Kornimate/medical-research-clean huggingface dataset:
decellularized, whole donor nipple-areola complex reconstruction grafts

Conditions: Breast Cancer

Summary: the goal of this study is to evaluate safety and healing time after nipple-areolar complex (nac) reconstruction with the bioaesthetics' decellularized human nipple-areolar complex (dcl-hnac) graft in patients who have had autologous breast reconstruction for breast cancer. secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following nac reconstruction surgery with the bioaesthetics' dcl-hnac graft.


Eligibility criteria:
inclusion criteria: * patient age 18-65 * patient desires nac grafting ≥3 months after autologous breast reconstruction * patient agrees to sleep on back until grafts healed (6 weeks) * patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks) * patient agrees to not undergo nac tattooing until completing study (12 months) * patient is able to understand and willing to sign informed consent. exclusion criteria: * history of delayed wound healing * history of vitamin c deficiency * history of diabetes (type i or type ii) * current bmi\ 40 kg/m, * patient has any other uncontrolled comorbidity. * patient has a history of allergic reaction to any decellularized biologic matrix product. * patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months. * patient is currently receiving radiation or chemotherapy or received radiation to the breast wall. * patient has a history of prior nac reconstruction * patient has had nac tattooing. * patient is pregnant, breastfeeding or planning to become pregnant during the study period.
comparative study of anterior tibial translation measurement by four laximeters in anterior cruciate ligament ruptures

Conditions: Anterior Cruciate Ligament Rupture

Summary: actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. the most commonly used are telos, kt-1000, gnrb and rolimeter. results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. the aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.


Eligibility criteria:
inclusion criteria: * obtaining a written informed consent of the patient, * affiliated with a medicare (or rightful beneficiary), * disponibility of the patient, * patients ≥ 18 ans, * anterior cruciate ligament rupture concerned only one knee of the patient. exclusion criteria: * patient is in the exclusion period for another study, * patient is under judicial protection, guardianship, or curators, * eligible patients who are refused to sign consent, * it is impossible to give clear informations to the patient, * pregnant women, * nursing mother, * patient which has been already operate of the other knee, * patient present ligament lesions associated.

Keywords: anterior cruciate ligament a02.835.583.512.100
application of monitoring and intervention technologies in suboptimal health status

Conditions: Suboptimal Health Status; Metabolic Abnormality

Summary: the purpose of this study is to use monitoring and intervention technologies in suboptimal health status in a general population in china and evaluate the effectiveness of these technologies in the improvement of suboptimal health status.

the suboptimal health status questionnaire (shsq-25) is used to evaluate the suboptimal health status. the shsq-25 includes 25 questions. the score of the shsq-25 is from 0 to 100. suboptimal health status is defined as the shsq-25 score above than 35. the higher scores of the shsq-25 one gets, the more severity of suboptimal health status he/she has. all participants are asked to fill in the shsq-25 before and after the intervention. if the score decreases after the intervention, it means that the suboptimal health status has been improved. a monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen saturation, body weight, and energy consumption by bluetooth wireless technology. intervention technologies include a health information push technology and a field-effect meridian therapy instrument.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 60 years. 2. written informed consent. exclusion criteria: 1. history of system diseases, such as cardiovascular diseases, digestive system diseases, diseases of respiratory system, blood and immune system diseases, nervous system diseases, endocrine system diseases, and diseases of the genitourinary system. 2. history of mental illness. 3. pregnant or breastfeeding. 4. use of antihypertensive, antidiabetic, or lipid-lowering drugs within the past two weeks. 5. participation in another trial. 6. unable to promise to not use drugs and other fish oils during the study. 7. unable to provide informed written consent.
natriuretic peptides after left atrial appendage amputation

Conditions: Atrial Fibrillation

Summary: surgical amputation of the left atrial appendage (laa) is an established intervention during surgical atrial fibrillation (af) therapy. however, its effects on the endocrine function of the left atrium are unclear. this study aims to quantify the serum levels of natriuretic peptides in patients who undergo concomitant surgical af ablation with or without laa amputation.


Eligibility criteria:
inclusion criteria: * indication for concomitant af therapy during cardiac surgery with cardiopulmonary bypass exclusion criteria: * lack of informed consent
induction and maintenance study of bms-936557 patients with moderate to severe ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to determine whether bms-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis


Eligibility criteria:
inclusion criteria: * clinical diagnosis of moderate to severe uc confirmed by endoscopic and histologic evidence * mayo score ≥6 with an endoscopic subscore of ≥2 * inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or tnf antagonist) exclusion criteria: * diagnosis of crohn's disease or indeterminate colitis * diagnosis of uc that is limited to the rectum * evidence of fulminant colitis, toxic megacolon, or bowel perforation * current need for a colostomy or ileostomy * previous total or subtotal colectomy
antibody response of a boosted japanese encephalitis chimeric virus vaccine (je-cv) in children

Conditions: Japanese Encephalitis

Summary: this study has aim to describe the immune response to the second dose of japanese encephalitis chimeric vaccine (jecv) in children previously vaccinated with one dose of jecv 5 years ago.

this is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of jecv 5 years ago.

Eligibility criteria:
inclusion criteria: 1. subject who was vaccinated with 1 dose je-cv in jec02 and participated in 5 year follow-up in jec05 trial and finished year 5 of follow-up. 2. provision of informed consent form signed by at least one parent or other legally acceptable representative. 3. subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures 4. in good general health, based on medical history and physical examination exclusion criteria: 1. participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except jec05 2. planned participation in another clinical trial during the day0-day28 period 3. receipt of live vaccine within 4 weeks preceding the trial vaccination 4. planned receipt of any vaccine in the 4 weeks following the trial vaccination 5. receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response 6. known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances 7. chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

Keywords: jecv imojev booster response children antibody response duration
short-term mri for treatment response evaluation/prediction of hcc treated with tare

Conditions: Hepatocellular Carcinoma

Summary: this study aims to investigate the value of early change at mri in hcc treated with tare, for evaluation/prediction of treatment response and prognosis.


Eligibility criteria:
inclusion criteria: * intermediate or locally advanced hcc according to hong kong liver cancer guideline * scheduled for transarterial radioembolization (tare) * sign informed consent exclusion criteria: * any absolute or relative contra-indication of contrast-enhanced mri * history of other local treatment before tare in 3 weeks

Keywords: mri
risk profile for patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes in the atrial tissue and which can help predict in which patients rhythm control will be successful. this risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. ultimately this risk profile can be used to guide type of rhythm control therapy in individual patients with atrial fibrillation.

atrial fibrillation is responsible for substantial morbidity and mortality.identification of patients with atrial fibrillation that is difficult to treat may improve the outcome of rhythm control therapy. left atrial size could be a useful tool to select patients that will benefit from rhythm control therapy.beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.it likes also plausible that recurrent atrial fibrillation within one month after start of rhythm control are associated with a different risk profile than late atrial fibrillation recurrence.during this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy.

Eligibility criteria:
inclusion criteria: * short-lasting symptomatic paroxysmal or persistent af; * rhythm control strategy is preferred; * no contra-indication for oral anticoagulation; * age \> 18 years; * written informed consent exclusion criteria: * total history of heart failure and/ or of severe valvular disease \> 3 years; * severe valvular disease; * acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month; * post-operative af.

Keywords: atrial fibrillation arrhythmia rhythm control
biventricular epicardial pacing post cardiac surgery in patients with left ventricular ejection fractions less than 45%

Conditions: Heart Failure

Summary: patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. a significant portion of these patients require postoperative pacing. right ventricular pacing has been shown to be hemodynamically deleterious the aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (ef≤ 45%), is hemodynamically favourable.

some patients with left ventricular systolic dysfunction (lvsd) have an inefficient pumping function. these patients have been shown to benefit from a device therapy known as biventricular pacing. biventricular pacing causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure. cardiac resynchronization therapy (crt) has established itself as a proven therapy for congestive heart failure in adults, patients showing improvement in exercise tolerance, quality of life, and survival. in cardiac surgery, a significant number of these patients with left ventricular systolic dysfunction require postoperative pacing. right ventricular pacing has been shown to be hemodynamically deleterious whether biventricular pacing in patients with lvsd improves patient outcomes after heart surgery has not been investigated. the aim of this crossover trial is to compare conventional ventricular pacing and ddd-biventricular in post operative patients with a pre operative ejection fraction less than 45%, in a prospective randomized setting. we would like to determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular, immediately after heart surgery in patients with lvsd will improve the heart function. immediately after surgery, the patients will receive atrio ventricular conventional right ventricular pacing, or biventricular pacing depending upon the treatment arm that they were randomized to. the primary end point is a 15 % improvement in index cardiac measured by thermal dilution and/or echocardiography in intensive care unit. furthermore, plasma n-terminal pro-brain natriuretic peptide (nt-probnp), cardiac troponin t (ctnt), will be measured in patients undergoing elective cardiac surgery 12 h, 24 h, 48 h and 72 hours after. this study is important because of a high probability of clinical benefit.

Eligibility criteria:
inclusion criteria: * planned cabg and/or valve surgery * left ventricular dysfunction (ef≤ 45%) * age \> 18 years * able to give written information consent exclusion criteria: * existing permanent pace maker * atrial fibrillation * enrolment in other research protocols * inability to give written informed consent * heart transplant * pre operative cardiovascular instability

Keywords: biventricular pacing resynchronisation therapy cardiac surgery ejection fraction of less 45%
evaluating in vivo oct imaging for periocular basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: optical coherence tomography (oct) is an imaging technique which shows the internal structure of living tissue (in vivo). it is safe, quick and painless to perform, and does not damage the tissue in any way. recent advances in the technology mean that it can now be used to take images of the internal structure of the skin. this is useful because certain conditions, such as skin cancers, alter this structure. at present a suspected skin cancer is identified by taking a sample (a biopsy) which is analysed under the microscope to confirm the diagnosis. the cancer is then excised including a margin of apparently healthy-looking skin around it to ensure that the entirety of the tumour is removed. the excised tumour is then analysed again under a microscope to confirm that it was indeed completely removed (histology), after which a further operation is required to repair the defect. the purpose of this study is to evaluate oct imaging of a particular type of skin cancer called a basal cell carcinoma (bcc), and in particular bccs affecting the skin around the eyes (periocular). the study will compare the ability of oct to define the margin of the bcc with the current 'gold standard' of histology. oct could potentially improve the investigators ability to define the margins of the tumour before surgery and become a guide for minimally invasive surgery. the preservation of healthy tissue represents a priority, particularly in the area of the skin surrounding the eye.


Eligibility criteria:
inclusion criteria: * adults of any age or gender who have capacity to give informed consent, and who have periocular basal cell carcinoma requiring surgical excision exclusion criteria: * children, vulnerable adults, inability to give informed consent

Keywords: basal cell carcinoma optical coherence tomography
white blood cell counts and onset of cardiovascular diseases: a caliber study

Conditions: Abdominal Aortic Aneurysm; Coronary Artery Disease; Stroke; Heart Failure; Peripheral Arterial Disease

Summary: the complete blood count is a commonly performed blood test, and previous small studies have suggested that the counts of some types of white blood cell in the complete blood count may be related to the onset of cardiovascular diseases such as stroke and heart attack. this is of interest because this information may help to predict strokes or heart attacks and may guide new therapies which act on white blood cells to reduce the risk of cardiovascular disease. the hypothesis is that counts of particular types of white blood cell are associated with a range of cardiovascular diseases.

there is evidence from epidemiological studies that counts of some types of white blood cell, such as neutrophils, are associated with increased incidence of coronary disease. associations with other initial presentations of cardiovascular diseases have not been studied in large cohorts, but may be of interest for use in risk prediction or to guide therapeutic strategies. the aim of this study is to estimate associations between counts of lymphocytes, neutrophils, eosinophils, monocytes and basophils, and initial presentation of a range of cardiovascular diseases. the study will use data from the caliber dataset of clinically collected electronic health record data from england. patients enter the study when they have a full blood count (complete blood count) recorded in the dataset, and they are followed up until they experience one of the cardiovascular endpoints, death or transfer out of the participating primary care practice. this study is part of the caliber (cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the national institute for health research (nihr) and wellcome trust. the central theme of the caliber research is linkage of the myocardial ischaemia national audit project (minap) with primary care (clinical practice research datalink) and other resources. the overarching aim of caliber is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. caliber has received both ethics approval (ref 09/h0810/16) and ecc approval (ref ecc 2-06(b)/2009 caliber dataset).

Eligibility criteria:
inclusion criteria: * all patients aged 30 and over, registered with a participating general practice during the study period. exclusion criteria: * patients without a measurement of full blood count during the study period. * patients with prior atherosclerotic disease, as recorded in primary care or hospitalisation data.

Keywords: neutrophil lymphocyte eosinophil leukocyte count cardiovascular disease atherosclerosis monocyte basophil
feasibility study on litt for newly diagnosed glioblastoma

Conditions: Glioblastoma

Summary: multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (litt) ablation using the monteris neuroblate system in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (gbm).


Eligibility criteria:
relevant inclusion criteria: 1. biopsy proven supratentorial gbm that has not undergone previous surgical resection, radiation and/or chemotherapy 2. single enhancing lesion that is \>1 cm, but \< 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm) 3. the patient must be ≥18 years of age 4. kps \> 70 5. patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. patients with prior malignancies must be disease-free for five years. 6. stable cardiovascular, pulmonary health status relevant exclusion criteria: 1. seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs 2. symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant 3. uncontrolled cardiovascular conditions of hypertension (systolic \>180 mm hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage 4. serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements 5. pregnancy, or planning to become pregnant 6. patients whose physical dimensions cannot be accommodated in the mri scanner or patients with contraindications to mri imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects 7. patients with multiple or multifocal gbm

Keywords: glioblastoma neuroblate litt quality of life
supportive effects of craniosacral therapy for female patients with breast cancer and their partners

Conditions: Breast Cancer; Complementary Therapies

Summary: craniosacral therapy (cst) is a non-manipulative, very gentle, manual treatment method that aims to release restrictions of the fasciae and regulate the arousal of the sympathetic nervous system, which is often increased in chronically ill patients. initial randomized trials support cst's efficacy and effectiveness in reducing symptoms of patients with psychosomatic and chronic pain disorders. to date, there is no trial investigating the effectiveness of cst as a supportive strategy for enhancing cancer-related quality of life in women with breast cancer. in clinical practice, therapists also report alleviating as well as regulating effects of simple cst self-help techniques, offered to patients within a group concept. within the recent study, a cst treatment and self-help protocol for women after curative therapy of breast cancer was developed and shall be tested against a waiting list control group. the first group will receive 24 units of cst treatment in a 1:1 setting with a certified craniosacral therapist over 12 weeks. the second group will receive 24 units of group training in cst self-help techniques offered by a certified craniosacral therapist over 12 weeks. they will be reassessed after 12 and 26 weeks (6 months) after randomization. the third group will wait for 26 weeks and will receive no specific study intervention. after 26 weeks patients of the third group were offered to take part in two individual cst interventions and the cst self-help training. for all groups, treatment as usual is allowed.


Eligibility criteria:
inclusion criteria: * breast cancer (stage i-iii) survivors after finishing curative chemotherapy and/or radiation * impaired breast caner-related quality of life (\< 112,8 points on the fact-b) exclusion criteria: * planned surgery, adjuvant therapy (chemotherapy and/or radtiation), or rehabilitation during the study period * pregnancy * simultaneous participation in other clinical trials

Keywords: craniosacral therapy breast cancer randomized controlled trial self-help strategies self-efficacy coping