Kornimate/medical-research-clean huggingface dataset:
endorotor den (direct endoscopic necrosectomy)trial

Conditions: Acute Pancreatic Necrosis; Acute Pancreatitis; Necrotizing Pancreatitis

Summary: a prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the interscope endorotor® resection system in subjects requiring direct endoscopic necrosectomy (den) with walled off pancreatic necrosis (wopn).

a prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the interscope endorotor® resection system in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (wopn). total enrollment 30 subjects with at least 15 enrolled in the us. subjects will be debrided with the endorotor either at the time of stent placement or post placement at investigator's discretion with a maximum of 4 endorotor procedures. a minimum of 2 days is required between each endorotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. follow up is completed 21 (+/- 7) days after last endorotor debridement procedure.

Eligibility criteria:
inclusion criteria: 1. subjects who are \>22; inclusive of males and females. 2. patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone eus-guided drainage 3. imaging suggestive of greater than or equal to 30% necrotic material 4. walled off pancreatic necrosis size ≥6 cm and ≤22cm 5. subject can tolerate repeated endoscopic procedures 6. subject capable of giving informed consent. 7. subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated. exclusion criteria: 1. subject unable to give informed consent. 2. subject is unwilling to return for repeated endoscopies. 3. documented pseudoaneurysm \> 1cm within the wopn 4. intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound). 5. dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 6. any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance). 7. pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the investigator, and/or are not willing to use reliable contraception for the duration of study participation. 8. patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

Keywords: direct endoscopic necrosectomy walled off necrosis walled off pancreatic necrosis
azelaic acid foam 15% in the treatment of papulopustular rosacea

Conditions: Rosacea, Papulopustular

Summary: this research study is being performed to evaluate the photographic evidence of the efficacy and tolerability of azelaic acid foam 15% in the treatment of papulopustular rosacea.

this is a single site, single arm open label study of azelaic acid foam 15% for the treatment of moderate to severe papulopustular rosacea. all patients will apply azelaic acid foam twice daily. at scheduled visits, high resolution equipment will be used to measure 3d topographical values for elevation of papules and pustules to objectively evaluate reduction of papulopustular lesions. investigator and subject assessments will also be completed to assess the level of rosacea at weeks 4,8 and 12.

Eligibility criteria:
inclusion criteria: 1. male or female subjects age 18 or older. 2. diagnosis of moderate to severe papulopustular rosacea with iga of 3- moderate or 4-severe. 3. presence of 12 - 50 inflammatory lesions and persistent erythema with or without telangiectasia. 4. subjects must read, understand, and sign the informed consent. 5. subjects must be willing and able to comply with study procedures and visit schedule requirements. 6. women of childbearing potential that are willing to use an acceptable method of contraception during the study. exclusion criteria: 1. active or localized or systemic infections. 2. subjects must not be immunocompromised. 3. known unresponsiveness or allergy to azelaic acid. 4. subjects unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g. drug or alcohol abuse). 5. subjects must not be pregnant or breastfeeding. 6. presence of dermatoses that might interfere with the ability to diagnose and/or evaluate rosacea. 7. presence of other types of rosacea. 8. laser surgery on the face for the treatment of telangiectasia or other conditions within 6 weeks of study enrollment. 9. use of medications or products for the treatment of rosacea or other medical conditions within the following time periods prior to study enrollment. use of these medications will be prohibited during the trial. topical prescription or nonprescription medications 6 weeks oral retinoids 6 months tetracycline (ex. doxycycline, minocycline 2 months corticosteroids 4 weeks erythromycin or azithromycin 4 weeks other systemic medications to treat rosacea 6 weeks 10. refusal to sign the informed consent document or photo release document and/or refusal to comply with all follow-up requirements. 11. use of medications that are known to cause flushing. 12. dose changes in the last 90 days or initiation of beta-blockers, vasodilators, vasoconstrictors, nonsteroidal anti-inflammatory drugs, hormone therapy, and/or other drugs known to cause acneform eruptions. -

Keywords: rosacea
the effect of transcatheter vsd closure on children's appetite, hormones and growth

Conditions: Ventricular Septal Defect; Appetite Loss; Growth Delay

Summary: in this study; changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.

the study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. the symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure. anthropometric measurements; weight for age (wfa), height for age (hfa), body mass index (bmi) and their z scores, triceps skinfold thickness (tsf) and mid-upper arm circumference (muac) were recorded on admission. patients with weight for height z score less than -2 were defined as malnutrition. questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. these questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits. during the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. on the same day, igfbp-3, ghrelin and leptin,fasting blood glucose, insulin, igf-1, igfbp-3, aspartate aminotransferase (ast) and alanine aminotransferase (alt), total protein, and albumin were measured. anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.

Eligibility criteria:
inclusion criteria: pediatric patients who underwent transcatheter vsd closure exclusion criteria: * chromosomal abnormalities * additional systemic disease * systemic infections

Keywords: ventricular septal defect appetite growth interventional therapy
effectiveness of mechanical decompression for low back pain relief

Conditions: Low Back Pain

Summary: objective to demonstrate the effectiveness of a conservative treatment approach for chronic low back pain that addresses the underlying problem of intervertebral disc lesions and degenerative disc disease, namely vertebral pressure on vital structures of the lumbar region.

low back pain (lbp) is a common medical problem and a challenging condition to treat. this study will investigate the effectiveness of a conservative treatment approach for chronic lbp. to this point few treatment approaches specifically address the resolution of underlying pathologies leading to a high probability of recurrence of lbp. further, current treatment options for lumbar disc pathology have been of limited demonstrated effectiveness. the purpose of this study is to determine whether a non-surgical therapeutic approach designed to effect intervertebral widening and allow for reduction of disc protrusion will reduce patients' pain and improve their activity levels. the study will assess whether a computer-assisted traction treatment \[decompression\] protocol results in improvement in patient pain levels and daily activity levels. further, to determine if such treatment results in intervertebral widening and reduction of any disc protrusions as demonstrated by direct imaging of the lumbar spine. a double-blind (treatment vs. sham treatment) design will be employed specific aims to study the effectiveness of decompression therapy for lbp patients with lumbar disc herniation and degenerative disc problems. to demonstrate that decompression therapy for lbp patients results in a demonstrated reduction in levels of reported pain. to demonstrate that decompression therapy for lbp patients results in a demonstrated greater return to daily activities. to demonstrate that decompression therapy for lbp patients results in increased intervertebral space and reduced disk protrusion (if present) as measured by mri.

Eligibility criteria:
inclusion criteria: * non-specific lbp of at least 6 weeks duration with no evidence of underlying disease or anatomic abnormalities, * applicants may have pain radiating to their legs. exclusion criteria: * any episode of acute lbp within the last 6 weeks or less * recent fractures, less than 8 weeks of any bone * tumors of any type including soft tissue tumors, myeloma, malignant or documented tumors of any type * gross osteoporosis, * spondylolisthesis grade 2 and above, * hardware fixation, spine fixation or other boney fusion * obesity as defined by a bmi greater than 35, body weight over 287 pounds, * contra-indication for mrj assessment, * pregnancy, * neurologic deficits, * bowel or bladder incontinence, * progressive lower extremity weakness, * need for narcotic pain medications for other conditions.

Keywords: low back pain
spotcheck: comparison of enhanced telemedicine versus in-person evaluation for the diagnosis of skin cancer

Conditions: Skin Cancer

Summary: the overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. this is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. if successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. with decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality.

this is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment of participant-selected skin lesions concerning for skin cancer, controlled against an in-person dermatologist assessment (gold standard evaluation). the study will be a single arm design with each participant undergoing telemedicine data acquisition (i.e. clinical and dermoscopic imaging and nevisense measurement), immediately followed by the in-person dermatologist assessment. the in-person dermatologist will be blinded to the nevisense score at the time of the visit. using the telemedicine data, the teledermatology team will render a biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. they will be blinded to the results of the in-person dermatologist's diagnostic evaluation.

Eligibility criteria:
inclusion criteria: * be 18 years of age or older * have 1-3 lesions for evaluation exclusion criteria: * lesions of the hair-bearing scalp, in the mouth, on the lips, genitalia, nails, on/around the eyes, inside the ear
does addition of a functional knee brace improve rehabilitation outcome in subjects with osteoarthritis of the knee?

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to investigate the effect of functional knee brace in the subjects with medial compartment knee oa.

20 subjects with symptomatic medial compartment knee oa, with grade 2 to 4 on kellgren and lawrence scale, and showing willing to wear a functional knee brace will be recruited into this study. another 20 subjects with comparable body height, weight, and sex will be served as a control group. all of the subjects received 4 weeks' rehabilitation treatment (3 times a week). vas pain score, womac index, and sf-36 will be evaluated before the treatment, and 1 month, and 3 months after the start of treatment. patients' satisfaction will be evaluated at 1 month, and 3 months after start of treatment. patients' compliance and any adverse events due to wearing of the functional knee brace will also be reported. a 2-by-3, 2-way mixed-model analysis of variance, which had 1 between-subject factor (group: knee brace + pt and pt only) and 1 within subject factor (evaluation time:t0, t1, t2) , was performed. pair-wise comparisons between groups were performed using an independent t test (if in normal distribution) or mann-whitney u test (if not in normal distribution). investigators hypothesize that addition of a functional knee brace would improve rehabilitation outcome in subjects with knee oa.

Eligibility criteria:
inclusion criteria: according to the american college of rheumatology (american college of rheumatology) diagnosis of unilateral medial knee osteoarthritis, according to kellgren and lawrence x-rays are classified as two to four acceptable month rehabilitation therapy, and for the first time dressed thruster legacy's functional knee brace. the control group of patients with knee osteoarthritis same conditions, but dressed thruster legacy functional knee brace. exclusion criteria: 1. have undergone knee surgery 2. the lateral tibiofemoral joint severe (tibio-femoral joint) disease 3. serious knee ligament laxity 4. knee flexion contracture (flexion contracture) than 20 degrees 5. unable to walk 6. the skin of metal (aluminum) allergy 7. lower extremity vascular lesions or swelling

Keywords: knee, osteoarthritis, brace
the psvt place registry.paroxysmal supraventricular tachycardia (psvt) registry.

Conditions: Paroxysmal Supraventricular Tachycardia (PSVT)

Summary: paroxysmal supraventricular tachycardia (psvt) is a sporadic, sudden, and recurring tachycardia that is caused by an altered electrical conductivity in the heart. it causes palpitations and a rapid heart rate, which may induce fear in the patient and negatively impact the patient's quality of life. therefore, most patients experience not only physical symptoms of psvt, but also dramatic psychological burdens. as psvt drug development efforts advance, it has become increasingly important to document the impact of psvt in a systematic way, in terms of the disease natural history and clinical characteristics of psvt episodes, as well as the psychological impact of the condition as reported by patients over time. in order to meet the needs for ongoing, systematic data collection on psvt, a multinational registry, the psvt place registry (www.psvtplaceregistry.com), is being implemented and will be initially comprised of data entered directly by patients. the long-term registry is designed with a participant-focused approach to enable continuity of data collection and minimization of impact from changes of participants' health care providers. the registry may be expanded at a later time to include physician-reported data. the information from the registry is planned to be a resource for participants with psvt, their families and support networks, their doctors, and the research community to better understand psvt-related symptoms and awareness, psvt diagnoses, patient self-management, medical treatments for psvt, and impact of psvt on quality of life from the patient perspective.


Eligibility criteria:
inclusion criteria: a participant must meet all of the following criteria to be eligible for participation in the study: * adult male or female. * participant has suspected psvt as per the online prescreening assessment. * participant lives in a country in which the registry is being conducted. * participant has signed the informed consent form indicating he/she is able to complete the online registry data collection forms on his/her own. exclusion criteria: * participant does not have an email address. * participant does not set up a user account.

Keywords: tachycardia psvt episodes
the weight of victory: exploring short- and long-term health outcomes in former male & female elite athletes from weight-sensitive sports

Conditions: Musculoskeletal Health; Fertility; Mental Health; Quality of Life; Body Image; Disordered Eating

Summary: the health of former elite athletes has been identified as a critical research gap where there is limited knowledge about both short- and long-term consequences after ending their careers. the transition phase from an active elite career to everyday life has been shown to be particularly problematic, yet this issue has been little studied among former norwegian elite athletes. furthermore, questions remain regarding the health of athletes from weight-sensitive sports, such as weight-class, aesthetic, and certain endurance sports. these athletes face specific challenges related to maintaining a certain physique and frequent changes in body weight during their active careers. this group has been shown to be vulnerable to a range of problematic health outcomes related to low energy availability, and little is known about the long-term effects of a career involving this. therefore, the overall purpose of the project is to map the mental and physical health of former elite athletes. at the same time, there will be a particular focus on the differences between weight-sensitive and less weight-sensitive sports, different types of sports, gender, as well as previous dieting and eating behaviors.

the project will be a quantitative cross-sectional study that includes former elite athletes from both weight-sensitive and less weight-sensitive sports, as well as a sample from the general population for comparison. information will be collected via an electronic questionnaire that surveys a range of physical and mental health variables among the participants. in addition, behavioral variables related to impulse control, eating and dieting patterns, and weight regulation will be assessed. furthermore, the project is expected to contribute new knowledge by identifying health challenges and the explanatory variables for these challenges among former elite athletes. thus, the project can inform the development of targeted preventive measures, interventions, and policy changes that can improve health and quality of life both during and after athletes' careers and be of significant importance for future athletes.

Eligibility criteria:
inclusion criteria: * represented the national team at senior and/or junior level, (non-organized sports) competed at national and/or international level. , \>1 year since retirement , \>18 years old,and a proficient level of norwegian reading and writing skills exclusion criteria: -

Keywords: elite athletes mental health somatic health disordered eating musculoskeletal health quality of life anxiety and depression behavioral reproductive health fertility harassment body acceptance personality traits weight regulation
evaluation of ifnγ and inflammatory mediators in patients with hemophagocytic lymphohistiocytosis

Conditions: Hemophagocytic Lymphohistiocytoses

Summary: this observational study is designed to provide a better understanding of the potential use of interferon gamma (ifnγ) and ifnγ-inducible chemokines as markers of hlh disease activity in adults, and the potential of ifnγ to represent a therapeutic target.

this is a observational study designed to determine the levels of pro-inflammatory markers in adult patients diagnosed with hlh and to assess the relationship between the biomarkers and disease activity in these patients during the hlh course. inflammatory markers include ifnγ and ifnγ-induced chemokines c-x-c chemokine ligand 9 and c-x-c chemokine ligand 10. in addition to the blood samples for the biomarker analysis, relevant information gathered by the treating physician will be collected in a data collection form. whenever possible, collection of serum samples for biomarker analysis and relevant information should occur at hlh diagnosis, at regular time intervals during the treatment course (not more than once a week) up to resolution of hlh. blood samples will also be sent to the study sponsor (novimmune s.a.) for cytokine testing. before patient's samples are sent to the sponsor for testing, patient's name and any personal identifying information will be coded to protect participant's privacy.

Eligibility criteria:
inclusion criteria: * patients \>=18 years old diagnosed with active hlh as established by the treating physician. * hlh forms of unknown origin or secondary to infections or rheumatologic disorders. * should the diagnosis of primary hlh or malignancy become apparent after inclusion, the data collected will be analyzed separately as additional cohorts. * the patient must have consented to the use of their clinical data for research purposes at the site. exclusion criteria: * patients with primary hlh (diagnosed by the presence of homozygous mutations in a known hlh causative gene) and secondary hlh due to malignancy are excluded.

Keywords: hemophagocytic lymphohistiocytosis interferon gamma ifnγ biomarkers inflammatory markers