Kornimate/medical-research-clean huggingface dataset:
colorectal cancer screening in familiar-risk population: immunochemical fecal occult blood testing versus colonoscopy

Conditions: Colorectal Cancer

Summary: this study is aimed: 1) to compare the accuracy of colonoscopy vs immunochemical faecal occult blood test (ifobt) and colonoscopy when positive for colorectal cancer (crc) screening in familiar-risk population and; 2) to determine the complications associated with both strategies.

this is an observational, controlled, randomized phase iii study to evaluate the effectiveness of the ifobt for detecting advanced neoplasia (polyps \> 1cm in size, high grade dysplasia or with villous component, or crc) in first degree relatives of patients with crc. index cases will be interviewed to obtain the family tree and their first-degree relatives will be contacted to invite them to participate in the study. index-cases, will be randomized into one of the following two groups in order that their relatives receive the same screening strategy: a) colonoscopy; or b) annual ifobt test (oc-sensor®, cut off ≥50 ng/ml) and colonoscopy if positive. to determine the sensitivity and specificity of the ifobt strategy, individuals randomized to group b will be invited to undergo a complete colonoscopy following two years follow-up. in addition, epidemiological data, personal history of disease, family history of neoplasm, characteristics of lesions at colonoscopy and histological diagnosis will be recorded. to test the hypothesis of equivalence between the ifobt test and colonoscopy for detecting advanced colorectal neoplasm, it was considered a probability of participation, detection capability and prevalence of advanced adenomas for ifobt of 0.750, 0.565 and 0.077, respectively, being the product of them 0.033. in the case of colonoscopy, the likelihood of participation, detection capability and prevalence of advanced adenomas in this population at risk are 0,500, 0.965 and 0.077, respectively, and their product 0.037. accordingly, for a type i error (alpha) of 5%, a power of 80% and a maximum deviation between the probabilities of the two tests of 0.03 the number of subjects to be included per arm is 744

Eligibility criteria:
inclusion criteria: * men and women aged 40-75 years, first degree relatives of patients with non-syndromic crc exclusion criteria: * personal history of crc, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease

Keywords: fobt colonoscopy familiar risk colorectal cancer advanced adenoma
impact: implementation of physical activity for children and adolescents on treatment

Conditions: Pediatric Cancer; Pediatric Hematology

Summary: physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. we developed a tailored, 1:1, online physical activity program (i.e., impact), to promote physical activity in this cohort. the proposed single-group, mixed-methods project will assess the effect of impact and explore markers of implementation.


Eligibility criteria:
inclusion criteria: 1. children or adolescents between the ages of 5-18 years at enrollment and at least one parent (defined as a caregiver; biological or otherwise) 2. diagnosed with any oncological and/or hematological diagnosis 3. currently receiving or scheduled to receive any treatment for any oncological and/or hematological diagnosis or completed treatment \<3 months exclusion criteria: 1. completed all treatment for their oncological or hematological diagnosis \>3 months 2. unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist 3. parent and/or patient cannot understand verbal english 4. parent is unwilling to be present (i.e., at home, in the same room depending on participant age and functional ability) during the physical activity sessions (required to ensure safety of the child/adolescent)

Keywords: childhood cancer adolescent cancer in-patient out-patient oncology hematology
immediate versus delayed invasive intervention for non-stemi patients

Conditions: Myocardial Infarction

Summary: in patients with acute myocardial infarction without st-segment elevation on ecg (non-stemi), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. the benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. however, the question of optimal timing of routine invasive intervention remains unsolved. immediate invasive intervention early after admission for non-stemi may limit myocardial necrosis by securing the patency of the culprit coronary artery. nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early pci. the question of earlier versus delayed procedure in non-stemi patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure. the purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-stemi.


Eligibility criteria:
inclusion criteria: 1. episode of chest pain occurring no longer than 24 hours prior to admission 2. elevation of cardiac troponin i above the upper limit of normal (uln) 3. new st-segment depression at least 1 millivolt (mv) and/or t-wave inversion or transient st-segment elevation in ≥ 2 contiguous leads exclusion criteria: 1. age \< 18 years 2. persistent st-segment elevation 3. hemodynamic instability 4. cardiogenic shock on admission 5. life-threatening ventricular arrhythmias on admission 6. refractory angina on admission 7. active bleeding 8. any contraindication for the use of dual antiplatelet therapy (dapt) 9. presence of comorbidities with life expectancy \< 6 months

Keywords: non-stemi immediate delayed pci
atorvastatin (lipitor) to prevent bone pain

Conditions: Osteoporosis

Summary: in the proposed randomized double blind cross-over placebo controlled study, the researchers intend to investigate if atorvastatin (fda approved statin for children) can be used to alleviate the symptom of bone pain (acute phase reaction) that is commonly associated with initial doses of pamidronate or zoledronic acid, and also the mechanism that underlies this proposed beneficial effect of atorvastatin. the primary outcome studied will be alleviation of bone pain by atorvastatin compared to placebo by visual analogue pain scale in children treated with pamidronate or zoledronic acid. the secondary outcome investigated will be changes in blood count and γδt cell count, c-reactive protein (crp) and cytokine levels of interleukin 6 (il-6), tumor necrosis factor-alpha (tnf-α) and gamma interferon (γ-ifn) following treatment with atorvastatin compared to placebo.

the proposed study is a double blind cross-over placebo controlled randomized clinical study that would be conducted in the metabolic bone clinic of the children's mercy hospital. this is a pilot study and a more comprehensive study will be designed only if the results from this pilot study are significant. in our proposed double blind cross-over placebo controlled pilot study we will have a total of 12 children who will receive either placebo or atorvastatin in a randomized cross-over design. the pilot study with a sample of 12 in a cross-over trial will provide reasonably stable estimates even though it is unlikely to provide statistical significance on its own but will help plan further large scale studies.

Eligibility criteria:
inclusion criteria: * children with various metabolic bone diseases and osteoporosis who are to initiate treatment with either pamidronate and/or zoledronic acid. * they should be 6 to 25 years old, able to understand the study, swallow pills and competent to complete the visual analogue pain scale. exclusion criteria: * children less than 6 years old or incompetent to complete the visual analogue pain scale. * children with seizure disorder associated or triggered by fever. * children known to have hypersensitivity reaction to statins, active liver disease or persistent elevated serum transaminases or cpk. * children on erythromycin, cyclosporine, fibric acid, azole antifungals, cimetidine and spironolactone will be excluded.

Keywords: osteoporosis bisphosphonates atorvastatin
topical budesonide treatment for eosinophilic esophagitis (eoe)

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with eoe to determine if medication contact time and distribution in the esophagus relates to treatment response. the investigators will also determine if there is systemic absorption of these topical steroids. the investigators hypothesize that tissue and symptom response will correlate with esophageal medication contact time and distribution, and that significant systemic absorption will not be seen.


Eligibility criteria:
inclusion criteria: * new diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines) exclusion criteria: * age \< 18 * inability to read or understand english * pregnant or nursing women * previous allergic reactions to steroid medications * current use of systemic steroids

Keywords: eosinophilic esophagitis
patient specific peek versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty

Conditions: Mandible; Deformity

Summary: evaluation of polyetheretherketone (peek) versus titanium patient specific plates in the fixation of computer-guided advancement genioplasty.

aim: comparison between polyetheretherketone (peek) and titanium patient specific plates in the fixation of computer-guided advancement genioplasty. patients and methods: this study included fourteen patients indicated for advancement genioplasty. patients were assigned randomly into one of two equal groups. group a (control group) included seven patients who were treated by computer guided advancement genioplasty using patient specific titanium plates and group b(study group) involved seven patients who were treated by computer guided advancement genioplasty using patient specific peek plates.

Eligibility criteria:
inclusion criteria: * patients who are indicated to advancement genioplasty. * patients with completed growth. * physically and psychologically able to tolerate surgical procedures. exclusion criteria: * presence of any medical conditions that contraindicate the surgical procedure. * any medical condition that compromises the healing and surgical outcome.

Keywords: genioplasty peek mandible deformity
immuno-molecular approaches for non-invasive diagnosis of prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.

prostate cancer is one of the most frequently diagnosed cancers and a leading cause of cancer death in men worldwide. existing methods of diagnosis and monitoring of prostate cancer are inadequate due to their invasiveness, inaccuracy, cost, access uneven, etc., making difficult the diagnosis and patient's follow up. new techniques and methods are necessary to improve diagnosis. biological liquids might represent an attractive target to isolate prostate tumour cells for these purposes. in recent years, several studies have been carried out with the aim of reducing and / or avoiding the limits of sensitivity and specificity of current methods of screening for prostate cancer and thus obtain new biomarkers for the diagnosis and / or non-invasive monitoring. however, due to technical and technological difficulties few studies have been performed to investigate the non-invasive isolation and direct analysis of tumour cells. our project is therefore an innovative project which aims to study a new approach for the early diagnosis of prostate cancer, with better sensitivity and specificity.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of localized or metastatic prostate cancer. * no prior or other oncological treatment. * patients undergoing prostate biopsy in the context of prostate cancer diagnosis. * patients with an elevation of psa (prostate specific antigen), an abnormality on the rectal examination and / or an mri signal motivating a prostate biopsy, * patients informed and not opposed to participating in the research exclusion criteria: * patients not affiliated with french social security. * patients unable to understand the protocol. * patients diagnosed with another type of cancer within the past 5 years. * patients prostatectomized and/or treated for prostate cancer. * patients who wear a bladder catheter * patients under guardianship or curatorship * patients under ame

Keywords: prostate cancer liquid biopsy biological samples non-invasive diagnosis
a study of facilitators and barriers to improve acute kidney injury in children through mobile health intervention

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to improve patient-centered care for acute kidney injury (aki) in order to decrease the adverse health outcomes associated with this common condition.

there is a need to provide better patient-centered care for acute kidney injury (aki) in order to improve the adverse health outcomes associated with this common condition. this project involves thorough evaluation of patient and provider feedback on barriers and facilitators to pediatric aki self-management in order to develop patient-centered pediatric aki interventions. this will be done through interviews with families of patients diagnosed with aki and providers who take care of these patients followed by integration of the results into modification of an existing educational tool previously used in adult patients. the study will take place in three parts with the first involving interviews, the second involving tool modification and usability testing, and the third involving pilot testing of the tool's impact.

Eligibility criteria:
inclusion criteria: * age 1 to 18 years * patients with diagnosis of aki while hospitalized exclusion criteria: * legal blindness of deafness * cognitive impairment that limits ability to consent * non-english speaking * patient age greater than age 18 years, 11 months

Keywords: aki pediatric aki acute kidney injury
molecular & cellular characterisation of oral lichen planus

Conditions: Oral Lichen Planus

Summary: the principal research objective is to provide enhanced understanding of the cellular and molecular events important in the pathogenesis of oral lichen planus to enable improved diagnosis and development of novel treatments for patients.

the following questions will also be addressed: 1. are the histological architectural tissue changes that take place in oral lichen planus quantifiable using computer based imaging, graph theory and fractal geometry principles? quantification of these changes would allow the development of a tool to facilitate the accurate measurement of response to treatment. 2. what is the nature of such architectural changes and what are the differences with normal, dysplastic and neoplastic epithelia (the investigators have morphometrical data collected from previous research to allow such comparisons). 3. is it possible to produce evidence-based statistical classification into established diagnostic classes using the proposed methodology? this would contribute towards making histopathological diagnosis more quantitative, reproducible and accurate. 4. is it possible to automate such morphometrical analysis/classification? this would allow large data sets to be screened automatically in a shorter time frame and at lower cost than human based screening. 5. is it possible to determine differences in genetics and gene expression of keratinocytes involved in oral lichen planus compared to those of 'normal' tissue by using biopsy material and an in vitro model of oral lichen planus?

Eligibility criteria:
inclusion criteria: 1. patient is 16 years old or over 2. patient is willing and able to provide valid informed consent 3. patient is attending the oral lichen planus clinic and will be having a routine clinical biopsy taken exclusion criteria: 1. patient under 16 years old 2. patient is immunocompromised 3. patients with comorbid disease state e.g. other inflammatory disease
tap block versus local anesthesia wound infiltration for postoperative pain relief after appendicectomy in children

Conditions: Appendicitis Acute; Pediatrics; Analgesia

Summary: when performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. these techniques include local infiltration of the trocar wounds or transverse abdominal plane block (tap block). in 2018, a position paper of the european society of pediatric anaesthesiology advised for tap block over local infiltration of the trocar wounds. however, there is no randomized study comparing both techniques in children. the aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or tap block.

this is a double blind randomized study with two parallel groups. children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. informed consent will be asked for from the parents and the child. before surgery, patients will be randomized to either local infiltration of the trocar wounds or tap block using sequentially numbered sealed envelope each with a random number inside. patients with peritonitis will be excluded. a standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. secondary outcomes include postoperative pain (flacc assessment tool) and postoperative nausea and vomiting.

Eligibility criteria:
inclusion criteria: * age betwween 3 and 15 years * weight \< or = 50 kg * indicaction of coelioscopic appendicectomy * asa 1,2 or 3 * consent of the children and the holder of parental autority exclusion criteria: * age\ 15years or weight \> 50kg * refusal of the children and the holder of parental autority * asa 4 * peritonitis * patients with long term morphinic traitment * epilepsy * hepato-cellular insuffisiancy * local anesthesia allergy or nalbuphine allergy * coagulation abnomrmality * exclusion of health insurance

Keywords: appendicectomy laparoscopy infiltration tap block
wound healing: total contact cast vs. custom-made temporary footwear for patients with diabetic foot ulceration

Conditions: Neuropathic Foot Ulceration in Individuals With Diabetes

Summary: objective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes

in this prospective clinical trail, 43 patients with plantar ulcer grade 1 or 2 (wagner scale) were randomized to one of two off-loading modalities: total contact cast or custom-made temporary footwear.outcomes assessed were wound surface area reduction (square cm.)and time to wound healing (days0 at 2,4,8 and 16 weeks. to evaluate safety, possible side effects were recorded at each follow-up visit.

Eligibility criteria:
inclusion criteria: * confirmed diabetes * neuropathic ulcer grade 1/2 (wagner scale) * confirmed sensory neuropathy exclusion criteria: * osteomyelitis patients unable to walk * life threatening co-morbidity ankle/brachial index , 0.4

Keywords: neuropathic foot ulcerations - total contact cast - custom -made footwear - off-loading
acupuncture for recovery and postoperative nausea and vomiting after middle ear surgeries

Conditions: Treatment Complication

Summary: modern surgery management needs increasing operating room turnover and more ambulatory surgery. in order to come over this challenge, the recovery needs to be optimized. enhancing recovery could be achieved by preventing postoperative pain and postoperative nausea and vomiting. middle ear surgery is a common ambulatory surgery with increasing occurrence of postoperative nausea and vomiting.

sample size: as percent of vomiting following acupuncture and following standard anesthesia is 0.13% and 29.2% respectively so sample size is 58 (29 in each group). sample is calculated using open epi program with confidence level 95% and power 80%. patients in group c (control group) (n=29): will receive no treatment. while patients in group a (acupuncture group) (n=29): will receive needle acupuncture.

Eligibility criteria:
inclusion criteria: * written informed consent from the patient. * age: 21-60 years old. * sex: both sex (males or females). * physical status: asa 1\& ii. * bmi = (20-30 kg/m2). * type of operations: elective unilateral middle ear surgeries such as tempanoplasty, stapedectomy and mastedictomy. exclusion criteria: * altered mental state * patients with drug abuse or alcohol. * patients with on antipsychotic drugs, regular antiemetic therapy or receiving antiemetic 24 hour before surgery. * patients with pre-treatment with acupuncture or trigger point injection. * pregnancy.
early application of pulsed electromagnetic field in the treatment of postoperative delayed union

Conditions: Fracture; Delayed Union of Fracture

Summary: the investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.


Eligibility criteria:
inclusion criteria: * the failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture. exclusion criteria: * implant loosening or failure, infection, established nonunion, fracture gap greater than 5 mm, presence of implant within the fracture gap, metabolic disorders or received medication affecting fracture healing