Kornimate/medical-research-clean huggingface dataset:
glucose-stimulated pancreatic islet and intestinal blood flow in healthy subjects and in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: type 1 diabetes is the major type of diabetes in the young. the pathophysiology still needs clarification in order to reach feasible means of preventing the disease. this study aims in defining the differences in pancreatic and intestinal blood flow between subjects with and without type 1 diabetes and validating the methodology to achieve this. earlier animal studies have demonstrated changes in pancreatic islet blood flow using microspheres. the aim of this study is to test and validate a method for the assessment of islet perfusion in humans using molecular imaging. the investigators hypothesize that glucose-stimulated pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this increase is mostly suppressed in subjects with type 1 diabetes. positron emission tomography (pet) is a non-invasive imaging technique, which can be used to study flow and metabolism of different organs. using radiowater (\[15o\]h2o) and pet, cellular perfusion can be measured directly and noninvasively. recently, diffusion weighted magnetic resonance imaging (dwi) has also been applied as a complimentary method for the assessment to quantitate changes in pancreatic blood flow. in the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two separate days. pancreatic and intestinal perfusion are first measured with \[15o\]h2o and combined pet/magnetic resonance imaging before and 5 and 15 minutes after intravenous glucose infusion. on the second day, pet imaging is replaced by dynamic dwi conducted in the same time schedule and with intravenous glucose stimulation.


Eligibility criteria:
criteria for healthy subjects inclusion criteria * healthy as judged by history and examination * age 18-30 years * body mass index (bmi) 18 - 27 kg/m2 * normal 2 h oral glucose tolerance test exclusion criteria * any chronic disease * pregnancy * blood pressure \> 140/90 mmhg * smoking * presence of any ferromagnetic objects in the body * any other condition that could possibly create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of the study results criteria for subjects with type 1 diabetes (t1d) inclusion criteria * t1d diagnosed at least 5 years ago * age 18-30 years * bmi 18 - 30 kg/m2 * good or moderate glycemic control with long-acting insulin analogue combined with injections of rapid-acting insulin * uncomplicated t1d or with minor microvascular complications exclusion criteria * any other condition or disease possibly affecting circulation, as evaluated by a physician * pregnancy * blood pressure \> 140/90 mmhg * smoking * presence of any ferromagnetic objects in the body * any other condition that could possibly create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of the study results
lymphedema after urologic surgery

Conditions: Urinary Bladder Neoplasms; Prostatic Neoplasms; Testicular Neoplasms; Penile Cancer

Summary: lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. however, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. this project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the lymphedema quality of life questionnaire (lymqol), delfin moisturemeter d, and lower limb volume measurements.


Eligibility criteria:
inclusion criteria: * patients undergoing urologic surgery with lymph node dissection exclusion criteria: * none

Keywords: lymphedema lymph node excision
prevalence of gastroesophageal reflux during childhood and teenage years in france

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to assess prevalence of gastrooesophageal reflux during childhood and teenage years in france and to describe patients'symptoms and gastrooesophageal reflux management


Eligibility criteria:
inclusion criteria: * children from 0 to 17years old seen in consultation exclusion criteria:

Keywords: gastroesophageal reflux prevalence childhood france
a study of infliximab in patients with sarcoidosis

Conditions: Sarcoidosis

Summary: the purpose of this study is to evaluate the safety and effectiveness of infliximab (remicade) in patients with chronic sarcoidosis. infliximab (remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

the purpose of this study is to evaluate the safety and effectiveness of infliximab in the treatment of subjects with sarcoidosis with pulmonary involvement who show symptoms of the disease even though they are currently being treated with medication. patients will receive either placebo, 3 mg/kg infliximab, or 5 mg/kg infliximab infusions at weeks 0, 2, 6, 12, 18, and 24. safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. patients will receive infusions of infliximab (remicade) 3 or 5 mg/kg or placebo at weeks 0, 2, 6, 12, 18 and 24.

Eligibility criteria:
inclusion criteria: * patients must have been diagnosed with sarcoidosis at least 1 year prior to entry into the study * patients must have laboratory test diagnosing sarcoidosis prior to screening * patients must have a diagnosis of sarcoidosis by chest x- ray exclusion criteria: * patients must not have used any investigational drug within 1 month prior to entering the study * patients must not have received previous administration of a treatment with any other therapeutic agent targeted at reducing tnf such as pentoxifylline, thalidomide, etanercept, cdp 870, adalimumab, within 3 months prior to screening * patients must not have received vaccinations within 3 months

Keywords: sarcoidosis infliximab pulmonary involvement remicade
sinusoidal obstruction syndrome for stem cell transplant patients biomarker study

Conditions: Sinusoidal Obstruction Syndrome

Summary: the goal of this is to learn more about stem cell transplant and complications that some people have after their transplants, in particular sinusoidal obstruction syndrome (sos), also called veno-occlusive disease of the liver.

this is a multicenter, prospective, observational trial. we will measure biomarkers and determine thresholds that will predict increased risk for sos in pediatric patients receiving hct or high intensity chemotherapy/irradiation with the future goal of a randomized, interventional, open-label, multicenter trial that will test the preemptive use of defibrotide for prevention of sos in an enriched high-risk population.

Eligibility criteria:
inclusion criteria: age ≤ 25 years undergoing hct for any reason who fulfill any one (1) of the following criteria: 1. history of hepatic disease as defined by: 1. viral hepatitis (i.e., hepatitis c virus \[hcv\]) 2. liver tumor before hct 3. hepatic fibrosis or cirrhosis before hct as proven by liver biopsy 4. high aspartate aminotransferase (ast) (\> 2x uln) before hct (pre-transplant evaluation) 5. high alanine transaminase (alt) (\> 2x uln) before hct 6. high bilirubin (\> 1.2x uln) before hct 2. hct high-risk features including: a. conditioning with high-risk modalities including: i. busulfan (bu)-containing regimen particularly with oral bu + cyclophosphamide ii. tbi-containing regimen, particularly cyclophosphamide + total-body irradiation (tbi) b. ≥ 2 hct c. allo-hct for leukemia \> or = second relapse d. unrelated donor (urd) hct e. human leukocyte antigen (hla) mismatch hct (less than 10 of 10 for bone marrow/peripheral blood stem cell \[bm/pbsc\] or anything less than 6 of 6 for ucb) f. use of sirolimus + tacrolimus prophylaxis for gvhd 3. high-risk disease states including: 1. juvenile myelo-monocytic chronic leukemia (jmml) 2. primary hemophagocytic lymphohistiocytosis (hlh) 3. adrenoleukodystrophy 4. osteopetrosis 4. other high-risk features including: 1. prior treatment with gemtuzumab ozogamicin 2. use of hepatotoxic drugs 1 month before hct and during hct 3. iron overload (i.e., thalassemia/sickle cell) with serum ferritin \> 1000ng/ml 4. deficit of atiii, t-pa (i.e., \< 30% normal values), and resistance to activated protein c if clinical indication (these values do not have to be specifically checked if no clinical history) 5. young age \< 2 years but more than 1 month exclusion criteria: patients who are transplanted but do not fulfill any of the above mentioned criteria.
the effect of alpha-tocopherol in hemolysis and oxidative stress marker on the red cell membrane beta-thalassemia major

Conditions: Beta Thalassemia Major Anemia; Hemolysis; Oxidative Stress

Summary: the accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. multiple blood transfusions and iron overload cause cellular oxidative damage. however, α-tocopherol, an antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia major patient. by this randomized controlled trial, the investigators would like to evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major.

background: the accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. multiple blood transfusions and iron overload cause cellular oxidative damage. however, α-tocopherol, an antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia major patients. purpose: to evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major. methods: in this randomized controlled trial, the investigators allocated subjects in the placebo and α-tocopherol groups. doses of α-tocopherol were based on the recommendation of institute of medicine: 4-8 years old 200 mg/day; 9-13 years old 400 mg/day; 14-18 years old 600 mg/day. hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4 weeks of consuming either α-tocopherol or placebo, performed prior to blood transfusions.

Eligibility criteria:
inclusion criteria: * received frequent transfusions, * iron chelation * aged 5 - 18-year-olds * with no other hematologic disorders * does not consume any other antioxidants or herbal supplements exclusion criteria: * the acute or chronic infection including hepatitis b or hepatitis c, * splenectomy * liver failure * abnormality level of lipid test

Keywords: haptoglobin hemopexin hemolysis malondialdehyde glutathione oxidative stress alpha-tocopherol
anesthesia induction in patients undergoing surgery for cervical myelopathy

Conditions: Spinal Cord Diseases

Summary: aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation.

background: fiberoptic intubation is the preferred method of intubation in patients with acute symptoms or signs of cervical myelopathy. this approach minimizes cervical spine movements to prevent new neurologic deficits or further neurologic injury, and is the safer method to secure the airways in patients with foreseen difficult intubation. in these patients anaesthesia induction is aimed to prevent cervical spine movements and to maintain hemodynamic stability. the most commonly reported technique for anaesthesia induction in patients with cervical myelopathy is based on local anaesthesia and propofol administration. aim of this trial is to compare propofol-based anaesthesia vs. sevoflurane-based anaesthesia induction in patients with cervical myelopathy receiving oral or nasal fiberoptic intubation. methods: this randomized controlled trial is designed to prove equivalence. a series of 116 patients aged between 18 and 75 years, with cervical myelopathy will be enrolled. in all patients topical anaesthesia will be accomplished before anaesthesia induction. patients will be randomly assigned to one of two anaesthesia induction strategies (sevoflurane + o2 + air or propofol + o2 + air). when loss of consciousness occurs (indicated by bispectral index values between 40 and 50), oral or nasal fiberoptic intubation will be performed. the hemodynamic effects of the anaesthesia induction strategies will be assessed measuring mean arterial pressure at 4 time points: before anaesthesia induction (t1: baseline), at the end of anaesthesia induction when an adequate sedation level, with bispectral index values 40-50, is achieved (t2: sedation steady state); immediately after placement of endotracheal tube (t3: intubation); five minute after tracheal intubation (t4: post-intubation). secondary end-points of the study include the incidence of apnoea during induction process, diagnosed as absence of carbon dioxide trace for more than 10 seconds, the incidence of induction complications, defined as presence of laryngospasm, coughing and patient movement, and intubation conditions, defined as cord opening. discussion: we present the development phase of this anaesthesiological trial. a total of 40 patients have been enrolled from april 2009.

Eligibility criteria:
inclusion criteria: * patient undergoing cervical spine surgery; * male or female; * aged 18-75 years. exclusion criteria: * severe cardiovascular pathology; * liver disease; * renal disease; * bmi \>35; * allergies to any anaesthetic drugs.
middle-ear reflex testing using wideband acoustic immittance

Conditions: Hearing Disorders

Summary: this project will assess the middle-ear muscle reflex using wideband acoustic immittance which is a valuable method for evaluating infants, children, and adults. the developments will facilitate clinical applications that include hearing screening and diagnostic evaluation of persons of all ages with normal hearing and with hearing loss.

measurement of middle-ear muscle reflexes (memr) constitutes an important component of the standard of care in auditory function assessment and diagnostic audiology. an important component of the middle-ear test battery involves characterizing neural function through the eighth nerve-brainstem pathway which is accomplished through measurement of the memr. the evaluation component of this project will involve testing of human subjects using wideband acoustic immittance in the evaluation of middle-ear muscle reflexes. subjects in this project will be infants, children and adults with normal hearing as well as with conductive, sensory, and neural hearing loss. all subjects will receive wideband acoustic immittance (wai) and middle-ear muscle reflex (memr) testing. baseline testing includes pure tone audiometry and otoacoustic emissions.

Eligibility criteria:
inclusion criteria: * normal hearing or hearing loss exclusion criteria: * none

Keywords: middle ear muscle reflex wideband acoustic immittance
"cohort study on a/h1n1 flu during pregnancy"

Conditions: Influenza; Pregnancy

Summary: the purpose of this study is to measure the incidence of a/h1n1 influenza infection in the mother and her child and to identify the determinants in pregnant women during pandemic period in three public maternities in paris, france.


Eligibility criteria:
inclusion criteria: * \> 18 years * pregnancy between 12 and 35 weeks of gestation, going in one of the following maternity cares: port royal, necker, saint vincent de paul * provides written informed consent * speaks and understands french * covered by french social security exclusion criteria: * not covered by french social security * previous h1n1 influenza (virologically documented)

Keywords: pandemic a/h1n1 pregnancy cohort vaccine influenza and pregnancy
a study of fluzoparib±apatinib versus placebo maintenance treatment in patients with advanced ovarian cancer following response on first-line platinum-based chemotherapy

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: this is a multicenter, randomized, blinded, 3-arm phase 3 study to evaluate the efficacy and safety of fluzoparib alone or with apatinib versus placebo, as maintenance treatment, in patients with stage iii or iv ovarian cancer. patients must have completed first-line platinum based regimen with complete response (cr) or partial response (pr). the study contains a safety lead-in phase in which the safety and tolerability of fluzoparib+apatinib will be assessed prior to the phase 3 portion of the study.


Eligibility criteria:
inclusion criteria: * （phase 3）histologically new diagnosed, advanced (figo stage iii or iv) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) * （phase 3）complete response (cr) or partial response (pr) achieved with front-line platinum-based chemotherapy regimen as determined by investigator * （phase 3）ability to be randomized ≤8 weeks after last dose of platinum * （saftey lead-in）received 2\~4 prior chemotherapy regimens. platimun sensitive relapsed; have at least one measurable disease as defined by recist v1.1. exclusion criteria: * prior treatment with a poly (adp-ribose) polymerase (parp) inhibitor or apatinib * patients who have received other study drug treatment within 4 weeks prior to the first administration(\< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs). * patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.
association between changes of gfap after surgery and postoperative delayed cognitive recovery

Conditions: Astrogliosis; Postoperative Cognitive Dysfunction; Postoperative Delirium

Summary: assessment of serum level of glial fibrillary acidic protein (gfap) before surgery (on the day of surgery), 24 hours after surgery and on 3 or 4 postoperative day. neuropsychological testing before surgery and on 3 or 4 day after surgery. investigation of relationship between changes of gfap and scores of neuropsychological tests.


Eligibility criteria:
inclusion criteria: * patients with different diseases, who require prolonged laparoscopy or open surgery * age more than 60 * asa i-iii * informed consent to participate in the study exclusion criteria: * asa iv-v * severe neurodegenerative or psychological diseases
substudy: interconnection of arterial tumor feeders through tumor sinusoid in hcc

Conditions: Hepatocellular Carcinoma

Summary: it is postulated that all arterial tumor feeders supplying a hcc tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.

selective catheterization of segmental or more peripheral arteries in the procedure of transarterial treatment could be crucial in making a significant difference in survival outcome (1). subsegmental chemoembolization (tace) leading to portal vein visualization is associated with a higher chance of complete response (2), and complete response is a robust predictor of better overall survival (3). selective tace might also help to preserve liver function because tace damages liver parenchyma and repeated tace could lead to deterioration in liver function (4). in a procedure of ultra-selective tace, each of the arterial tumor feeders is supposed to be catheterized for complete treatment of the whole tumor when there are multiple tumor feeders (5), it could be time consuming and technically challenging to achieve catheterize all the tumor feeders at a sub-subsegmental level when difficult arterial anatomy is encountered, even with the guidance of a automated tumor-feeders detection software (6). in the angioarchitecture of hcc, arterial tumor feeders lead to tumor sinusoid which is an interconnected network of vascular channel within the tumor substance (7). it is postulated that all arterial tumor feeders supplying a hcc tumor are interconnected with each other through the tumor sinusoid, such that when one of the feeders is catheterized for delivery of a liquid embolic agent, the whole tumor sinusoid will be embolized, if the arterial blood flow in all the other feeders are stopped temporarily to create a negative pressure gradient.

Eligibility criteria:
inclusion criteria child-pugh grade a, hcc diagnosed with typical arterial enhancement and portal washout patterns on contrast enhanced ct or mri, solitary tumor, hypervascularity, well-defined margin, size ≤7cm, at least two arterial tumor feeders on ct scan
shoulder dislocations treated with button plates and non-absorbable suture anchor

Conditions: Shoulder Dislocation

Summary: the purpose of this study is to conduct a comparative study through clinical trials to verify the safety and efficacy of the products in the experimental group for clinical use.

the product of this clinical validation is the fixed button plate system, which is used for the reconstruction of the coracoclavicular ligament in the treatment of recurrent shoulder dislocation. the clinical trial was conducted to verify the rationality of its structural design, the convenience of its operation, and the effectiveness and safety of its clinical use. this trial was conducted in a parallel controlled trial design, the patients were divided into test and control groups to evaluate the safety and efficacy of the product.

Eligibility criteria:
inclusion criteria: 1. a glenoid defect ≥10% 2. contact sport athletes with a glenoid defect \< 10% 3. failure after bankart repair. exclusion criteria: 1. epilepsy 2. multidirectional shoulder instability 3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps 4. follow-up was less than 2 years or incomplete follow-up data.

Keywords: button non-absorbable suture anchor
shift to everolimus (rad) kidney sparing study

Conditions: Kidney Dysfunction; Heart Transplantation

Summary: the purpose of this study is to verify if the combination of everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.


Eligibility criteria:
inclusion criteria: * heart transplant with 1 to 4 years of follow-up * gfr between 20 and 60 ml/min (calculated with colkoroft-gault formula) exclusion criteria: * acute rejection in the previous 6 months * contraindications to statin therapy * ongoing infection * ongoing heart failure * myocardial infarction or myocardial revascularization after transplant * malignancy

Keywords: kidney heart transplantation creatinine glomerular filtration rate