Kornimate/medical-research-clean huggingface dataset:
impact of virtual reality hypnosis on pain and anxiety during dressings change in burn patients

Conditions: Burns; Pain, Acute; Anxiety

Summary: different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of pain related to burn injury. a new technique called 'virtual reality hypnosis' (vrh) (patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. with the goal to improve our understanding of vrh combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception. 100 patients who are treated as outpatients for burn care will be randomly assigned to virtual reality or vrh. patients will receive one session of one of these techniques during burn dressing change.physiological parameters will be recorded during dressing change. participants will fill in a questionnaire evaluating their tendency to be absorbed and dissociated, and another evaluating their level of perceived immersion. their level of anxiety, pain, fatigue and relaxation will be evaluated before and after the session. a short interview will also be conducted to give participants the opportunity to openly describe their experience.


Eligibility criteria:
inclusion criteria: * burn patient treated as outpatient * burn surface area \> or = 5% of the total body surface area * mainly 2nd degree burn exclusion criteria: * psychiatric antecedents * claustrophobia * heavy hearing * visual impairment * face burn * conjunctivitis * consent not obtained
in vitro activity of ceftolozane/tazobactam and imipenem/relebactam in clinical isolates of pseudomonas aeruginosa and enterobacterales collected from hematology and oncology patients

Conditions: Ceftolozane/Tazobactam; Imipenem/Relebactam; Hematology and Oncology

Summary: the purpose of the actheon study is to evaluate the in vitro activity of ceftolozane-tazobactam, imipenem-relebactam and comparator agents (amoxicillin- clavulanate, piperacillin-tazobactam, ceftazidime, cefotaxime, cefepime, imipenem, meropenem, levofloxacin and amikacin; see list more details on page 7) against clinical isolates of p. aeruginosa and enterobacterales prospectively collected from hematology and oncology patients with complicated intra-abdominal infections (ciais), complicated urinary infections (cutis), lower respiratory tract infections (lrtis), and blood stream infections (bsis) from 15 participating centers in spain


Eligibility criteria:
inclusion criteria: * p. aeruginosa isolates * enterobacterales isolates exclusion criteria: * non p. aeruginosa isolates * non enterobacterales isolates
the treatment of posterior semicircular canal benign paroxysmal positional vertigo

Conditions: Benign Paroxysmal Positional Vertigo

Summary: the purpose of this study was to compare the treatment effectiveness of three different methods for posterior semicircular canal benign paroxysmal positional vertigo. the included methods are modified epley maneuver, semont maneuver and sham maneuver.

this study was a prospective, double blinded, randomized, multicenter clinical trial. the enrolled posterior semicircular canal benign paroxysmal positional vertigo patients were randomized to one of the three treatment regimens when they are diagnosed with the dix-hallpike test. an then the patient was treated with one of the three maneuvers. after 20 minutes, the patient was examined with the dix-hallpike test again. the resolution of nystagmus and symptoms were checked. when the nystagmus was sustained, the same treatment was applied once again. and after 20 minutes, the patient was examined with the dix-hallpike test too. 1 day after and 7 days after, the patient was re-examined with the dix-hallpike test.

Eligibility criteria:
inclusion criteria: * a symptom of positional vertigo * rotational and upbeating nystagmus in dix-hallpike test * the nystagmus should be disappear within 60 seconds * no spontaneous nystagmus exclusion criteria: * ages under 18 years * suspicious or verified a central nervous system lesion * traumatic vertigo patients * other otologic disease(acute/chronic otitis media, otosclerosis, etc) * other vestibular disease(vestibular neuronitis, meniere's disease, etc) * congenital nystagmus patients * the patients with spinal disease * the patients with the limitation of cervical movement

Keywords: pscc(posterior semicircular canal) bppv(bening paroxysmal positional vertigo) vertigo otorhinolaryngologic diseases
heat stress in wheelchair sports

Conditions: Heat Stress; Body Temperature Changes

Summary: the aim of the study is to study the thermoregulatory responses under real life conditions, such as during wheelchair rugby and basketball matches. a further goal is to develop and validate a standardised field-based protocol, which induces the same thermoregulatory response as during a wheelchair rugby and basketball match. this knowledge allows to investigate strategies to reduce heat stress and to enhance exercise performance (e.g. pre-cooling) in the future, based on standardised conditions.

a spinal cord injury leads to several physiological changes and complications, which might influence exercise performance (perret and abel, 2016). one major problem is the limited thermoregulation, especially in subjects suffering from a tetraplegia (griggs et al., 2015; price et al., 2006). there are only few studies, which investigated the thermoregulatory response during real life conditions in wheelchair athletes such as during a wheelchair rugby match (griggs et al., 2017). however, to implement strategies to reduce heat stress (e.g. precooling methods) or to determine the influence of heat stress on exercise performance and to determine the effects of specific interventions the following two issues seem to be a prerequisite: first of all, we need to understand, which thermoregulatory response is induced under real life conditions, e.g. by a wheelchair rugby or basketball match. second, if we want to study the effects of potential interventions, a standardised and reliable study protocol has to be available, which closely mimics match conditions and induces a similar amount of heat stress. thus, the aim of the study is to measure thermoregulatory and physical performance outcomes during a real life wheelchair rugby and basketball match. a further goal is to develop and validate a standardised field-based protocol, which induces a similar thermoregulatory response as during a wheelchair rugby or basketball match. these knowledge builds the basis for future thermoregulatory studies based on a reliable and standardised field-based testing protocol.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * healthy, male or female wheelchair rugby (with tetraplegia) or basketball player (with paraplegia) of national or international level * regularly taking part in competitions/games * age between 18 and 60 years exclusion criteria: * asthma * blood disorders * actual injury, which impairs performance or other impossibility to exercise to exhaustion * cardiovascular disease * gastrointestinal disease, disorder or former surgery concerning the gastrointestinal tract * not able to swallow a capsule * less than 40kg of body mass * mri during the period of use of the e-celsius® device
myotonic dystrophy and facioscapulohumeral muscular dystrophy registry

Conditions: Myotonic Dystrophy; Facioscapulohumeral Muscular Dystrophy; Muscular Dystrophy; Myotonic Dystrophy Type 1; Myotonic Dystrophy Type 2; Congenital Myotonic Dystrophy; PROMM (Proximal Myotonic Myopathy); Steinert's Disease; Myotonic Muscular Dystrophy

Summary: myotonic dystrophy (dm) and facioscapulohumeral muscular dystrophy (fshd) are inherited disorders characterized by progressive muscle weakness and loss of muscle tissue. the purpose of this registry is to connect people with dm or fshd with researchers studying these diseases. the registry will offer individuals with dm and fshd an opportunity to participate in research that focuses of their diseases. the registry will also help scientists to accomplish research on dm and fshd and to distribute their findings to patients and care providers.

the national registry of dm and fshd patients and family members was developed to create a link between patients and scientists in order to promote research on these rare illnesses. the registry is sponsored by the national institutes of health. patients that are interested in joining the registry can email or call to request an application or download the forms from the website (www.dystrophyregistry.org). the application packet contains: * a patient information form, which asks about your muscle strength, general health, and how your disease affects your daily life * a medical records release form, which allows us to contact your doctor and obtain records about your diagnosis * an informed consent form, which describes the study's purpose and what you can expect while you are involved with the project. after you are enrolled in the registry, there are several ways to participate in research. the activities include: * complete an annual update form to help us keep track of how your symptoms change over time. * receive updates about the progress of the registry, research highlights, and other news related to muscular dystrophy through newsletters, an email listserv, and facebook. * receive letters from the registry when researchers are looking for patients to take part in studies. these projects may include filling out questionnaires, exploring new treatments, and other types of research. there is no obligation to participate in these activities. taking part in any study or filling out the annual updates are completely up to you.

Eligibility criteria:
inclusion criteria: * diagnosed with dm, fshd, or related diseases or are an unaffected family member of someone diagnosed with one of these diseases

Keywords: registry fshd dm muscular dystrophy facioscapulohumeral myotonic dystrophy myotonic dystrophy dm1 dm2 fsh mmd
clinical research on the treatments on advanced malignant melanoma by combining in situ immunotherapy and laser therapy

Conditions: Melanoma

Summary: to evaluate the therapeutic efficacy and the safety for the treatments on malignant melanoma by combining semiantigen dinitrophenyl (dnp) in situ immunotherapy and laser therapy, and carry out monitoring on related immunological parameters of the patients. 72 patients with stage iii (b or c) or stage iv skin (which could not be excised by operations) malignant melanoma were treated by combining simple semiantigen dnp in situ immunotherapy and laser therapy respectively. the changes in peripheral blood cd4+cd25+treg regulatory t cells (treg), cd8+t, cd4+ t effector cells, il-10, tgf-β and other inhibitory cytokines of the patients were detected, the changes in anti-dnp igg antibody titer was monitored, the relationship between delayed-type hypersensitivity (dth) and survival was observed, and results of clinical follow-ups were also examined.


Eligibility criteria:
inclusion criteria: * pathologically diagnosed as malignant melanoma, hmb45 (+～++++), s100 (+～++++); * basically normal hepatic and renal functions as well as results for blood routine examinations; * karnofsky score ≥ 60; * anticipated life span for more than three months; * they were all malignant melanoma patients suffering from skin malignant melanoma of local or distal metastasis unsuitable for operations in their skin; * the therapeutic efficacy was objectively evaluated with reference to the criteria from who; * all of the subjects had signed the informed consent and had been submitted and approved by the ethic committee of the hospital, the compliance was good and follow-ups can be easily carried out.
probiotic and prebiotic supplementation in elite athletes with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the main objective of this pilot study is to obtain information, which will be used for the design of a main randomized controlled trial (rct) with a larger size based on feasibility, validity and sample size estimation as well as the potential effects of pre- and probiotic intake on intestinal microbiota. a larger trial will then be designed to test the hypothesis that adding probiotics or prebiotics may improve gut microbiome composition, gastrointestinal symptoms as well as cardiometabolic health indices in mid-term and possibly lead to improved sports performance over a longer-term period in athletes with a spinal cord injury.

in this pilot crossover randomized controlled trial, twenty (n = 20) para-athletes will participate in an intervention consisting of a four-week intake of probiotic, using the commercially available multistrain probiotic preparation "bactosan pro fos" from mepha (basel, switzerland), followed by a four-week wash-out period, and a four-week prebiotic intervention using "naturaplan bio oat bran" (coop, switzerland). total duration of the study will be 16 weeks.

Eligibility criteria:
inclusion criteria: * athletes with a spinal cord injury shortlisted as potential participants for major international events, such as the paralympic games 2021 in tokyo and world championship qualification exclusion criteria: * chronic inflammatory bowel diseases (i.e. ulcerative colitis, crohn's disease) * taking antibiotics and/or other medication to alleviate gastrointestinal complaints at recruitment time point * pregnancy

Keywords: probiotic supplementation prebiotic supplementation
hunger and learning study in preschoolers

Conditions: Hunger; Ingestive Behavior; Obesity; Food Preferences

Summary: this prospective random controlled cross-over intervention studies is designed to ascertain if children feel different levels of hunger and fullness before and after eating test meals consisting of high-satiety vs. usual foods and if the child's perceived hunger/fullness is related to their salivary ghrelin levels and a variety of learning outcomes. data are collected at the diet and nutrition (dan) laboratory on repeated study days (8am - 4 pm).

the investigator's previous research has shown that preschoolers recognized changes in the feelings of hunger/fullness before and after a single test meal. if preschooler's feelings of hunger are associated with their ghrelin (hunger hormone) levels is not known. this study is designed to assess children's changes in feelings of hunger throughout the day (8 pm to 4 pm) and to measure both subjective feelings of hunger and salivary ghrelin levels before and after a standardized test meal (lunch). an important secondary outcome related to children's feelings of hunger is their ability to learn. currently, there is lack of data on the direct link between perceived hunger/fullness and learning processes. this study addresses these gaps using preschooler's perceived feelings of hunger and fullness (using a published 4-point scale (kranz s.et al. "high-protein and high-dietary-fiber breakfasts result in equal feelings of fullness and better diet quality in low-income preschoolers compared with their usual breakfast" j nutr doi: 10.3945/jn.116.234153, 2017) and a battery of learning tests (htks, krisp, stroop-style tasks, woodcock johnson vocabulary test, dccs, and curisoty measures.)

Eligibility criteria:
inclusion criteria: * healthy children exclusion criteria: * no food allergies * no medications that affect behavior/learning/appetite
biological effect of warfarin on pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study aims to asses the effect of warfarin on markers of axl pathway in patients with pancreatic adenocarcinoma.

there is emerging evidence from pre-clinical models that axl activation is critical for the tumorigenesis and metastasis of pancreatic cancer. warfarin is a readily available drug in the clinical setting and could be easily, safely, and quickly used in patients in combination with known cytotoxic chemotherapies to improve overall survival. oral warfarin has been well tolerated in both prophylaxis for catheter-associated thrombosis and in advanced pancreatic cancer patients. the aim of this trial is to confirm the preclinical evidence that warfarin affects axl pathway in patients with pancreatic cancer. this will validate the effect of escalating doses of warfarin on circulating biomarkers of axl.

Eligibility criteria:
inclusion criteria: * pathologically-confirmed, localized or metastatic adenocarcinoma of the pancreas. diagnostic biopsy must be obtained at the study institution prior to enrollment. pathology material must be available for review. * patient must have measurable disease per recist criteria * started most recent systemic therapy regimen within 15 days of enrollment (any line of therapy is allowed). * ability to tolerate, swallow and absorb oral medications. * ability to understand and the willingness to sign a written informed consent. * age \> 18 years * negative blood pregnancy test within seven days of study entry for wocbp * a female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). exclusion criteria: * active radiation therapy, or planned radiation therapy during study period * subjects may not be receiving any other investigational agents. * pregnant, nursing or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be potentially teratogenic. * underlying condition which may increase the risk of complications from warfarin therapy. these can include: known major bleeding diathesis: * coagulopathy * significant gi bleed within 6 months, * clinically significant hematuria or hemoptysis, * thrombolytic therapy within one month of study entry, * active peptic ulcer disease with bleeding. - significant infection or other coexistent medical condition that would preclude protocol therapy including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
mechanistic study of isis isis-apociiirx in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the effects of isis isis-apociiirx on triglyceride levels and insulin sensitivity in subjects with type 2 diabetes on stable treatment with metformin.


Eligibility criteria:
inclusion criteria: * bmi \>/= 25 to \</= 40 kg/m2 * type 2 diabetes mellitus and on a stable dose of metformin * hypertriglyceridemia exclusion criteria: * significant abnormalities in medical history, clinical examination or clinical testing * use of oral anti-diabetic medication other than metformin within 3 months prior to dosing * history of outpatient insulin use for more than 2 weeks in the last year
endoscopic surgery for gastrointestinal disorders: a multicenter registry study

Conditions: Achalasia; Gastric Outlet Obstruction; Gastroparesis; GERD; Reflux; Fistula; Benign Neoplasm

Summary: currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at rutgers rwjms. the purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of endoscopic surgery within the gastrointestinal tract.

our tertiary-care institution performs clinically-indicated various endoscopic surgery procedures gastrointestinal indications in more than 800-1000 patients annually. the study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as poem (peroral endoscopic myotomy), emr (endoscopic mucosal resection), esd (endoscopic submucosal dissection), ster (submucosal tunneling endoscopic resection), notes (natural orifice translumenal endoscopic surgery), tif (transoral incisionless fundoplication), endoscopic fistula closure, endoscopic suturing, capsule endoscopy and eftr (endoscopic full-thickness resection). clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time. various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention. they improve quality of life and extend survival duration. endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall. currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at rutgers rwjms. the purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of endoscopic surgery within the gastrointestinal tract.

Eligibility criteria:
inclusion criteria: * subjects undergoing endoscopic surgery exclusion criteria: * subjects not undergoing endoscopic surgery

Keywords: poem esd ster eftr emr notes tif capsule endoscopy endoscopic suturing endoscopic fistula closure zpoem gpoem
clinical study of ivonescimab for first-line treatment of metastatic nsclc patients

Conditions: Non-Small Cell Lung Cancer

Summary: this is a phase 3 randomized, double-blind, multiregional study of ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy for the first-line treatment of metastatic non-small cell lung cancer. the primary endpoint is overall survival and progression free survival assessed by investigator. the key secondary endpoints include response and safety.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old at the time of enrollment * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * expected life expectancy ≥ 3 months * metastatic (stage iv) nsclc * histologically or cytologically confirmed squamous or non-squamous nsclc * recorded measurement of the tumor proportion score (tps) for pd-l1 expression, irrespective of the pd-l1 expression, prior to randomization * at least one measurable noncerebral lesion according to recist 1.1 * no prior systemic treatment for metastatic nsclc exclusion criteria: * histologic or cytopathologic evidence of the presence of small cell lung carcinoma * known actionable genomic alterations (egfr, alk, ros1, and braf v600e) or genes for which first-line approved therapies are available. * for non-squamous histology patients, actionable driver mutation testing results are required before randomization. * has received any prior therapy for nsclc in the metastatic setting * tumor invasion, encasement of organs (e.g. heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.