Kornimate/medical-research-clean huggingface dataset:
combination chemotherapy plus radiation therapy in treating children with newly diagnosed brain stem glioma

Conditions: Brain Tumors; Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining more than one drug with radiation therapy may kill more tumor cells. purpose: phase i trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma.

objectives: i. evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma. ii. assess the toxicity of this regimen in this patient population. outline: induction: patients receive oral etoposide daily on days 1-21 and vincristine iv on days 1, 8, and 15. treatment repeats every 4 weeks for 2 courses. patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy. maintenance: one week after induction therapy, patients receive vincristine iv on days 1 and 8 and oral etoposide daily on days 1-21. treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 30 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: newly diagnosed diffuse intrinsic brain stem glioma by mri at least 2/3 of the tumor in the pons tumor origin clearly in the pons at least 2 clinical features with less than 6 months duration: cranial nerve deficit long tract signs ataxia no diffuse brain stem enlargement secondary to neurofibromatosis no diffuse leptomeningeal disease patient characteristics: age: 3 to 21 performance status: karnofsky or lansky 50-100% life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 2.0 mg/dl alt no greater than 5 times upper limit of normal renal: creatinine or gfr normal for age prior concurrent therapy: biologic therapy: no prior biologic therapy chemotherapy: no other concurrent chemotherapy no prior chemotherapy endocrine therapy: prior glucocorticoids allowed radiotherapy: no prior radiotherapy surgery: no prior surgery other: no other concurrent investigational drugs

Keywords: untreated childhood brain stem glioma
evaluation of safety of hemoblast bellows in spine surgery

Conditions: Surgical Bleeding

Summary: the purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of hemoblast™ bellows. this study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.


Eligibility criteria:
inclusion criteria: * subject is undergoing open, elective, spine surgery * subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation * subject is 22 years of age or older * subject does not have an active or suspected infection at the surgical site * subject in whom the investigator is able to identify a target bleeding site (tbs) for which any applicable conventional means for hemostasis are ineffective or impractical * subject has a tbs with a surface bleeding severity scale (sbss) score of 1, 2, or 3 exclusion criteria: * subject is undergoing an emergency surgical procedure * subject is undergoing a laparoscopic surgery * subject is undergoing a cervical spine surgery * subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding * subject has a platelet count \ 1.5 within 4 weeks of surgery * subject receiving intravenous heparin within 12 hours before surgery or oral coumadin within 2 days before surgery * subject receiving antiplatelet medications within 5 days prior to surgery * subject receiving aspirin within 7 days prior to surgery * subject has an active or suspected infection at the surgical site * subject has had or has planned to receive any organ transplantation * subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent * subject has a known sensitivity or allergy to gadolinium * the subject has a contra-indication for mri or gadolinium contrast agent according to clinical guidelines, local regulations or manufacturer's recommendations * subject suffers from claustrophobia or fear of mri, or has any contraindication to mri (e.g., metal implants, spinal cord stimulator, etc. not suited to mri) * subject has american society of anesthesiologists classification of \> 4 * subject has a life expectancy of less than 3 months * subject has a documented severe congenital or acquired immunodeficiency * subject has religious or other objections to porcine, bovine, or human components * subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent * per investigator opinion subject is unable to fully cooperate with the study protocol. * the product will be placed in at the site where the dura is open * the product will be placed in the intradural or cranial space

Keywords: elective, spine surgery, bleeding control, hemostasis
comparison between myocardial tomoscintigraphies using a semiconductor camera or a conventional camera

Conditions: Myocardial Infarction; Ischemia

Summary: myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the presence and severity of abnormalities of myocardial perfusion, as well as the extension of infarction residua. however, actual imagery devices (gamma cameras) have low resolution and detection sensitivity. a new semiconductor camera has 8 to 10 time higher detection sensitivity and could allow proportionally diminishing injected activities or recording times. only one pilot study has been recently published on this type of camera, the d.spect camera. this study will compare images recorded during 15 to 20 minutes by conventional cameras and 2 to 4 minutes by d.spect camera in patients doing tomoscintigraphy under usual conditions. the purpose is to demonstrate the equivalence of images recorded by two camera types for diagnostic information and the secondary purpose is to demonstrate the superiority of the d.spect camera in terms of image quality.

this study will be conducted in nuclear medicine departments (nancy hospital, bichat hospital in paris, pasteur private hospital in toulouse), with d.spect camera (cyclopharma). the d.spect camera recording will be realized following the conventional camera recording and will not modify the routine programmed examination. recording times of d.spect camera will be maximum 2 minutes for imaging with a strong activity of technetium-99m labeled dye and maximum 4 minutes for imaging with thallium-201 or with a low activity of technetium-99m labeled dye.6 study groups will be analyzed: 4 groups of patients initially doing stress tomoscintigraphy with thallium-201 (group 1) or with technetium-99m labeled dye and then testing 3 principal injection sequences (group 2, 3, 4), and 2 groups of patients initially doing "myocardial viability" assessment with rest tomoscintigraphy with thallium-201 (group 5) or technetium-99m labeled dye. recording comparison obtained with 2 cameras will be done according to qualitative and quantitative criteria on image quality and analyzing diagnosis concordance (presence, type and severity of observed abnormalities).

Eligibility criteria:
inclusion criteria: * understanding and signature of informed consent * without any contraindication for tomoscintigraphy and stress techniques according to french society of cardiology and nuclear medicine criteria, as established for all patients doing this routine examination * not in emergency situation and with a stable clinical status (without any sign of heart or coronary failure, without uncontrolled high blood pressure under treatment) * having an effective contraception for women of childbearing potential exclusion criteria: * patient under guardianship
early mobilization in the icu

Conditions: Respiratory Failure

Summary: to study all icu patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

immediate mobilization of mechanically ventilated (mv) icu patients is not part of usual care in the u.s. or internationally. our previous work supports that early mobilization through physical and occupational therapy for icu patients on the ventilator can help them experience less delirium, spend less time in the icu and hospital, and become more independent when they leave. to advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific icu therapies may affect these outcomes.

Eligibility criteria:
inclusion criteria: * intubated and mv \> 24, \< 96 hours * baseline barthel index functional score \> 70, functional at home exclusion criteria: * rapidly changing neurological conditions (e.g. stroke) * cardiac arrest as cause for respiratory failure * elevated intracranial pressure * pregnancy (due to inability to provide continuous fetal monitoring) * terminal condition (life expectancy \< 6 months) * traumatic brain injury, multiple limb fractures, pelvic fractures, * severe chronic pain syndrome on admission

Keywords: mechanical ventilation physical therapy occupational therapy icu acquired weakness critical illness myopathy
scotoma reduction in amd patients treated with ranibizumab

Conditions: Macular Degeneration

Summary: this is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of lucentis.

patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of lucentis.

Eligibility criteria:
inclusion criteria: * bcva \< 20/320 * disciform macular degeneration wiht exudation exclusion criteria: * non-amd cnv

Keywords: amd disciform fibrosis lucentis scotoma
skin biopsy in the diagnosis of small fiber neuropathy in chinese patients with diabetes

Conditions: Small Fiber Neuropathy; Diabetic Neuropathies; Diabetes Mellitus

Summary: to detect small fiber neuropathy in patients with possible or established diabetic peripheral neuropathy (dpn) by skin biopsy and explore clinical characteristics and pathological features in chinese patients with diabetes.

small fiber neuropathy (sfn) is a subtype of diabetic neuropathy, patients with sfn often manifest as paresthesia of warmth, cold, pinprick and so on, especially affect ed length-dependent area. skin biopsy is an effective method to diagnose sfn with high diagnostic accuracy. the procedure is simple and minimally, and the wound usually heals within a few days. however, skin biopsy is not widely used in diagnose of sfn in chinese patients with diabetes. this study is aimed to establish a normal reference range of intraepidermal nerve fiber density (ienfd) in the chinese population, and to detect sfn in chinese patients with diabetes by skin biopsy.

Eligibility criteria:
inclusion criteria: * age ≧ 18 and ≦75 years old * a history of diabetes * symptoms of small fiber neuropathy such as pain, paresthesia, acanthesthesia after diagnosed with diabetes exclusion criteria: * acute skin infection or injury * coagulation disorders * history of malignant tumor * usage of neurotoxic drugs * alcohol abuse * vascular diseases, e.g. leaso and stroke * infectious diseases, e.g. hepatitis b, hiv, and syphilis * metabolic disorders, e.g. hypothyroidism, hyperlipidemia, and amyloid lesions * connective tissue diseases * nutritional disorders, e.g.vitamin b6 deficiency, and vitamin b12 deficiency * other causes of peripheral neuropathy, e.g. lumbar disc herniation, guillain-barre syndrome, and polyradiculopathy

Keywords: small fiber neuropathy diabetic neuropathies skin biopsy
a study to evaluate the safety of ozanimod exposure during pregnancy in women with ulcerative colitis and their infants

Conditions: Ulcerative Colitis

Summary: the purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (uc) who were exposed to ozanimod during pregnancy; the second is women with uc exposed to conventional therapy during pregnancy; the third is women with uc exposed to advanced therapy during pregnancy. this study will use data from a large us healthcare claims database.


Eligibility criteria:
inclusion criteria: * age 18 to 49 years on date of conception * date of conception between june 1, 2021 and september 1, 2030 * continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode * diagnosis of uc during the 12 months prior to conception through the end of the first trimester exclusion criteria: * • pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
autologous point-of-care adipose therapy: delayed injury/scar

Conditions: Burns; Contracture Scar; Surgical Injury

Summary: the goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. the main question it aims to answer are: - can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture? researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. participants will: * receive fat grafting at time of scar revision. * undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

soft-tissue injuries from blasts, burns, or multiple traumas can cause severe damage, leading to loss of function, lower quality of life, long recovery times, and inability to work. when these injuries involve deep burns or full-thickness tissue loss in areas that move a lot, they are especially difficult to treat due to the risk of scarring, stiffness, and tissue sticking together. there is a need for a reliable, single-stage treatment that can provide soft, flexible tissue reconstruction with minimal risk, cost, and, complexity. to address this issue, the investigators propose a fat-based approach to reconstruction. fat tissue is easily available from the patient's own body and carries many benefits in reconstructive surgery. our team has shown that using a layer of fat immediately in treatment creates a soft, vascular layer that reduces scarring, improves tissue volume, and supports a one-stage, multi-layer reconstruction without the need for complex surgery or causing harm to the donor area. the purpose of this study is to compare this reconstructive approach under the following conditions: • demonstrate non-inferiority of autologous layered composite grafting to full-thickness skin grafting for delayed reconstruction of post-burn/trauma scar contracture. evaluators including dedicated observers will be blinded to treatment group/strategy.

Eligibility criteria:
inclusion criteria: * the proposed study will include adult patients 18 years of age or older, * male or female, * civilian, military, active duty or retired veterans * presenting for scar contracture release and reconstruction at any level. * additional inclusion criteria includes willingness to be randomized to receive a fat graft. exclusion criteria: * age \< 18 years of age, * active infection, * medical co-morbidities or anatomic configuration deemed by the physician to be a concern for safety, * unwilling or unable to comply with study procedures, * radiation to the site of interest, * prisoners and/or vulnerable populations. * in addition, candidates that are pregnant or plan to become pregnant in the next year, will be excluded.

Keywords: burns scar contracture
manual lymph drainage

Conditions: Total Knee Arthroplasty; Post-operative Edema

Summary: manual lymphatic drainage (mld) is a specialized massage technique utilized to decrease various forms of edema. this technique promotes reuptake of interstitial fluid along the pathways of the lymphatic system. this technique promotes healing, decrease swelling, and decrease pain.

manual lymphatic drainage (mld) is a specialized massage technique utilized to decrease various forms of edema. edema can limit function, range of motion (rom) and increase pain after surgery. studies have shown that decreasing edema can increase knee strength and functional performance on various standardized measures. mld has been shown to be effective in patients with hind foot operations and increases rom post total knee replacement (tkr) surgery. the aim of this study is to determine whether mld on a sample of patients with tkr will decrease edema, increase rom and decrease pain as compared to tkr patients who do not receive mld.

Eligibility criteria:
inclusion criteria: * s/p total knee replacement * primary diagnosis of osteoarthritis or degenerative joint disease * able to read and understand english to consent * acceptance of the study protocol procedure exclusion criteria: * active infection * tumor * metastatic or systemic malignancy * acute thrombus * history of pulmonary embolism * major cardiac pathology such has angina * heart attack or uncompensated congestive heart failure (chf) * body mass index (bmi) \> 40 * pregnant or lactating women * renal dysfunction * joint revision * hospitalization length of stay less than or greater than 3 days * previous knee replacement * bilateral knee replacement
detection of sinusoidal obstruction syndrome with ultrasound after allogeneic hsct

Conditions: Sinusoidal Obstruction Syndrome

Summary: we would like conduct a retrospective study in our center to evaluate the early detection of sinusoidal obstruction syndrome with hepatic ultrasound after allogeneic hematopoietic stem cell transplantation.

the diagnosis of sinusoidal obstruction syndrome also know as veno-occlusive disease is often difficult. this is a potentially life-threatening complication that can develop after allogeneic hematopoietic stem cell transplantation. clinically, sinusoidal obstruction syndrome is charaterized by hepatomegaly, right upper quadrant pain, jaundice and ascites. the diagnosis is based on biological parameters (bilirubin increase ≥ 2mg/dl or 34.2µmol/l) and clinical evaluation (sodium fluid retention with weight gain \> 5%, ascites, painful hepatomegaly) (reference : m. mohty and al. revised criteria for sinusoidal obstruction syndrome, bone marrow transplantation (2016) 906-912). early therapeutic intervention is pivotal for survival in sinusoidal obstruction syndrome, thus a rapid and reliable diagnosis has to be made. to rule out major differential diagnosis, a reliable imaging method is needed. in practice, doppler ultrasonography, is helpful to detect hepatomegaly and ascites but also is an help to explore well defined criteria of sinusoidal obstruction syndrome already published. for sonography criteria: hepatomegaly (3 measures) with an increase of 2cm versus baseline, gallbladder wall thickening, ascites or 3 criteria of a native vod; splenomegaly, increase of the portal vein diameter, decrease of the hepatic vein diameter, visualisation of the para umbilical vein and for the doppler : increase of the hepatic artery ri (\>0.75), monophasic flow in the hepatic veins (venous retraction is very typical but very late), flow demodulation on portal vein, decrease in portal flow, portal flow congestion, reversed flow, flow recorded in the para-umbilical vein ; all five last signs are late (reference : lassau n. et al prognostic value of doppler ultrasonography in hepatic veno occlusive disease. transplantation 2002 jul 15 ;74(1) :60-6). these criteria can confirm the diagnosis : 6 signs of wich the first 3 can affirm the diagnosis with certainty in combination with clinical and biological parameters. there is currently a few data in the literature about early detection of this complication with systematic ultrasound. in this study, we want to evaluate in a retrospective study the interest of this technique in the early and systematic detection of sinusoidal obstruction syndrome.

Eligibility criteria:
inclusion criteria: * all adult patients with allogeneic hematopoietic stem cell transplantation in nancy university hospital between sep 2016 and sep 2018 exclusion criteria: * age \< 18 years old

Keywords: sos
endovascular treatment for acute ischemic stroke in china

Conditions: Stroke; Endovascular Treatment

Summary: this is a retrospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a chinese population.


Eligibility criteria:
inclusion criteria: * age: ≥ 18; * ischemic stroke confirmed by head ct or mri; * patients receiving endovascular treatment; * first ever stroke or mrs≤2 after previous disease; * complete and clear pre- and post-operative dsa images are available exclusion criteria: * imaging data not qualified for evaluation; * absence of important clinical data; * the first 50 patients receiving endovascular treatment in a single centerr.