Kornimate/medical-research-clean huggingface dataset:
a pilot study to examine the role of nitazoxanide to prevent recurrence of hepatitis c after transplantation

Conditions: Hepatitis C Recurrence

Summary: recurrence of hepatitis c virus infection (hcv) is universal after orthotopic liver transplantation (ltx) and is associated with allograft failure, death and need for re-transplantation. currently, there are no effective therapies to prevent hcv recurrence. nitazoxanide (ntz), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic hcv genotype 4. its role in the prevention of hcv recurrence after liver transplantation has not been studied. the investigators propose to conduct an open label pilot study examining the role of ntz in the prevention of hcv re-infection in eight patients undergoing ltx. first time transplant recipients for chronic hcv without history of renal failure or hiv/hbv co-infection, will receive ntz immediately prior to ltx and for 3 days thereafter. the primary endpoint is the number of patients who remain hcv-rna-negative at day 7 after ltx. if at least one patient remains negative, the study will be determined to be positive. additionally, the investigators will examine the viral kinetics of hcv, tolerability and safety of ntz.

recurrence of hepatitis c virus infection (hcv) is universal after orthotopic liver transplantation (ltx) and is associated with allograft failure, death and need for re-transplantation. currently, there are no effective therapies to prevent hcv recurrence. nitazoxanide (ntz), an oral thiazolide anti-infectious agent, was safe, well tolerated and effective in achieving sustained viral response in patients with chronic hcv genotype 4. its role in the prevention of hcv recurrence after liver transplantation has not been studied. we propose to conduct an open label pilot study examining the role of ntz in the prevention of hcv re-infection in eight patients undergoing ltx. first time transplant recipients for chronic hcv without history of renal failure or hiv/hbv co-infection, will receive ntz immediately prior to ltx and for 3 days thereafter. the primary endpoint is the number of patients who remain hcv-rna-negative at day 7 after ltx. if at least one patient remains negative, the study will be determined to be positive. additionally, we will examine the viral kinetics of hcv, tolerability and safety of ntz.

Eligibility criteria:
inclusion criteria: * adult male or female patients age 18-75 * hcv infection identified by positive, quantifiable hcv rna prior to transplant exclusion criteria: * scheduled recipient of living donor transplantation * history of chronic hepatitis b or hiv infection * transplantation for fulminant hepatic failure * estimated glomerular filtration rate \<60ml/min * women who are pregnant or breast feeding and men or women that are sexually active but do not agree to use acceptable birth control

Keywords: nitazoxanide liver transplantation hcv recurrence
comparative study of through knee amputation versus above knee amputation regarding infection rate and function

Conditions: Amputation of Knee

Summary: the aim of this study is to search and compare outcomes of through knee amputation (tka) and above knee amputation (aka) in terms of technique ,wound healing ,infection rate , function and ambulation

severe peripheral arterial disease with or without comorbid diabetes mellitus accounts for the majority of patients requiring major lower extremity amputations. there is also an association between major extremity amputation and lower socio-economic status, attributed to lifestyle and comorbidities, living and working conditions, psychosocial factors, and access to affordable healthcare. with a transfemoral prosthesis, the amputee weight bears through their ischial tuberosity which can cause discomfort when standing or ambulating. these challenges have been associated with greater abandonment of prosthesis use. an often over looked alternative within amputation surgery is through knee amputation (tka), which currently comprises less than 5% of all major lower extremity amputations. compared with aka, tka is a less traumatic procedure with little disruption to thigh muscles, articular cartilage, menisci, and bone (especially with knee disarticulation), which in turn reduces post-operative infection and formation of bone spurs. in contrast, aka can also provide additional problems. due to a shorter lever length of the residuum, the unilateral transfemoral amputee requires three times more energy to ambulate with a prosthetic limb compared with a unilateral transtibial amputee. among vascular surgeons, tka is similarly rarely performed. fear of poor wound healing and potential stump breakdown in longer soft tissue flaps needed to cover epicondyles of the distal femur are possible preconceived misconceptions. historically, outcomes after tka are acceptable, but scarce vascular literature exists reporting contemporary outcomes of tka.

Eligibility criteria:
inclusion criteria: * critical limb ischemia with sever infection with no role for bka * acute late or total ischemia sfa with poor * popliteal signals and no distal run off * infected diabetic foot (df) affecting heel and calf muscle with preserved knee joint * traumatic gangrene exclusion criteria: * venous gangrene
effects of internet-based erita added to tau in young people with non-suicidal self-injury (teens) feasibility trial

Conditions: Non-suicidal Self-injury

Summary: there has been a significant increase in non-suicidal self-injury the last decades especially among young people and treatment initiative are sparse. we aim to assess the feasibility of methods, procedures, and safety of internet-based emotion regulation individual therapy for adolescents (erita) as add on to treatment as usual (tau) in 13-17-year-old patients with non-suicidal self-injury referred to psychiatric services.

non-suicidal self-injury has disseminated almost epidemically through the last decades in young persons. there is no evidence of any experimental treatment for non-suicidal self-injury in adolescents, superior to treatment as usual. patients with stigmatizing illness such as non-suicidal self-injury may find internet-based interventions more acceptable. the study is a feasibility trial, with a randomization procedure in a parallel group design. patients will be recruited from child- and adolescent mental health services (age 13 to 17 years). the experimental intervention is internet-based, and therapist guided; erita consists of online emotion regulation individual therapy for adolescents (erita) as add-on to treatment as usual. treatment as usual is provided by multidisciplinary teams in nine outpatient clinics within child and adolescent mental health services in the capital region of denmark. feasibility of recruitment and trial procedures will be monitored as well as explorative clinical outcomes.

Eligibility criteria:
inclusion criteria: * ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month (dsm-5 criteria for a diagnosis of non-suicidal self-injury disorder in terms of frequency of nssi). * age-appropriate literacy. * having at least one parent committing to participate in the parent program. * informed consent from parents/legal caretakers. exclusion criteria: * imminent suicidal risk assessed by clinicians during routine screening procedure (rated as no risk, elevated risk, imminent risk) in need of admission or other life saving strategies.

Keywords: non-suicidal self-injury internet-based intervention
shared healthcare actions and reflections electronic systems in survivorship

Conditions: Cancer; Survivorship; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: the primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.

primary objectives: • to evaluate how successfully share-s can be implemented into clinical care as characterized by rates of enrollment. investigators hypothesize \>30% of patients e-referred to share-s will enroll. secondary objectives: * to assess additional implementation outcomes that evaluate preliminary implementation success (i.e., further assessment of adoption, acceptability, appropriateness, further assessment of feasibility, and fidelity). * to describe service outcome variability to inform future studies. investigators will assess service outcomes relevant to commission on cancer requirements by reporting annual estimates for: (1) the estimated number of patients impacted by share-s; (2) the cancer sites impacted by share-s; and the (3) resources/processes utilized to enhance each of the chosen services if barriers were encountered. we will also assess safety and perceived patient-centeredness of care. * to describe patient health outcome variability to inform future studies (i.e., social role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain, cancer-specific quality of life, health behaviors, patient autonomy, self-efficacy for managing cancer, engagement with the survivorship care plan document, and satisfaction with care). * to evaluate the implementation program we will assess key milestones and processes for this pilot study of the implementation stage measured at the clinic level. * to qualitatively assess implementation barriers and facilitators using semi-structured interviews that will be audio-recorded. * to examine how study results vary by cancer type.

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * documented or planned cancer survivorship visit * have a texting enabled telephone * cognitively able to complete study procedures as judged by the study team * able to understand, read and write english children under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. results from this research may inform future studies in children with cancer under 18 who should be researched separately. exclusion criteria - declined participation in the study
hepatic arterial infusion of oxaliplatin and fluorouracil treatment of advanced primary liver cancer after tace

Conditions: Advanced Adult Primary Liver Cancer

Summary: to investigate the therapy effect and security of oxaliplatin and fluorouracil on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer


Eligibility criteria:
inclusion criteria: 1. with written informed consent 2. age ranged from 18 to 80 years, both men and women 3. confirmed by pathology or clinical diagnosis of liver cancer 4. progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy 5. never received tace treatment 6. (m) recist 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm, 7. ecog ps score of ≤2 8. expected survival time ≥12 weeks 9. the test results before 7 days entered the group must meet the following requirements: hemoglobin ≥ 90 g / l absolute neutrophil count (anc)\> 1,500 / mm3 platelet count ≥ 80x109 / l serum alanine aminotransferase (alt) and aspartate aminotransferase (ast) \<5 times the upper limit of normal (unl) total bilirubin \<3unl serum creatinine \<1.5 unl pt or inr, ppt \<1.5 unl (for patients undergoing warfarin or heparin anticoagulant therapy, if there is no evidence that there is an abnormality of the above parameters, you can enter the group, but must be closely monitored to detect at least once a week until the inr stable) exclusion criteria: 1. specific circumstances of patients not suitable for tace therapy / chemotherapy 2. hepatic decompensation, or the presence of hepatic encephalopathy 3. before entering the study with gastrointestinal bleeding within 30 days 4. presence of brain metastasis 5. pregnant or lactating women 6. active bleeding or sepsis 7. history of heart disease: nyha two or more of congestive heart failure, symptomatic coronary artery disease need to use β-blockers or digoxin medication other than arrhythmias 8. despite treatment, still systolic blood pressure\> 150 mmhg or diastolic blood pressure\> 90 mmhg hypertension 9. not cure severe trauma, acute or incurable ulcer, or three months fracture 10. the researchers believe their poor compliance 11. exist once or primary lesion or histologically different tumors and colorectal cancer, except: head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder cancer (ta, tis, t1), and the group 3 years ago, it has been cured of cancer 12. hiv infection or the presence of aids-related illness, or severe acute and chronic diseases 13. drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders 14. need drug therapy epilepsy (such as steroids or antiepileptic drugs 15. chemotherapy contraindications exist 16. any instability or likely to endanger the patient in this study the safety and compliance of the case

Keywords: tace; oxaliplatin; fluorouracil; liver cancer
women's health initiative silent atrial fibrillation recording study

Conditions: Atrial Fibrillation

Summary: the purpose of the whish star study is to investigate whether or not those who are randomized to exercise intervention have higher rates of atrial fibrillation on review of medical records and, in a subset, on screening with a cardiac ecg patch monitor. we will also study whether those with a known history of af have any changes in af hospitalizations due to exercise.

the silent atrial fibrillation recording study (star) study is an ancillary study of the nih-funded women's health initiative strong and healthy (whish). the purpose of the women's health initiative strong and healthy study (whish) is to investigate if light to moderate exercise decreases incident atrial fibrillation (af) among women over 65 who have no baseline af. the purpose of the star study is to investigate the effect of exercise intervention on incident atrial fibrillation ascertained with diagnostic codes. in a subset of women, subclinical atrial fibrillation will be ascertained with cardiac patch ecg monitoring technology (irhythm's zio® xt patch). this subgroup of whish study participants will undergo an 8 day cardiac patch recording at baseline, six (6) months, and one (1) year.

Eligibility criteria:
inclusion criteria: * subjects already enrolled in the parent whish study. * subjects who are at high risk of developing atrial fibrillation. exclusion criteria: * subjects who have had atrial fibrillation at baseline.
fluorescence and reflectance spectroscopy during colposcopy in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal pap smears

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: new diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninvasively detect cervical intraepithelial neoplasia and dysplasia. purpose: this diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal pap smears.

objectives: * identify potential improvements in noninvasive methods of diagnosing dysplasia and neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy participants with a history of normal pap smears. * determine the reflection and fluorescence spectra of in vivo samples of the normal human cervix. * refine the detection of cervical lesions by fluorescence spectroscopy in these participants using improved classification of normal columnar tissue and non-neoplastic tissue with inflammation. * determine and validate the wavelength selections for spectroscopic diagnosis derived from in vitro measurements from these participants. * compare specific tissue sections from these participants with their excitation-emission matrices in order to identify the cell types contributing to the signal. outline: participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy\*. the probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. participants undergo biopsies of both sites. note: \*the columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured projected accrual: a total of 1,000 participants will be accrued for this study.

Eligibility criteria:
inclusion criteria: 1. subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth. 2. subjects must sign an informed consent indicating awareness of the investigational nature of this study. exclusion criteria: 1) pregnant individuals will be ineligible for this study.

Keywords: cervical cancer cervical intraepithelial neoplasia
a 44-week monocentric open study assessing the efficacy and safety of deucravacitinib in adults with inflammatory genodermatoses

Conditions: Epidermolysis Bullosa Simplex; Ichthyosis; Genodermatosis; Inflammatory Congenital Ichthyoses

Summary: the goal of this clinical trial is to learn about deucravacitinib treatment in adults with inflammatory epidermal genodermatoses . the main question it aims to answer are: describe efficacity and safety of this treatment. participants will take treatments and have to use bullets during the study period.

the patient will have 8 visits after confirmation of inclusion criteria and no exclusion criteria, the study will be explain to the patient after signing the inform consent and be included in the study treatment period (period 1); challenge period this period will be the first treatment period that will occur from 16 weeks. during this period the patient will see the doctor at the hospital, he will perform the study procedures the second period : dechallenge (period 2): all patients stop their treatment for 12 weeks. the second treatment period - rechallenge (period 3) the patient will take the treatment for a second 16 weeks period at week 44 - end of study at each visit: the investigator at each visit compliance to the treatment and adverse events, measure vital signs and perform clinical examination. the patient will assess the different questionnaires, for the study and have blood sample

Eligibility criteria:
inclusion criteria: * subject has congenital skin fragility with skin and/or mucosal blisters, a clinical phenotype of ebs-sev and a laboratory confirmed diagnosis of ebs by krt5 and/or 14 mutation (autosomal only) or a clinical phenotype of inflammatory ichthyosis (ic) including keratinopathic ichthyosis due to krt1/10 mutation, eci with identified genetic mutations (tgm5, nipal4, abca12, etc...). * subject has at least a mean daily number of 4 new blisters (ebs-sev) or an iss \> 50/128. * subject agrees not to use any topical therapies other than the investigator approved. exclusion criteria: * subjects with another form of ici ie netherton syndrome, kid syndrome etc. * infectious/immune-related exclusions * medical history and concurrent diseases

Keywords: deucravacitinib
q value customized versus wavefront optimized ablation in femtosecond laser-assisted lasik

Conditions: Patients With Myopic Spherical Equivalent up to -12 Diopters

Summary: corneal asphericity is expressed numerically as the "q-value". a minus value means that corneal curvature flattens towards the periphery and the cornea is prolate in shape, but when the curvature steepens towards the periphery, the cornea is oblate in shape and has a positive q-value. the current study evaluates the effect of lasik eye surgery on corneal asphericity by comparing 2 software treatment platforms; the q value customized ablation versus the conventional wave-front optimized ablation in a fellow eye study pattern.

the standard excimer laser correction of myopia is associated with decreased visual quality in the form of a decrease in contrast sensitivity and night vision. this degradation of the visual quality is attributed to changes in the corneal asphericity that increase the high order aberrations (hoas), such as spherical aberrations because it leads to shifting of the corneal asphericity towards the oblate shape. the wavefront-optimized (wfo) profile avoids the creation of new hoas, but it is not able to treat those which are already present pre-operatively. the q-adjusted treatments correct the sphero-cylindrical refractive errors and try to maintain the corneal asphericity at the same time, but like the wfo ablation profiles, it is limited to correcting the spherical aberrations and not the non-rotational symmetric hoas. some studies compared lasers of two different platforms on contralateral eyes of the same patient in order to minimize inter-patient differences such as corneal wound healing and corneal biomechanics. by exclusion of these inter-patient differences, a more accurate judgment on the outcomes can be achieved.

Eligibility criteria:
inclusion criteria: candidates for laser vision correction (lvc) with 1. myopic spherical equivalent up to -12 diopters. 2. myopic astigmatism up to -6 diopters. 3. corneal thinnest location ≥ 500 um 4- residual stromal bed ≥ 300 um. exclusion criteria: 1. patients not candidates for lvc. 2. hyperopic patients or mixed astigmatism. 3. systemic disease that contraindicates lvc. 4. intra- or post-operative complications. 5- previous corneal surgery

Keywords: femtosecond lasik q value wave-front optimized (wfo)
nuts and extra virgin olive oil pilot study

Conditions: Hypertension

Summary: this study is designed to test the feasibility of asking older adults with high blood pressure to supplement their daily diets with walnuts and extra-virgin olive oil.

even though cardiovascular disease (cvd) continues to be the leading cause of death in the united states, americans have yet to widely adopt evidence-based dietary modifications necessary to reduce cvd risk factors. encouraging evidence from the prevención con dieta mediterránea (predimed) trial indicates that adding olive oil and nuts to the diets of older adults in spain substantially impacted cvd risk factors and events. a large trial testing evoo and nuts in a u.s. population is needed to determine if supplementing with evoo and nuts can reduce risk of cardiovascular events and mortality in adults living in the u.s. prior to launching a large trial, it is important to assess whether adults 55 and older would be interested in participating in a supplementation trial such as predimed. additionally, it is important to assess if they are willing to consume the nuts and evoo and attend study related-data collection visits.

Eligibility criteria:
inclusion criteria: * being treated for hypertension-defined by being prescribed at least one hypertension medication; willing to comply with study visits, as outlined in the protocol; able to read and speak english; no allergies or hypersensitivities to olive oil or nuts; ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * plans to move from the study area in the next 8 weeks; dementia that is medically documented or suspected; homebound for medical reasons; cancer diagnosis and/or treatment in the last 3 years.