal cells taken directly from patients with friedreich's ataxia (frda) in order to confirm potential new biomarkers of disease in patients with frda.

primary objective: the primary objective of this study is to identify whether frataxin levels and specific rnas and proteins in blood and buccal cells differ between patients with frda and controls. secondary objective: the secondary objectives of this study are: * to understand the variability of frataxin and specific rnas and proteins identified in buccal cells. * to correlate levels of frataxin and specific rnas and proteins with features of frda. * to correlate levels of frataxin and specific rnas and proteins with triglycerides, high density lipoprotein (hdl), low density lipoprotein (ldl) levels, and other lipids.

Eligibility criteria:
inclusion criteria: 1. male and female patients with frda confirmed by genetic testing (frda subjects only). 2. children and adults between the ages of 12 and 65 (inclusive); age for controls will be +/- 2 years relative to frda subjects. 3. subject (and/or parent/legal guardian) has voluntarily signed consent form. 4. willingness and ability to comply with all study procedures. 5. functional disability stage (fds) of 3, 4, or 5 (frda subjects only). exclusion criteria: 1. treatment with an investigational product within 30 days of study. 2. use of gamma interferon or receiving any dose of gamma interferon within 90 days of the specimen collection day. 3. use of any statin medications within 90 days of the specimen collection day. 4. use of any lipid-lowering agents within 6 weeks of the specimen collection day. 5. use of daily biotin supplementation that exceeds 30 mcg/day, either as part of a multivitamin or as a standalone supplement, within 7 days of the study visit. 6. pregnant women.
protective effect of biodegradable collagen implant (ologen) in scleral thinning after strabismus surgery

Conditions: Exotropia or Intermittent Exotropia

Summary: this study is to investigate protective effect of biodegradable collagen implant in scleral showing after lateral rectus recession in patients with exotropia.


Eligibility criteria:
inclusion criteria: 1. patients with intermittent exotropia or constant exotropia 2. alternate prism cover test showed 20 prism diopters or more than 20 prism diopters exotropia 3. subjects who want to do strabismus surgery exclusion criteria: 1. subject who had previous strabismus surgery or other ocular surgery history 2. thyroid eye disease or other connective tissue disease 3. significant bleeding or scleral perforation during operation 4. subjects who need to do medial rectus resection, not lateral rectus recession 5. subjects who had a plan to do other intra or extraocular surgery within 3 months

Keywords: biodegradable collagen implant scleral thinning strabismus surgery
resin modified glass ionomer versus self-adhesive resin composite restorative systems

Conditions: Secondary Caries Dental Restoration Failure of Marginal Integrity

Summary: to evaluate and compare two-year clinical performance of commercially available resin modified glass ionomer cement, self-adhesive composite hybrid and self-adhesive flowable composite restorative materials for non-carious cervical lesions

the experimental design description adhered to the guidelines provided by the consolidated standards of reporting trials (consort) statement. the present study is planned as a double-blinded randomized clinical trial, ensuring that both the patients and the examiner are unaware of the treatment allocation. the trial will follow a parallel design. a total of 35 patients, who are seeking dental treatment, will be enrolled in the study. the participants will be recruited from the operative department clinic at the faculty of dentistry, university of mansoura. the study will focus on 105 class v restorations.a randomized clinical trial will be performed. a number of 35 patients will be included in this study. each patient will have at least three nccls. one of these lesions will be randomly restored with resin modified glass ionomer cement, the second lesion will be restored with self-adhesive surefil one composite hybrid while the third lesion will be restored with self-adhesive flowable composite. no active advertisement will be used for participant recruitment, and instead, a convenience sample will be formed. prior to participating in the study, each patient will be required to provide informed consent by signing a consent form. the study is scheduled to be conducted from may 2023 to may 2025. the form and protocol of the study will be approved by mansoura university's ethics committee before initiation. clinical evaluation for all restorations will be done at baseline (after insertion) and after 6, 12 and 24 months of clinical service by two calibrated independent examiners that will not share in restorations placement. it will be designed depending on modified usphs criteria and fdi criteria

Eligibility criteria:
inclusion criteria: * inclusion criteria will be fair oral hygiene patients with 30-60 years. patients with at least three similarly sized non-carious cervical lesions (nccls) in vital teeth that need for restoration and depth of nccls will be 1-3 mm with at least 50% of margins without enamel. exclusion criteria: * exclusion criteria will be patients with severe periodontitis, mobile teeth, fractures, severe bruxism, carious teeth, poor oral hygiene, teeth with irreversible pulpitis and endodontically treated teeth.
a bioequivalence study using clinical endpoint for diclofenac sodium gel 1% in osteoarthritis knee"

Conditions: Osteoarthritis, Knee

Summary: this randomized, double-blind, three-arm, placebo controlled, bioequivalence study with clinical endpoint has been designed to establish clinical equivalence and safety of mylan's diclofenac gel in the symptomatic treatment of osteoarthritis of knee compared to voltaren® gel and to establish superiority in efficacy of both compared to a placebo (vehicle) gel. male or non-pregnant female aged ≥ 35 years with a clinical diagnosis of osteoarthritis of the knee according to the american college of rheumatology (acr) criteria total study duration for the clinical part will be around 56 days that includes screening period of 28 days and treatment period of 4 weeks.


Eligibility criteria:
inclusion criteria: * osteoarthritis knee as per american college of rheumatology (acr) criteria * evidence of oa with kellgren-lawrence grade 1-3 disease. * after discontinuing all pain medications, had at least moderate pain on movement (pom) for target knee * after discontinuing all pain medications for at least 7 days has a baseline western ontario and mcmaster universities osteoarthritis index (womac likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization. * able to tolerate rescue medication with acetaminophen * subjects who can read and understand womac pain sub scale exclusion criteria: * pregnancy, lactation * oa of kellgren-lawrence grade 4 * oa pain in the contralateral knee requiring medication (otc or prescription) * history of oa of either hip or hands * history of secondary oa (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis * history of chronic inflammatory disease (e.g., colitis) or fibromyalgia * history of drugs or alcohol abuse within the previous year * symptomatic peripheral vascular disease of the study leg * any musculoskeletal condition * skin disease at the application site * active asthma requiring periodic treatment with systemic steroids * known history of positive hiv, hepatitis c virus, or hbsag * uncontrolled hypertension * history of myocardial infarction, thrombotic events, stroke etc. * allergy to aspirin, nonsteroidal anti-inflammatory drugs (nsaid) or acetaminophen (paracetamol).
effect of hypoxic conditioning on cerebrovascular health in the elderly

Conditions: Hypoxia; Cerebral Hypoxia; Brain Diseases; Exercise; Aging; Cognitive Decline; Healthy Aging

Summary: in line with the ever-growing aging of western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. the alteration of vascular function (at the cerebral and systemic level) with aging is an important feature in the clinical picture including a decrease in physical and cognitive capacities. although physical activity is recognized as an essential means of combating the effects of aging, optimizing its effects by defining the most effective strategies of practice remains a key objective. offering alternative interventions to exercise training is also necessary for people who are unwilling or unable to engage in a physical activity program. in this context, hypoxic conditioning, alone or in conjunction with rehabilitative exercise training, is a new therapeutic modality with strong preclinical validity, in particular from a cardiovascular standpoint, and used in other pathologies to improve cardiovascular function and exercise performance and quality of life. our aim is, therefore, to investigate the effect of hypoxic conditioning (alone or in conjunction with exercise training) on cerebrovascular health in the elderly.


Eligibility criteria:
inclusion criteria: * 60 to 80 years of age; * being physically inactive (less than 150 min/week of moderate to intense physical activity); * no chronic cardiovascular, respiratory, metabolic or neuromuscular disease counterindicating an exercise training or hypoxic conditioning program; * health coverage; * being able to provide written fully informed consent. exclusion criteria: * body-mass index \>30 kg/m2; * smoking (\> cigarettes/day); * alcohol use (\> 10g/day); * mental disorder or history of mental disorder; * beta-blockade treatment; * inability or refusal to provide informed consent; * no health coverage * people exceeding the annual ceiling of allowances received as a result of their participation in other clinical trials; * people deprived of freedom by judicial or administrative decision; * people subject to legal protection, who cannot be included in clinical trials.
blood sugar responses by physical activity level and intensity

Conditions: Diabetes

Summary: this observational study is designed to examine the glycaemic responses (of sedentary, active and very active healthy individuals) to a 50gram dose of glucose.

3 groups of participants fulfilling the criteria for: sedentary (\ 30 mins phys act p/day) and very active (\> 60 mins phys act p.day) will be invited to attend a laboratory session on two separate occasions separated by one week and asked to: fast overnight before having a baseline and then six further capillary (finger-prick) blood samples taken over a period of two hours following consumption of 50 grams of glucose. the blood samples will produce a standard glucose 'curve' and this will be used to calculate incremental area under the curve to identify similarities or differences between the three groups responses. hypothetically it may be that the different levels and intensities of physical activity will affect the results with active individuals producing flatter better-controlled blood sugar responses than the inactive subjects. the null-hypothesis would be no difference in response. it is possible, for instance, that such a low-dose of glucose in an otherwise healthy group of individuals has no discernible affect on such a curve. physical activity will be assessed by questionnaire and interview. anthropometric measures (height, weight and body composition) will be taken using a stadiometer and bio-electrical impedance unit (bodystat 1500, body stat: isle of man uk) at the time of the laboratory measures. no participants will have data taken of any kind before they have read a participant information sheet and signed informed consent.

Eligibility criteria:
inclusion criteria: * male and female. * age:19-59 * inactive, active or very active according to criteria outlined. exclusion criteria: * diabetics other chronic condition likely to affect blood sugar * \ 59 age