Kornimate/medical-research-clean huggingface dataset:
impact of bladder depletion on mesorectal movements during radiotherapy in rectal cancer

Conditions: Rectal Cancer

Summary: this trial is assessing how bladder filling variations and thus mesorectal movements are less when radiotherapy treatment is received with an empty bladder in rectal cancer

the purpose of this study is to show that the variations of bladder volume and mesorectal movements are less with empty versus filled bladder in rectal cancer. in this study, patient will be treated with 3d conformal radiotherapy (3d-crt) radiotherapy with a filled bladder condition, as per standard care, in supine position. a total dose of 45 or 50 gy in 25 fractions, 5 fractions per week is received. a chest, abdomen and pelvis imaging will be performed before treatment start. patients receive planning ct scan with filled bladder and then with empty bladder on the same day. only planning ct scan with filled bladder will be used patient treatment. during radiotherapy treatment, patient will receive cbcts with filled ans empty bladder on day 1 ; 2 and 3 on the first week and once a week after. multiple parameters will be assessed before treatment (using planning ct scan) and during radiotherapy treatment (cbcts) in empty ans filled bladder conditions : bladder volume, mesorectal movements. a dosimetric study will be performed in intensity-modulated radiotherapy (imrt) in empty and filled bladder conditions

Eligibility criteria:
inclusion criteria: * histologically confirmed rectal adenocarcinoma * t2 n+ or t3 any n, eligible for radiotherapy or neo-adjuvant radio-chemotherapy treatment in a long course of 25 fractions * performance status less or equal to 2 * male or female 18 years and older * creatinine clearance greater than or equal to 50ml/min * fertile patients must use effective contraception * written informed consent * patient must be affiliated to a social health insurance exclusion criteria: * previous treatment with pelvic radiotherapy * chronic inflammatory bowel disease in flare-up. * urinary catheterization, urinary diversion or cystectomy * hip prosthesis * history of prostatectomy, or hysterectomy * urinary incontinence \> 2 * pregnant or nursing patient * persons deprived of their liberty, as well as adults subject to a legal protection measure * impossibility to submit to the medical follow-up of this clinical trial for geographical, social or psychological reasons

Keywords: 3d conformal radiotherapy (3dcrt) intensity-modulated radiotherapy (imrt) bladder filling mesorectal movements filled bladder empty bladder cone-beam computerized tomography (cbct)
efficacy and safety of intravenous iron sucrose in patients with hip fracture to prevent perioperative anemia

Conditions: Hip Fracture; Surgical Intervention

Summary: the purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.

the main objective of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia. it will also determine whether intravenous iron sucrose administration improve outcomes as haemoglobin values, transfusional needs, postoperative complications, length of hospital stay and cost-effectiveness.

Eligibility criteria:
inclusion criteria: * age \>= 65 years old * with hip fracture or peritrochanteric fracture. * who needs surgical intervention. * and sign the informed consent form. exclusion criteria: * tumor pathological fracture. * two or more long bone fractures. * seric ferritin levels \> 300 ng/ml. * hypersensitivity to iron sucrose or any component of the formulation. * patients with allogeneic transfusion rejection. * patients with previous blood transfusion request (hb\< 8g/dl). * patients treated with hematopoietic growth factors. * patients with anticoagulant treatment, due to thromboembolic high risk disease. * asthma in treatment. * cirrhosis, acute hepatitis, or increased aminotransferases (\> 3 times the upper limit of normal). * advanced dementia (gds\>5) from the global deterioration scale.

Keywords: intravenous iron sucrose anemia transfusion
data visualization of kidney and prostate tumors using routine pre-operative imaging, 3d printed, and 3d virtual reality models

Conditions: Pleural Effusion

Summary: the purpose of this study is to determine whether adding new methods of data visualization to routine clinical care will improve (i) surgical planning and (ii) surgical outcomes in patients with kidney and prostate tumors.

this early phase i trial studies how well indwelling pleural catheters with doxycycline work compared to indwelling pleural catheters alone in treating participants with malignant pleural effusions. these types of catheters are commonly used to treat pleural effusions (build-up of fluid in the lungs). doxycycline is an antibiotic that is also used to treat pleural effusions. it is not yet known whether giving doxycycline with indwelling pleural catheters works better than indwelling pleural catheters alone in treating participants with cancerous pleural effusions.

Eligibility criteria:
inclusion criteria: * outpatients with mpe undergoing ipc placement * sufficient mental capacity to provide informed consent and answer short-form six-dimension health index (sf-6d) and borg score questions exclusion criteria: * patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax) * inability or unwillingness to give informed consent * inability to perform phone call and clinical follow-up at md anderson cancer center (mdacc) * pregnancy * previous intrapleural therapy for mpe on the same side * eastern cooperative oncology group (ecog) of 4 and life expectancy ≤ 2 weeks * doxycycline allergy * extensive loculations or hydropneumothorax or other contraindication to pleurodesis * chylous effusions associated with malignant disease
persona of central serous chorioretinopathy

Conditions: Personality Type

Summary: purpose: central serous retinopathy (cscr) is characterized by macular detachment due to thickened choroid mostly affecting young men under perceived stress. while most previous studies in cscr have been retrospective and have focused on a single facet of the patient's personality, the investigators conducted a prospective intercontinental controlled study to analyze the multifaceted personality profile in cscr. design: prospective interview. participants and controls: subjects with cscr consented to participate in a questionnaire. controls not having retinal disease were recruited from the same clinic. main outcome measures: the main parameters registered were presence of stress, daily number of cups caffeine intake, personality traits (type a; obsessive-compulsive; aggressive). methods: the interview consisted of a 60-item questionnaire. recruitment of participants was from january 2015 to february 2016. controls were matched for age, gender and race. statistical analyses were done using univariate and multivariate analysis.

central serous chorioretinopathy (cscr) characterized by serous macular detachment is the fourth most common retinal disease after age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. in a population-based retrospective cohort and case control study in olmsted county, minnesota, usa, kitzmann et al4 reported a mean age-adjusted incidence of 9.9 (95% confidence interval \[ci\] 7.4-12.4) per 100, 000 in men, and 1.7 (95% ci 0.7-2.7) in women. the mean age of onset of cscr appears between 41 and 45 years5. the disease affects various racial groups5-8 and occasionally can be familial9. the pathogenesis remains poorly understood and currently the exudation is thought to result from hyper-permeable choroid secondary to venous stasis, ischemia, or inflammation2. because of lack of proper animal models and lack of definite cure, clinical research has focused on risk factors such as stress, corticosteroid intake, and type a personality. different hospital-based studies yielded different risk factors. epidemiologic studies failed to ascertain many of these risk factors. due to different methodology (retrospective vs. prospective case-control studies; selection of controls; questionnaire vs. interview by physician assistant vs. interview by physician) and focus on single risk factors in the literature, the investigators designed a study that targets a vast number of known or potential risk factors in various collaborative centers and compare it to results reported in the literature.

Eligibility criteria:
inclusion criteria: * clinical evidence by fluorescein angiography and oct of cscr disease * willingness to undergo long interview * ability to sign an informed consent exclusion criteria: * severe systemic hypertension * eclampsia
occipital transcranial direct current stimulation in fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study is to investigate whether transcranial direct current stimulation is effective in the treatment of fibromyalgia related pain. the study provides a placebo arm and the design is a cross-over design.


Eligibility criteria:
inclusion criteria: * patients suffering from fibromyalgia, diagnosed according to the criteria of the acr-90, with exclusion of other pathologies mimicking the fms related symptoms by a m.d. of the department of physical medicine and rehabilitation (uza, belgium) * dutch speaking * stability of medication during the study exclusion criteria: * history of substance abuse, unless treated and in remission during 6 months * cardiac disease, implanted pace-maker or defibrillator * history of epileptic insults * severe organic comorbidity * psychiatric comorbidity with psychotic symptoms * pregnancy

Keywords: fibromyalgia neuromodulation transcranial direct current stimulation occipital
site of embryo transfer in intracytoplasmic sperm injection

Conditions: Infertility

Summary: the technique of embryo transfer is thought to affect the implantation and pregnancy rate .at present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound.

many authors claimed that an increase in implantation and pregnancy rates has been reported to occur when embryos are transferred to the central area of the uterine cavity but there are no studies about the implantation site after using this type of transfer.

Eligibility criteria:
inclusion criteria: * 1- avf uterus. 2- bmi less than 30 exclusion criteria: * 1- rvf uterus. 2- bmi more than 30.
impact of mode of anesthesia on ischemia modified albumin in patients with traumatic brain injury

Conditions: Oxidative Stress

Summary: in the current study the investigators intend to evaluate the mode of anesthesia on ischemia modified albumin and outcome in patients with traumatic brain injury undergoing emergency craniotomy

after obtaining institutional ethical committee approval and written informed consent from legally acceptable representative relatives, patients with traumatic brain injury, aged from 18- 60 years old, asa from (i-iii), gcs more than 8 undergoing emergency craniotomy surgery will be selected for this prospective randomized study. the anesthesia will be induced with 2mcg/kg fentanyl and 2 mg/kg propofol. muscle relaxation will be achieved with 0.5 mg/kg atracurium. anesthesia will be maintained with: * group i, isoflurane (mac\<1) mixed with oxygen 40% and fentanyl 1mcg/kg hourly. * group pd, propofol infusion(100-150mcg/kg/min) and dexmedetomedine 0.3mcg/kg /h. parameters will be assessed preoperative period * ischemia modified albumin level from venous sample. * basal systolic blood pressure, diastolic blood pressure. mean arterial blood pressure, oxygen saturation, heart rate. * gcs. intraoperative period * systolic blood pressure, diastolic blood pressure. mean arterial blood pressure, oxygen saturation, heart rate after intubation, 5,15,30,60,90min and after extubation. * need for resuscitation with vasoactive drugs. * brain relaxation score at dural opening and closure. * icp * intraoperative blood loss. * amount of fluid and blood transfusion. postoperative period * ischemia modified albumin immediately postoperatively, after 6h and after 24 hours. * type of surgery. * duration of surgery. * extubation time. * recovery scores (ramsay sedation score and modified alderte score). * gcs immediately postoperatively, after 6h, after 24h and after 48 hours. * total analgesic requirement during the first 24 hours. * need for icu admission. * length of icu stay. * complications. * 28 day mortality.

Eligibility criteria:
inclusion criteria: 1. age 18-60 years old of both sex . 2. isolated traumatic brain injury undergoing emergency craniotomy. 3. g.c.s more than 8. 4. asa grade (i-iii). exclusion criteria: 1. non traumatic brain injury. 2. poly trauma patient. 3. coagulation disorder. 4. drug( alcohol, opiods, tranquilizers) addiction. 5. liver and kidney dysfunction. 6. severe diseases such as severe hypertension, cardiovascular disease, malignant tumor, autoimmune disease, mental disorders. 7. diabetes mellitus with poor blood glucose control. 8. previous drug allergy. 9. currently lactating.

Keywords: ischemia modified albumin oxidative stress traumatic brain injury
changes in the upper airway volume after rapid maxillary expansion in adults using pure skeletal anchorage

Conditions: Orthodontic Appliance Complication; Dental Malocclusion; Bone Anchored Rapid Maxillary Expansion; Maxillary Hypoplasia; BAME

Summary: the objective of this study is to evaluate the effect of bone-anchored rapid maxillary expansion (rme) in the volume of the right maxillary sinus, left maxillary sinus and nasal and maxillary sinus airway complex, through bone anchored maxillary expansion devices (bame); in addition, the influence of gender and age in the volume changes will be also analyzed. material and method: 18 patients between undergone rme treatment with a jackscrew based on 4 miniscrews which will be placed in the palate on both sides of the midpalatal suture. cone-beam computed tomography (cbct) scans will be taken before and after suture palatine expansion and datasets will be uploaded into therapeutic digital planning software to measure the volume (mm3) of the right maxillary sinus, left maxillary sinus (mm3) and nasal and maxillary sinus airway complex (mm3). the airway volumes will be isolated after selecting the anatomical area in the axial, coronal and sagittal space plane and ensuring the air density measurement by reference points placement inside the selected area. statistical analysis between preoperative and postoperative measurements will be performed using the statistical analysis of the t-test.


Eligibility criteria:
inclusion criteria: * adult patients * no history of systemic conditions that could interfere in bone metabolism and in the surgical process of orthodontic mini-implant placement * radiographic imaging (cbct kavo op3d pro fov 13x15cm) of maxillary discrepancy of more than 3mm compared with the ideal dimensions according to their mandible exclusion criteria: * age more than 31 years old * systematic conditions that interfere in bone metabolism
the role of c-11 choline pet in patients with prostate cancer

Conditions: Latent Cancer Prostate

Summary: the investigators determine the target number as 54 patients based on the following reasons: (a) the bony metastasis rate for the high risk prostate cancer patients with psa from 20 to 99.9 ng/ml was 21% (166/767 cases in a systemic review) \[8\]; the estimated sample size would be 47 under the condition of 20% more distant metastasis cases were identified by the pet/mri scan using the 90% power, significance level of 0.05 and one sample proportion test. assuming a dropout rate of 10%, the final ideal sample size is 52 patients. (b) the newly diagnostic number for the high risk prostate cancer patients in our hospital annually is \~70, about 6 patients a month. it is clinically feasible to recruit 3 patients a month until 18 months since the study begin. the study could be completed in 2 years with 54 cases

\[11c\] choline positron emission tomography (pet) is an emerging modality for staging at initial diagnosis or re-staging at the time of treatment failure. the updated study shows 11c -labeled choline derivatives seem to be the most promising pet radionuclides in assessment of prostate cancer and usa fda approves the utility of c-11 choline in prostate cancer patients in 2012 september. to our best literature search, there are only few preliminary studies regarding application of pet/mr in prostate cancer patients and the initial results in correlation of functional mri and pet images seems promising. combined pet/mri images have the advantage of giving anatomical, functional, and metabolic information in a single image setting and provide a comprehensive survey including local regional extension and systemic metastasis. unlike in the usa where more than 70% prostate cancer patients were diagnosed at early stage, most prostate cancer patients in taiwan were diagnosed at advanced stage with high psa or t3-4 disease, or even systemic metastasis. the need to implement good staging modality is even more urgently needed in taiwan than in usa and related studies are still lacking. in the current study, our hypothesis is that c-11 choline pet/mri is a good modality in staging high risk prostate cancer patients, and in predicting patients' outcome after treatment. our hypothesis will be examined by this clinical study.

Eligibility criteria:
inclusion criteria: 1. clinically suspicious and/or pathology-proved high risk group prostate cancer patients (psa \> 20 ng/ml, or gleason score 8-10, or clinical stage \>t2c) 2. age equals or more than 20 years old 3. willing to sign the informed consent exclusion criteria: 1. patients with a concomitant or previous malignancy history 2. unable to tolerate mr or pet/ct scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears, hip prosthesis), claustrophobia, unable to lie still 3. unable to give informed consent 4. previous allergy to carbon-labelled radionuclide

Keywords: prostate cancer c11 choline pet/mr staging biochemical failure
expanded access protocol for an intermediate size population - ravicti for byler disease

Conditions: Byler Disease

Summary: byler disease is the result of a homozygous missense (g308v) mutation in the atp8b1 gene. the disease is typically manifest in the first year of life on the basis of complications of cholestasis; common presentations include jaundice, poor growth, bleeding related to vitamin k deficiency, and/or weak bones related to vitamin d deficiency. early management of byler disease is directed at nutritional issues which tend to be responsive to medical intervention, unlike the pruritus/scratching which remains a devastating problem. progressive liver disease develops in byler disease and can lead to cirrhosis and end-stage liver disease. this is an open label expanded access protocol of ravicti in children with byler disease. the primary hypothesis is that the administration of ravicti in these children is feasible, well tolerated and safe. it is also hypothesized that ravicti treatment leads to an improvement in biochemical markers of liver disease and it may ameliorates or prevents the development of scratching behavior as a manifestation of pruritus attributed to the liver disease.


Eligibility criteria:
inclusion criteria: * byler disease as identified by a homozygous mutation in atp8b1 predicted to yield a g308v missense mutation * total serum bile acid \> 100 µm * male or female subjects of age greater than 130 days to begin screening procedures * male or female subjects of age greater than 180 days to begin ravicti therapy * ability and willingness to adhere to all study protocols * access to intermittent phone contact * written informed consent exclusion criteria: * prior surgical interruption of the enterohepatic circulation (including but not limited to partial biliary diversion and/or ileal exclusion) * liver transplantation * other diagnosed concomitant liver disease * evidence of portal hypertension * platelet count \< 150,000 and * spleen palpable \> 2 cm below the costal margin, or * history of a clinical complication/feature c/w portal hypertension * esophageal or gastric varix or variceal hemorrhage * ascites * hepatic encephalopathy * coagulopathy (pt \> 15 seconds or inr \> 1.5) despite vitamin k therapy * alt \> 10 x uln * allergy/hypersensitivity to ravicti or 4-phenylbutyrate * severe concurrent illnesses, such as neurological, cardiovascular, pulmonary, metabolic, endocrine, and renal disorders, that would interfere with the conduct and results of the study * known diagnosis of human immunodeficiency virus (hiv) infection * cancer or history of cancer * any female who is pregnant or lactating or who is planning to become pregnant with 1 year of enrollment * any known history of alcohol or substance abuse
evaluation of the reproducibility of the automated measurement of the extent of ild on chest ct

Conditions: Interstitial Lung Disease

Summary: in interstitial lung disease (ild), the extent of ild on chest computed tomography (ct) is recognized as an important prognostic factor. automated tools are now available to quantify ild, but there is a lack of data on the reproducibility of this measurement and therefore its accuracy. therefore, the purpose of this study is to evaluate the variability of automated ild quantification on chest ct. reproducibility will be assessed by repeating chest ct scans and using different tools to measure the extent of disease.

in interstitial lung disease (ild), the extent of ild on chest computed tomography (ct) is recognized as an important prognostic factor. in recent years, several tools based on texture analysis or deep learning methods have been developed to provide rapid and accurate automated quantification of ild extent. an advantage of automated scoring methods is that they theoretically offer perfect repeatability of measurement. however, this is only true if the measurement is repeated on the same images. several parameters can alter the appearance of the lungs on scanner images, such as the degree of inspiration or the reconstruction kernel used to reconstruct the images. there is a lack of data on the reproducibility of the whole process of automated ild quantification and therefore its accuracy. therefore, the purpose of this study is to evaluate the variability of automated ild quantification on chest ct. reproducibility will be assessed by repeating chest ct scans and using different tools to measure the extent of disease in patients with ild from 2 institutions. chest ct will be repeated the same day. this will allow assessment of the variability of automated measurement of ild extent between 2 ct scans performed on the same day and when using different software. it will also allow to assess the variability of lung volume between the 2 ct scans and the effect of disease (idiopathic pulmonary fibrosis or connective tissue disease-related ild) on the reproducibility of ild quantification.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * known interstitial lung disease as part of idiopathic pulmonary fibrosis or connective tissue disease * followed in one of the participating hospitals * requiring a chest ct as part of a scheduled assessment * affiliated to a french national social security * informed consent exclusion criteria: * acute exacerbation of ild * pregnancy * inability to hold an apnea for 10 seconds * patients in the exclusion period after a previous research * need for additional procubitus or expiratory images

Keywords: lung diseases interstitial lung disease multidetector computed tomography deep learning