Kornimate/medical-research-clean huggingface dataset:
neoadjuvant immunoradiotherapy with evorpacept and pembrolizumab in hpvopc (human papilloma virus oropharynx cancer)

Conditions: Oropharynx Cancer

Summary: the majority of head and neck cancer patients do not respond to immunotherapies, and clinical responses are often not durable. however, targeting tumors with stereotactic radiation in combination with immunotherapy while sparing draining lymphatics enhances anticancer immunity, resulting in dramatic response in hpv (human papilloma virus) virus related cancers of the throat. this trial will leverage targeted tumor radiation and immunotherapy in advance of standard surgical therapy to improve the response of hpv (human papilloma virus) throat cancer to radiation and immunotherapy.

this is a prospective, multi-center, open-label, one-arm, two-stage, phase ii study to evaluate the efficacy of neoadjuvant immunoradiotherapy (nirt) in patients with stage i hpvopc (human papilloma virus oropharynx cancer) amenable to surgical resection, including ajcc (american joint committee on cancer) viii t1-2n1m0 hpvopc (human papilloma virus oropharynx cancer) and excluding patients with solitary lymph nodes less than 3 cm. a simon's two-stage optimal design is used for this study. we will test the hypothesis that neoadjuvant stereotactic tumor targeting radiation along with cd47 inhibition (evorpacept) and pd-1 inhibition (pembrolizumab) provides pathologic response compared to current standard of care rates of locoregional control.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of stage i t1-2n1m0 hpvopc (human papilloma virus oropharynx cancer) * amenable to surgical resection * are able to safely receive neoadjuvant radiation and evorpacept/pembrolizumab exclusion criteria: • patients with solitary lymph nodes less than 3 cm
wise mind: environmental approach for obesity prevention

Conditions: Healthy

Summary: the study will be conducted in four catholic schools with children enrolled in grades 2 through 6. girls and boys and children of all racial types are eligible for participation in the study. we anticipate that approximately 1,000 to 1200 children will volunteer for the study. we request enrollment of 1200 children. to participate, parents must grant written consent and the child must assent by signing a consent form that is attached. two of the four schools that volunteer for participation in the study and are approved by the research team, will be randomly assigned to a health promotion program called "wise mind for diet and physical activity. the other two schools will be randomly assigned to a program called "wise mind for avoidance of alcohol, drugs, and tobacco." students will receive the program in the school that they attend. they will not be allowed to select one of the programs and will receive only one program, i.e., the program in their school. both health promotion programs will last for two academic years. each year, every child that is a research participant will be tested on two occasions, once during the first two months of school (sept and oct), and once during the last two months of school (march and april). testing will not be conducted during may in order to avoid interference with school activities at the end of the academic year. all children (in all four schools) will have the same testing. the testing will involve confidential measurement of eating habits, food intake, physical activity habits, attitudes about alcohol, drugs, and tobacco, body weight and height, body fatness, body image, mood, and self-esteem. the measurement techniques that will be used for this measurement will include: questionnaires, weighing, measurement of height, and photography of foods before and after eating. all measurements will be confidential and will not be released to anyone that is not involved in the management of the study, including school personnel. the total time requirement for each testing period is expected to be approximately three hours, spread over four testing periods during a two-week period. the testing periods will be conducted in conjunction with school administrators and will not be scheduled to conflict with important school activities, classes, or academic tests. a data and safety monitoring board (dsmb) will be organized to provide oversight for the conduct of the study.


Eligibility criteria:
* must be a student in one of the four catholic schools in baton rouge that have elected to participate in the study. * must be in the second through sixth grade at the start of the study.
fastframe knee spanning and damage control kit pmcf

Conditions: Fracture; Fractures, Bone; Fractures, Closed; Fractures, Open

Summary: the purpose of this prospective study is to confirm safety and performance of the fastframe external fixation system and corresponding instrumentation.

study title: fastframe™ external fixation system post-market clinical follow-up study (knee spanning kit and damage control kit) sponsor: zimmer biomet study design: prospective enrollment, prospective follow-up, single cohort study clinical phase: postmarket number of sites: up to three sites study duration per subject: subjects will be enrolled in the study until the time of exchange of their fastframe kit to another device. typically, this exchange occurs 2-4 weeks after injury. primary objective: the objective of this observational, prospective study is to confirm safety and performance of the fastframe external fixation system and corresponding instrumentation. primary endpoint: frequency and incidence of device-related adverse events and device deficiencies before the fastframe external fixation system is exchanged by another device (i.e. plates, screws, etc.). secondary endpoint: adverse events that occur between application of the fastframe external fixation system and exchange with another device that do not fall within the primary endpoint.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older * patient must be treated with either the knee spanning or damage control fastframe external fixation system according to the european economic area (eea) indications\* eea indications (a subset of the cleared us indications): the fastframe external fixation system - knee spanning kit is indicated for use in treatment of long bone (distal femur, proximal tibia) fractures. specifically, the system is intended for temporary stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated. the fastframe external fixation system - damage control kit is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. specifically, the system is intended for temporary stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated. exclusion criteria: * patient has an active or suspected infection * patient has conditions that limit their ability and/or willingness to follow instructions during the healing process * patient has inadequate skin, bone, or neurovascular status * patient is a prisoner * patient is pregnant and/or breastfeeding * patient is a known current alcohol and/or drug abuser in the opinion of the investigator * patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program in the opinion of the investigator

Keywords: external fixator, temporary stabilization
study of the cabochon system for improvement in the appearance of cellulite

Conditions: Gynoid Lipodystrophy

Summary: the purpose of this study is to evaluate the safety and effectiveness of the cabochon system for the improvement in the appearance of cellulite.


Eligibility criteria:
inclusion criteria: * female, age 18-55 * moderate or severe cellulite * bmi less than 35 * will not to try any other cellulite treatments through 12m follow-up exclusion criteria: * cellulite treatment on the thighs or buttocks in the last 90 days * prior liposuction in the thighs or buttocks * greater than 10% increase or decrease in body weight within past 6 months * evidence of active infection or a fever \>38c * current or recent smoker * history of hypertension, diabetes or hypoglycemia * history of coagulopathy(ies) and/or on anticoagulant medication * history of cardiopathy or pneumopathy * history of severe anemia * has atrophic scars, or has a history of atrophic scars or keloids * taken within 14 days of treatment: * nsaids (e.g. aspirin, ibuprofen, naproxen) * vitamin e, dietary supplements (e.g. gingko biloba, willow bark) * herbal teas * subject is pregnant or lactating for extended follow-up the following apply: inclusion criteria: * subject was enrolled and treated in the cp-01-1004 study - pivotal study of the cabochon system for improvement in the appearance of cellulite * subject understands and accepts the obligation not to try or receive any other cellulite treatments through 3 year follow-up exclusion criteria: * subject has undergone an injected drug, energy-based device, minimally-invasive or invasive procedure for contouring or cellulite on the buttocks or thighs since their 12 month study follow-up visit. * subject has used skin care products (e.g. creams) for improvement in cellulite within 1 month prior to the follow-up visit.
effect of ocrelizumab on cortical lesion accumulation in patients with ppms (oratorio-cortical)

Conditions: Primary Progressive Multiple Sclerosis

Summary: the goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.

to study the effect of ocrelizumab on cortical lesion accumulation in patients with primary-progressive multiple sclerosis participating in the oratorio: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study.

Eligibility criteria:
inclusion criteria: * patient participating in the oratorio study * mri scans available at baseline * presence of t2-weighted image (wi) (flair, t2/pd), and 2d/3d t1-wi at baseline exclusion criteria: - none
evaluation of the manifestation of patient aggresivity in an emergency department

Conditions: Emergency Room

Summary: the main objective of this study is to determine the average total number of violent events per observation period occurring in the emergency department at the nîmes university hospital. the list of violent events is pre-determined and based on a series of interviews with emergency department staff.

this observational study will take place via a representative sample of 90 observation periods. one observation period consists of 7.5 consecutive hours between two team rotations during the day and 10 consecutive hours at night. these observational periods include the moment when health-care teams are debriefed during a shift-change, which we suspect to be a sensitive time point. observation periods are randomly selected over a period of 1 year, and stratified for time of day (morning, afternoon, evening), day of the week and month. the secondary objectives of the observation phase are to identify factors associated with the average number of violent events per work period (number of patients attending the emergency department, time of staff debriefing during shift change, time of day, week or weekend, individual patient characteristics (gender, age, patient or accompanying a patient, waiting time from arrival in the emergency room to emergency consultation, reason for consultation), characteristics of victims of violence, characteristics of the health care team ...) the anticipated total number of violent events is unknown at the beginning of the study; we indicated '50' as a guess.

Eligibility criteria:
inclusion criteria: * persons manifesting violence according to a pre-determined list of watched-for events will be observed * the victims of the above-mentioned violence will also be observed and interviewed exclusion criteria: * persons not manifesting violence according to a pre-determined list of watched-for events

Keywords: violence
phase ii study of alendronate sodium in children with high-turnover idiopathic juvenile osteoporosis

Conditions: Osteoporosis

Summary: objectives: i. determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.

protocol outline: patients receive oral alendronate sodium weekly for 1 year. treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
eligibility criteria: * 5-14 years of age * weight 20 kg or greater * history of one or more atraumatic fracture * sexual development no greater than tanner ii * osteoporosis by dxa (diagnosis of high-turnover osteoporosis with no underlying cause (e.g., malignancy, hyperthyroidism, hyperparathyroidism, or vitamin d intoxication) inclusion criteria: * male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of \>20%). * bone mineral density by dxa at 2 standard deviations (sd) below normal mean for age (z-score at least 2 sd below normal mean at the lumbar spine or hip) * parental consent (and patient assent after age 12 years) to participate in the study. * sexual development at tanner stage ii or less (prepubertal stage) * weight 20kg and more exclusion criteria: * history of severe gastritis or reflux * marked kyphoscoliosis or inability to sit or stand for at least 30 minutes. * abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia) * hypersensitivity to bisphosphonates * uncorrected hypocalcemia * history of gastric or duodenal ulcers * renal dysfunction as indicated by serum creatinine greater than 1.5 mg/dl * liver dysfunction as indicated by serum sgpt greater than 2 times upper limit of normal for age or serum total bilirubin greater than 2.0 mg/dl * diagnosis of osteogenesis imperfecta (including family history) or blue sclerae or deafness * diagnosis of active rickets, osteomalacia, or bone alkaline phosphatase \> 2 times normal for age * severe gastritis or reflux * pregnancy * anorexia nervosa * prior/concurrent therapy- * prior course of prednisone allowed * no concurrent prednisone except inhaled steroids * no concurrent high-dose glucocorticoids * no concurrent salmon calcitonin * no other concurrent bisphosphonates * no concurrent long-term anti-seizure medication

Keywords: arthritis & connective tissue diseases idiopathic juvenile osteoporosis rare disease
the effect of levonorgestrel intrauterine system in preventing endometrial polyps recurrence

Conditions: Endometrial Polyp

Summary: the goal of this clinical trial is to determine whether the lng-ius is more effective to that of expectant in preventing endometrial polyp recurrence after hysteroscopic polypectomy. researchers will compare lng-ius to expectant management to see if lng-ius works to reduce the recurrence rate of endometrial polyps. participants will: receive mirena placement or not after hysteroscopic polypectomy； be scheduled for a follow-up with tvcd to screen for endometrial polyps recurrence every 6 months.


Eligibility criteria:
inclusion criteria: 1. （1）women age 20 to 48 years old; 2. （2）previous history of endometrial polypectomy; 3. （3）postoperative pathology confirmed endometrial polyps； 4. （4）women without fertility desire within 2 years； 5. （5）signed informed consent. exclusion criteria: 1. （1）contraindications for a hysteroscopic polypectomy or lng-ius or not willing to receive this type surgery； 2. （2）women who have a positive pregnancy test； 3. （3）a i and ii type submucosal uterine leiomyoma, congenital uterine malformation, atypical endometrial polyps, a (suspected) malignancy, atypical endometrial cells, reproductive tract infections； 4. （4）postoperative pathology confirmed non-endometrial polyps； 5. （5）postoperative pathology confirmed endometrial proliferative diseases which need hormone drug therapy after surgery； 6. （6）treatment with hormonal three months before surgery； 7. （7）the uterine cavity is more than 10 cm deep； 8. （8）women with severe diseases； 9. （9）women who were enrolled in another clinical study that could potentially impact the objectives of this study prior to their initial visit were excluded. 10. （10）unable to cooperate with the study procedures for various reasons, such as language comprehension difficulties, mental illness, inability to travel to the study center, or poor compliance.

Keywords: endometrial polyp levonorgestrel intrauterine system
bone microarchitectural database constitution from hr-pqct device in clinical situation potentially associated with bone loss

Conditions: Osteoporosis; Bone Loss

Summary: bone fracture occurrence is associated with an increasing of morbidity and mortality. some factors of fracture occurrence have been highlighted. for example, some diseases or therapy are known to increased risk of bone fracture only in some patients. accordingly, it is important for clinicians to identify patients at risk for bone fracture. right now, various tools are available for the clinicians: * clinical exam, * bone mineral density assessed by dual energy x-ray absorptiometry (dexa), * an algorithm based on interrogation, clinical exam and bone mineral density. however, prediction of bone fracture risk needs to be improved since only 50% of bone fractures can be predicted. dexa provides information for fracture risk estimation, but it is unable to distinguish cortical part to trabecular part. it also fails to quantify the microstructural properties that influence bone strength. bone microarchitecture, including the cortical compartment can now be assessed in vivo by the hr-pqct. this technique allows access to several parameters: on the one hand the volumetric bone mineral density for the whole area measured as well as cortical and trabecular regions, and on the other hand, the thickness and cortical porosity and the number of trabecular, their orientation and distribution. thus, the hr-pqct allows realizing a virtual bone biopsy and provides information on cortical and trabecular bone microarchitecture. this is the only noninvasive way to assess cortical and trabecular bone microarchitecture.


Eligibility criteria:
inclusion criteria: 1. for patients: 1.1.women or men taken in charge in saint-etienne' hospital and one of the following pathologies: 1.1-a : osteoporosis defined as: history of fracture by bone fragility documented 1.1-b : bone fragility: patient with the indication of bone densitometry without a fracture history 1.1-c articular inflammatory disease: rheumatoid arthritis, spondyloarthritis 1.1-d endocrine diseases : primary hyperparathyroidism, constitutional thinness, anorexia nervosa 1.2. written consent 2. for controls: 2.1. episode of acute back pain or radicular pain (lasting for less than a month) with taking corticosteroid less than 1 month 2.2. written consent exclusion criteria: drugs induced bone loss: 1.1.anti-aromasine or gnrh agonist for at least 6 months, 1.2. corticosteroid therapy 1.3. antiepileptic carbamazepine, phenobarbital, phenytoin, primidone, valproic acid for at least 6 months) 2. fracture due to bone fragility 3. drug with bone effect (bisphosphonate, teriparatide, strontium ranelate)

Keywords: fracture osteoporosis bone microarchitecture inflammatory joint diseases bone fragility rheumatoid arthritis spondyloarthritis primary hyperparathyroidism constitutional thinness anorexia nervosa
spanish version of the brief-bestest in stroke patients

Conditions: Stroke

Summary: the aim of this study is to adapt and validate the spanish version of the brief-bestest in stroke patients

balance disorder is a major risk factor for falls. the population that has suffered a cerebrovascular accident (cva) or stroke has balance disorders. over the last few years the assessment of balance has taken on special importance, carrying out the development, adaptation and validation of various tools that assess it. the brief-bestest has 6 items, it has demonstrated comparable reliability to the mini-bestest and potentially superior sensitivity. this version represents all dimensions based on the original bestest theory. the purpose is to adapt and validate the spanish version of the brief-bestest in stroke patients in order to have a brief tool, appropriate to the clinical environment and to the characteristics and limitations of these patients.

Eligibility criteria:
inclusion criteria: * older than 18 years old * diagnosis of stroke exclusion criteria: * cognitive impairment * physical disability that prevents them from completing the assessment * no cooperation and communication problems

Keywords: stroke validation study postural balance
apixaban for prophylaxis of thromboembolic outcomes in covid-19

Conditions: Covid19; Thrombosis

Summary: randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic covid-19 infection and risk factors for thrombosis.

randomized, double-blinded, placebo-controlled trial comparing oral anticoagulation with placebo for community-dwelling patients with symptomatic covid-19 infection and risk factors for thrombosis. randomization 1:1 - group 1 will receive apixaban 2.5mg twice daily vs. matching placebo (group 2) for 30 days. primary objective: to evaluate the clinical impact of a strategy of oral anticoagulation with apixaban comparing with placebo on the number of days alive and out of the hospital/emergency department (daoh) through 30 days in outpatients with symptomatic sars-cov2 infection and risk factors for thrombosis.

Eligibility criteria:
inclusion criteria: * outpatients with symptomatic laboratory-proven diagnosis of covid-19 (any exam that shows acute infection as positive pcr or igm in a context of acute symptoms ≤ 10 days) and * negative pregnancy test for women in child bearing period and * d-dimer level ≥ 2x uln or * c-reactive protein (crp) ≥ 10 mg/l or * at least two of the following risk factors: * d-dimer level ≥uln * crp ≥uln * age ≥65, * diabetes, * chronic kidney disease stage 3 * cardiopulmonary disease (for example, peripheral arterial disease, coronary artery disease, heart failure, chronic obstructive pulmonary disease), * history of pe/dvt, * nursing home/snf resident or severely restricted mobility * body mass index ≥30 kg/m2. exclusion criteria: * age \< 18 years-old * patients with indication for full anticoagulation during inclusion (for example, diagnosis of venous thromboembolism, atrial fibrillation, mechanical valve prosthesis) * platelets \< 50,000 /mm3 * use of acetylsalicylic acid \> 100 mg per day * use of p2y12 inhibitor (clopidogrel, prasugrel, ticagrelor) * chronic use of nsaids * hypersensitivity to apixaban * creatinine clearance \< 30 ml/min * pregnancy or breastfeeding * patients contraindicated to anticoagulation (active bleeding, recent major surgery, blood dyscrasia or prohibitive hemorrhage risk as evaluated by the investigator) * a history of hemorrhagic stroke or any intracranial bleeding at any time in the past or current intracranial neoplasm (benign or malignant), cerebral metastases, arteriovenous (av) malformation, or aneurysm * use of strong inhibitors of cytochrome p450 (cyp) 3a4 and/or p-glycoprotein (p-gp) (e.g. protease inhibitors, ketoconazole, itraconazole) and/or use of p-gp and strong cyp3a4 inducers (such as but not limited to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or st. john's wort)

Keywords: sars-cov2 anticoagulation apixaban