Kornimate/medical-research-clean huggingface dataset:
radiomics compared with conventional response criteria for predicting progression of desmoid tumor after cryoablation

Conditions: Desmoid

Summary: desmoid tumors (dt) are uncommon tumors that arise from musculoaponeurotic structures. despite benign, they can cause pain and disability due to their tendency to be locally aggressive. cryoablation, a technique used in interventional radiology, has gained popularity in recent years as a treatment option for sporadic dt. this involves repeated cycles of freezing, leading to cell death. recent studies showed that percutaneous image-guided cryoablation appears to be safe and effective for local control for patients with extra-abdominal desmoid tumors.although changes in the heterogeneity of tumors are commonly known, they are often ignored in response criteria that only evaluate tumor size in a single dimension, such as response evaluation criteria in solid tumors (recist 1.1). nevertheless, mri can reveal early changes in tumor heterogeneity in responding tumors, resulting from a reduction in cellular area and an increase in fibro-necrotic content, before any dimensional changes occur. these changes in heterogeneity can be quantified using a radiomics approach. the aim of this study is to develop radiomics response criteria dedicated to the evaluation of dt treated with cryoablation as a first line treatment and to compare their performance with those of alternative radiologic response criteria for predicting progression according to recist 1.1.


Eligibility criteria:
inclusion criteria: * desmoid tumor treated at rizzoli orthopaedic institute with cryoablation * baseline mri * clinical and radiologic follow-up until disease progression or the start of a new line of treatment performed every 3 months, with a minimum of 6 months follow-up exclusion criteria: - not meeting inclusion criteria
pilot study of high dose liposomal amphotericin b efficacy in initial zygomycosis treatment

Conditions: Zygomycosis

Summary: evaluation after 4 weeks of treatment or at end of treatment if it occurs before. efficacy will be defined as objective responses; complete and partial response.

primary objective: efficacy of 4 weeks of liposomal amphotericin b (ambisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose in initial zygomycosis treatment. evaluation after 4 weeks of treatment or at end of treatment if it occurs before. efficacy will be defined as objective responses; complete and partial response. secondary objectives: efficacy, tolerance and survival after 15 days of treatment, cumulative dose of ambisome® necessary to obtain objective response, efficacy in operated and non operated patients, tolerance after 4 and 12 weeks treatment, survival, and relapse rate at 6 months of 4 weeks of liposomal amphotericin b (ambisome®) at high dose \[10 mg/kg/j\] or at maximal tolerable dose. scheme : prospective, multicentric, non comparative therapeutic pilot study. inclusion criteria: presence on a tissue biopsy of large non septated hyphae compatible with zygomycete or presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection. exclusion criteria: life expectancy below 72 hours, pregnancy, breast feeding, polyene hypersensitivity, absence of histologic or mycologic zygomycosis documentation, absence of informed consent, previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion. treatment : ambisome® 10 mg/kg/j monotherapy during at least 15 days, then ambisome® at maximal tolerable dose during 15 days associated with early optimal surgical treatment. after the first treatment month, following treatment is decided by referent physician.

Eligibility criteria:
inclusion criteria: * presence on a tissue biopsy of large non septated hyphae compatible with zygomycete * presence of a zygomycete in culture associated with clinical or radiological abnormalities compatible with fungal invasive infection. exclusion criteria: * life expectancy below 72 hours, * pregnancy, breast feeding, * polyene hypersensitivity, * absence of histologic or mycologic zygomycosis documentation, * absence of informed consent, * previous treatment with polyene or other antifungal active on zygomycete (posaconazole, itraconazole) over 5 days during the month previous inclusion

Keywords: zygomycosis high dose liposomal amphotericin b
closed loop insulin therapy in type 1 diabetics based on blood microdialysis, online sensors and an empc algorithm

Conditions: Type 1 Diabetes

Summary: the eu funded project clinicip (closed loop insulin infusion for critically ill patients) aims to develop a low-risk monitoring and control device which allows maintaining metabolic control in intensive care units. a system will be developed comprising three subsystems: a body interface for the delivery of biofluids, biosensors for the determination of glucose concentration in these biofluids and an adaptive control algorithm that generates advice and thus represents a decision support system with respect to insulin infusion rate to establish glycaemic control in critically ill patients. within a closed loop system, intensified insulin treatment will make use of the calculations leading to external regulation of glucose. it is the aim of this study to evaluate the feasibility to establish glycaemic control in type 1 diabetic subjects over a period of 30 hours by manually combining these three - previously tested - subsystems (abs system, extracorporeal online glucose sensor and a laptop-based computer algorithm).


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any trial-related activities * age of analysable subjects in the range from 18 to 65 years * type 1 diabetes (treatment with multiple daily injection for more than 12 months) exclusion criteria: * severe acute and/or chronic diseases * mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * taking of any vasoactive substances or anticoagulation medication. * diseases of the skin which could interfere with application of the catheters. * pregnancy or breastfeeding * bleeding disorder * known heparin allergy or heparin intolerance

Keywords: blood microdialysis glucose monitoring glucose control automated blood sampling online-sensor algorithm type 1 diabetes
evaluation of a distraction-rotation knee unloader brace in patients with medial knee osteoarthritis.

Conditions: Knee Osteoarthritis

Summary: the aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * patient understanding simple order and able to give written consent. * man or woman with age between 40 et 75 years * unilateral medial symptomatic knee osteoarthritis, defined using the american college of rheumatology classification * radiologic grade ii, iii ou iv (kellgren et lawrence (kl) classification) * medial knee compartment (medial k\&l g rade higher than lateral k\&l grade * knee pain \> 40/100 on visual analog scale and \<30/100 for the other * no change in medical treatment for at least 3 months. * latest radiographic image \< 12 months before inclusion exclusion criteria: * patient without healthcare insurance. * inflammatory knee arthritis, * indication of knee surgery * pregnancy, breastfeeding * associate neurologic or orthopaedic affection that interferes with gait analysis * rapidly destructive arthritis. * alzheimer's disease, parkinson's disease, motor neuronal disorders * patient under guardianship or tutelage
use of fresh platelet rich plasma with concentrated leukocytes or fresh platelet rich plasma without concentrated leukocytes in the treatment of knee cartilage degeneration: a randomized controlled trial

Conditions: Osteoarthritis, Knee

Summary: the aim of the study is to compare the triple infiltration of fresh platelet rich plasma with concentrated leukocytes against triple infiltration of fresh platelet rich plasma without concentrated leukocytes in the treatment of knee cartilage degeneration in a double blind randomized controlled trial

platelet rich plasma has a consolidated use in the field of orthopedic surgery to reduce inflammation, promoting bone regeneration and healing of surgical wounds. some clinical studies demonstrated the utility of the intra-articular infiltration of platelet rich plasma in the treatment of knee articular cartilage lesions, becoming a common conservative strategies in the management of these diseases. actually, there are some different kinds of prp formulations, in particular, the scientific debate is focusing on the role of leukocytes and if it is better using fresh or frozen prp. at the moment don't exist randomized controlled clinical studies comparing fresh prp rich in leukocyte against prp poor in leukocyte in the treatment of knee cartilage lesions. the study has two groups of patients, the first will undergo to three infiltrations of fresh platelet rich plasma with concentrated leukocytes and the second will undergo to three infiltrations of fresh platelet rich plasma without concentrated leukocytes, each infiltrations will be done weekly.

Eligibility criteria:
inclusion criteria: patients with degenerative pathology of the knee cartilage with: 1. age between 18 and 75 years; 2. unilateral involvement; 3. signs and symptoms of degenerative pathology of the cartilage of the knee; 4. radiographic or mri signs of degenerative pathology of the cartilage of the knee (kellgren-lawrence 1-4 degrees); 5. hemoglobin\> 11 g / dl; platelet count\> 150,000 plt / mm3 (recently performed blood count); 6. no clinically significant electrocardiographic alteration (recently performed ecg). 7. patients' ability and consent to actively participate in clinical follow-up; 8. signature of informed consent. exclusion criteria: 1. patients undergone to intra-articular infiltration of another substance in the previous 6 months; 2. patients undergone knee surgery in the previous 12 months; 3. patients with malignant neoplasms; 4. patients suffering from rheumatic diseases; 5. patients suffering from diabetes; 6. patients with hematologic diseases (coagulopathies); 7. patients on anti-anticoagulant therapy; 8. patients suffering from thyroid metabolic disorders; 9. patients abusing alcoholic beverages, drugs or drugs; 10. body mass index\> 35; 11. patients who have taken nsaids within 3 days before taking blood; 12. patients with cardiovascular diseases for which the 150 ml blood test would be contraindicated; 13. patients with a recently performed blood count with hb values \<11 g / dl and platelets \<150,000 plt / mm3.
efficacy of synex wound rinse in civilian surrogates of combat injury wounds

Conditions: Wound Heal

Summary: the purpose of this interventional study is to compare synex wound cleanser with the current routine care (saline) in traumatic wounds. participants with gunshot, penetrating or burn wounds who participate will be asked to attend up to four study visits, use the assigned wound cleanser and complete brief surveys about their healing and well-being related to the wound healing.


Eligibility criteria:
inclusion criteria: 1. acute penetrating, puncture and burn wounds of the upper or lower extremity that meet the inclusion and exclusion criteria for the wound type: 1. penetrating, puncture or laceration wounds: stage ii-iii (partial to full thickness loss of dermis) excluding diabetic or venous wounds, and pressure ulcers and perforated wounds (except gunshot wounds) and wounds with exposed bones, facia or muscle. 2. gunshot wounds (gsw): grade i - ii on the red cross classification of war wounds6 (diameter of entry + exit wounds \< 10 cm, wound cavity or not, no fracture or fraction without clinically significant comminution). non-penetrating, penetrating, or perforated gsw are included. gsw with suspected vascular injuries or nerve damage are excluded. 3. burns: partial thickness injury ≤ 9% tbsa. thermal burn from flame or scald, chemical burns, and electrical burn are included. radiation and frostbite burns are excluded. 2. males and females ≥18 years old. 3. has access to a computer or mobile device for telepresence visits. 4. able to give informed consent and willing to comply with all required study procedures. exclusion criteria: 1. any wound likely to require irrigation and debridement in an operating room (or) setting. 2. concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, traumatic brain injury, other serious or unstabilized organ damage from trauma, etc.). 3. \> 72 hrs from initial injury. 4. pregnant or lactating females. 5. patients with known allergy(ies) to any of the components of the study irrigation system. 6. patients who are considered by the investigator for any reason to be an unsuitable candidate.
a registry for patients with systemic mastocytosis in china

Conditions: Systemic Mastocytoses

Summary: the registry for patients with systemic mastocytosis in china is a voluntary, observational database that will capture demographic, socioeconomic, and disease information with systemic mastocytosis. no experimental intervention is involved.

systemic mastocytosis (sm) is an extremely rare and heterogeneous spectrum of diseases characterized by the buildup of genetically altered mast cells in bone marrow sections and/or other extracutaneous organ(s). sm has not been given enough attention in china at present, and the epidemiological data in china are not clear. to understand the epidemiological characteristics and distribution patterns of sm patients in china. to establish a china-wide database platform for registering sm patients and to develop uniform registration standards and processes; to register sm patients who meet the enrollment criteria nationwide through a multicenter collaborative approach and to collect information on their baseline data, clinical manifestations, laboratory tests, treatment regimens, and follow-up results; to perform quality control and data cleansing on the information collected in the registration database, as well as to perform descriptive and inferential statistical analyses.

Eligibility criteria:
inclusion criteria: 1. any patient with a diagnosis of systemic mastocytosis according to world health organization (who) classification, including subtypes of sm, who is willing and able to provide written online informed consent. exclusion criteria: none
additional chemotherapy after neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: the aim of this study is to evaluate the efficacy and safety of additional neoadjuvant chemotherapy with capecitabine during the resting periods in patients with locally advanced rectal cancer.

neoadjuvant chemoradiotherapy (ncrt) has been used as standard treatment modality in patients with locally advanced rectal cancer (larc) because of increased local control, enhanced sphincter preservation, and less toxicity.ncrt has enhanced down-staging of tumor and reduced local recurrence. however, survival benefit of ncrt has not been demonstrated and the rate of distant metastasis was still reported as high as 30%. patients with pathologic complete remission (pcr) after ncrt have shown excellent survival benefit. we inferred that additional chemotherapy during the resting period could enhance the pcr rate. the aim of the present study is to evaluate the safety and efficacy of an additional 4-week chemotherapy with capecitabine after the conventional 6-week ncrt in patients with larc.

Eligibility criteria:
inclusion criteria: * histologically proven, locally advanced adenocarcinoma of the rectum * an eastern cooperative oncology group (ecog) score of 0-2 * adequate function of major organs * a signed informed consent. exclusion criteria: * other co-existing malignancy or malignancy within the last 5 years prior to enrollment * severe concurrent medical or psychiatric disorders * prior rt to pelvis * pregnant or lactating patients

Keywords: rectal cancer neoadjuvant chemoradiotherapy capecitabine
surgery in chronic cough gerd related

Conditions: GERD

Summary: the effectiveness of surgical fundoplication in treating classical reflux symptoms is well documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly secondary to gastro-esophageal reflux disease (gord) is far to be assessed. the effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15% to 95%; the spread of these data is largely attributable to disparate study design and methodology, patient selection, and outcome metrics. in order to assess whether anti-reflux surgery may have beneficial effects on chronic cough allegedly secondary to gerd and to eventually identify the preoperative clinical profile which could predict those positive effects, we considered two groups of patients presenting with 1) gerd associated to chronic cough, 2), typical gerd who underwent anti-reflux surgery.

pre-operatively, patients routinely underwent the symptoms assessment, barium swallow, upper gastro-intestinal endoscopy and esophageal manometry. the type and severity of symptoms and the grade of reflux oesophagitis were scored using a questionnaire with semi-quantitative scales. the upper gastro-intestinal (gi) endoscopy, barium swallow and esophageal manometry were performed according to standard techniques; reflux esophagitis was reported according to the los angeles classification. in the absence of los angeles grade a or higher esophagitis, patient underwent a 24h ph-recording or intraluminal impedance/ph monitoring. patients complaining of chronic cough were submitted to a specific work-up consisting of a chest high resolution computed tomography (hrct) scan, methacholine challenge test and spirometry in order to exclude pulmonary diseases. surgery was performed in patients negative for pulmonary diseases on chest hrct scan, on methacholine challenge test and spirometry, in consideration of the fact that patients had been referred mainly for the therapy of chronic cough. the study was started in 1995 and it was closed in 2010.

Eligibility criteria:
inclusion criteria: patients aged \> 18 years, affected by chronic cough (\> 8 weeks)associated with gerd typical symptoms, negative for pulmonary diseases on chest hrct scan, on methacholine challenge test and spirometry, undergoing anti-reflux surgery exclusion criteria: patients with chronic cough (\> 8 weeks) positive for pulmonary diseases on chest high resolution computed tomography (hrct) scan, methacholine challenge test and spirometry; association of gerd with epiphrenic esophageal diverticulum, collagen diseases, undetermined esophageal motility disorders, redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and stomach,on the diaphragm.

Keywords: chronic cough esophagus gastro-esophageal reflux disease esophageal surgery minimally invasive surgery extra-esophageal reflux symptoms.
breastmilk in response to a bout of exercise

Conditions: Infant Development; Obesity, Childhood; Diabetes, Childhood-Onset

Summary: the purpose of this study is to unveil the mechanistic benefits of a bout of postpartum maternal exercise on infant health that are provided by breastmilk.

the nutrients and antibodies in breastmilk promote infant growth, development, and immunity. breastfed infants exhibit lower risk of adult-onset obesity and type 2 diabetes compared to formula-fed infants, and the composition of breastmilk is influenced by maternal factors such as obesity and type 2 diabetes, profoundly impacting its health benefits. while postpartum maternal exercise enhances infant health, its effects on breastmilk composition remain unknown, hindering our understanding of how postpartum exercise benefits breastfed infants.

Eligibility criteria:
exclusion criteria: * active coronary artery disease or heart failure. * participation in a structured exercise program ≥ 1 day/week in the "inactive" subcohort or \< 3 days per week in the "active" subcohort. * a known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: * abnormal liver function test results (transaminase \>2 times the upper limit of normal * abnormal renal function test results (calculated gfr \<60 ml/min/1.73m2); * if on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study * uncontrolled thyroid disease (tsh undetectable or \>10 mlu/l); testing required within three months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise * abuse of alcohol or recreational drugs * active tobacco smoking within the past 3 months * infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis). * uncontrolled arterial hypertension (resting diastolic blood pressure \>90 mmhg and/or systolic blood pressure \>160 mmhg) at the time of screening. * a recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol * active pregnancy * restrictions on use of other drugs or treatments: * any other medication believed to be a contraindication to the subject's participation.

Keywords: breast milk postpartum exercise
transcutaneous auricular vagus nerve stimulation device in ckd population

Conditions: Chronic Kidney Disease

Summary: the purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (tavns) device in patients with chronic kidney disease (ckd). this data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of ckd. the primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. the pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (cv) mortality in the ckd population.


Eligibility criteria:
inclusion criteria: • individual 18-80 years of age with ckd stage 3-5 (egfr \<60 ml/min/1.73m2) on most recent outpatient labs. exclusion criteria: * pacemaker dependent * prisoners * pregnant women. a pregnancy test will be offered if a subject is concerned about being pregnant. * not capable of informed consent * know autonomic function disorder (e.g. parkinson's disease with autonomic dysfunction) * icd or ppm precluding assessment of heart rate variability (e.g. chronic atrial fibrillation) * recent myocardial infarction (4 weeks or less) * maintenance dialysis * epilepsy * patients on labetalol (labetalol will interfere with catecholamine measurements) * patients with diabetes * at least 50% of cohort must not be on beta blockers. this will help to distinguish the confounding effects of beta blockers.