Kornimate/medical-research-clean huggingface dataset:
neoadjuvant radiation in locally advanced breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to determine whether neoadjuvant radiation therapy is effective in improving local-regional control and to explore predictors of response to treatment in inoperable breast cancer patients after 2-6 courses of neoadjuvant chemotherapy.

rationale: the optimal management of patients with locally advanced breast cancer(labc) remains unknown. it is currently accepted that the administration of radiation therapy prior to surgery might result in higher surgery rate or improvement of clinical outcomes. outline： this is a prospective phase ii study. the purpose is to evaluate the effectiveness of neoadjuvant radiotherapy in combination with chemotherapy. the primary objective in this study is to assess clinical outcomes of these patients. a secondary objective in this study is to identify biomarkers and imaging parameters that can be used as early predictors of treatment response in women with locally advanced breast cancer. fresh tumor tissue or fresh peripheral blood should be collected as the test sample and stored before treatment. ultrasound spectroscopy including shear wave elastography parameters should be done before and after treatment.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced breast carcinoma * inoperable with with 4-6 courses of prior chemotherapy * no contradiction of radiation or chemo-radiotherapy * patients should have the ability to understand and the willingness to sign a written informed consent document * signed informed consent must be obtained prior to any study specific procedures exclusion criteria: * other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast dcis * coagulation disorders * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia * serious underlying medical illness with life expectancy less than 2 years. * any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.

Keywords: breast cancer neoadjuvant radiotherapy biomarkers
changes in echogenicity and muscle stiffness in elastography after botulinum toxin injection a spastic muscle

Conditions: Stroke

Summary: muscle alterations and modifications passive biomechanical properties that occur on a spastic muscle contribute to functional disorders involved in spasticity. botulinum toxin (tb) a is the reference treatment of the focused spasticity, and muscle source structural and biomechanical changes, very little studied in humans, especially since it is not one possibility of easily and reliably paraclinical assessment injections consequences.


Eligibility criteria:
inclusion criteria: * a first stroke older than nine months (acute phase and subacute stroke). * hemiplegia cerebral vascular following this stroke. * hemiplegia with an overall motor deficit plegic lower limb muscle testing level less than or equal to 3 and associating a localized spasticity lower plegic member, on the plantar flexors, assessed by the upper ashworth scale or equal to 1 with an injection of botulinum toxin indication of the sural triceps. * written consent. exclusion criteria: * old stroke with motor impairment of the lower limb in the chronic stage. * concomitant muscle disease (eg myopathy, myositis ...). * patients who already received a botulinum toxin injection into the gastrocnemius muscles. * subjects with defibrillator

Keywords: stroke botulinum toxin muscle alterations
using chws or mailing self sampling home tests to increase cervical cancer screening in south florida

Conditions: Cervical Cancer

Summary: the study will test the significance of community health worker (chw) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. the study will enroll 700 participants in communities that lack access to medical care in south florida.


Eligibility criteria:
inclusion criteria: * women * haitian, hispanic, or african american * ages 30-65 years * report not having had a pap smear in the last three years live in the cities of miami/little haiti, hialeah or unincorporated southern miami-dade exclusion criteria: * women who report having had a hysterectomy * women who have a history of cervical cancer * women who plan to move outside of miami-dade county during the next six months * women who are enrolled in any other cancer prevention/outreach related study * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners

Keywords: screen self-sampler cervical, cancer women community health workers hispanic/ latinas haitian focus of study is cervical cancer
vitros immunodiagnostic products nt-probnp ii

Conditions: Heart Failure

Summary: amino terminal pro-brain natriuretic peptide (ntprobnp) is secreted in conditions of cardiac wall stress. ntprobnp levels are used in addition to clinical assessment to diagnose heart failure (hf). the purpose of this clinical study is to collect data to substantiate the use of the vitros nt-probnp ii assay.

a prospective clinical sample collection and nt-probnp testing will be conducted in two populations. patients presenting to the emergency department (ed) and patients presenting to outpatient centers will be approached for enrollment. clinical and laboratory data will be collected to demonstrate product performance compared to adjudicated clinical diagnosis. approximately 4300 evaluable subjects at geographically dispersed sites in the us will be enrolled in the study. sample collection and testing of clinical samples with the vitros nt-probnp ii assay will be performed under two separate protocols.

Eligibility criteria:
acute hf population (ed setting): inclusion criteria: * subjects must have suspicion of hf and acute symptoms at presentation. * subjects must be at least 22 years of age. * subjects must be willing and able to provide informed consent. exclusion criteria: * acute symptoms clearly not secondary to hf. * subjects with renal disease on dialysis. * subjects unable to comply with the study requirements. population with suspicion of hf (outpatient setting): inclusion criteria: * subjects must be at least 22 years of age. * subjects must be willing and able to provide informed consent. * subjects who present to outpatient centers with suspicion hf. exclusion criteria: * symptoms clearly not secondary to hf. * subjects with renal disease on dialysis. * subjects unable to comply with the study requirements. * subjects previously diagnosed with heart failure.

Keywords: nt-probnp
measurement of optic nerve sheath in traumatic raised intracranial pressure

Conditions: Traumatic Brain Injury

Summary: trauma patients are at risk for serious head trauma. the consequences of serious head trauma are often life altering. currently, the only method available to rapidly assess the severity of head injury and need for neurosurgical intervention is the ct scan. this time consuming test requires transportation of a potentially unstable patient to the ct scanner. the investigators goal in traumatic brain injury is to identify early those patients who may require neurosurgical intervention. brain swelling (elevated intracranial pressure) is transmitted to the eye and this can be measured with ultrasound. the investigators hypothesis is that this test will rule out significant elevations in intracranial pressure and perform as well as ct scan in doing this. the investigators study aims to demonstrate that ultrasound of the optic nerve is as good as ct scan in ruling out clinically significant elevations in pressure within the brain. after consent has been obtained, any trauma patient who has an indication to undergo ct scan of the brain will also undergo ultrasound of the eye. a radiologist will then review the ct scans to determine if signs of elevated intracranial pressure are present. the investigators hope to demonstrate that a bedside ultrasound performed in the trauma suite is reliable for ruling out the possibility of elevated intracranial pressure. \*\*update august 2009\*\* currently, deferred consent has been obtained from our reb allowing us to defer consent for this intervention of minimal risk. as well, reb has also approved phone consent in the interim.


Eligibility criteria:
inclusion criteria: * age greater or equal to 16 involved in blunt trauma. * patient is to undergo a ct of the head to evaluate suspected closed head injury * consent and ultrasound can be preformed within 1 hour before or after ct of the head exclusion criteria: * penetrating trauma to the head or significant ocular trauma * patients not expected to survive transfer out of the emergency room department * patient is too unstable to undergo a ct of the head or ultrasound of the optic nerve

Keywords: intracranial pressure intracranial hypertension ultrasound emergency traumatic brain injury ocular ultrasound
gt719 injection for recurrent/refractory antibody mediated systemic immune diseases

Conditions: Neurological Disorder

Summary: this study is an open-label, prospective, exploratory clinical trial that includes a dose escalation phase and a dose expansion phase, aimed at evaluating the safety, cell dynamics, and preliminary efficacy of gt719 cells in adult participants with recurrent/refractory antibody-mediated neurological immune disorders.


Eligibility criteria:
inclusion criteria: * voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol. * expected survival period\>12 weeks. * any previous systemic treatment must have undergone at least 4 weeks or 5 half lives (whichever is shorter) by the time the participant plans to receive the study treatment. exclusion criteria: * history of organ transplantation, splenectomy, and allogeneic or autologous stem cell transplantation. * history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy. * received systemic corticosteroids within 7 days prior to gt719 infusion, except for inhaled corticosteroids
evaluation of surgical positioning in arthroscopic shoulder stabilization

Conditions: Shoulder Dislocation

Summary: the purpose of this study is to prospectively determine whether intra-operative factors, complications and post-operative outcomes differ between beach chair and lateral decubitus surgical positioning for patients receiving arthroscopic shoulder stabilization (anterior or posterior) due to shoulder instability.


Eligibility criteria:
inclusion criteria: -any patient undergoing arthroscopic labral repair due to shoulder instability, with or without concomitant debridement. exclusion criteria: * revision stabilization surgery * no previous bankart repairs, labral repairs, capsulorrhaphy, or latarjet * multidirectional shoulder instability * concomitant rotator cuff repair, biceps tenodesis/tenotomy, hagl repair * isolated slap repair/labral repair in association with mechanism other than -instability (eg: overhead athletes) open procedures for instability
intervention in single thyroid nodule.

Conditions: Thyroid Nodule

Summary: thyroid nodules are common clinical problem. the incidence is 2-4 per 100,000 people per year, being more common in women and the elderly. thyroid nodule is a "discrete lesion within the thyroid gland that is radiologically distinct from the surrounding thyroid parenchyma. most thyroid nodules are asymptomatic, may present as neck swelling

thyroid nodular disease comprises of a wide range of disorders. benign forms such as colloid nodules,cysts and thyroiditis are more comman than benign follicular neoplasms and thyroid carcinomas. incidence of malignancy ranges from 10% to 30% in solitary thyroid nodule(stn).studies have shown that the occurrence of malignancy is higher in case of solitary thyroid nodule compared to multinodular goitres. preoperative evaluation of thyroid nodules is important in distinguishing between benign and malignant thyroid nodules and also in treatment to avoid unnecessary extensive surgery and its complications. fine needle aspiration biopsy (fnab) is the most common method of examining solitary thyroid nodules today.total thyroidectomy and lobectomy remain the main primary surgical interventions for single thyroid nodule. there is debat between total thyroidectomy and hemithyroidectomy for patients with single thyroid nodule. our study is for comparing between total thyroidectomy and hemi thyroidectomy in single thyroid nodule

Eligibility criteria:
inclusion criteria: 1. age from 20 to 60 years. 2. patients with single thyroid lesion 3. fit for surgery exclusion criteria: 1. patients with age less than 20 years and more than 60 years. 2. patients with multiple thyroid lesions. 3. patients with advanced and metastatic malignancy. 4. unfit for surgery
positive outcomes of the supplementation with lecithin-based delivery form of curcuma longa and of boswellia serrata in ibs

Conditions: Boswellia Serrata; Irritable Bowel Syndrome

Summary: small bowel dysbiosis (sbd), is a frequent finding in subjects with irritable bowel syndrome (ibs). the formula-tion in sunflower lecithin (phytosome) of curcuma longa and boswellia serrata demonstrated beneficial effects on intestinal microbiota. the aim of this study was to evaluate the effect of a lecithin-based delivery formulation of curcuma longa and of boswellia serrata extracts (cubo), on sbd in ibs subjects.


Eligibility criteria:
inclusion criteria: * age ranging from 18 to 70 years; * diagnosis of moderate ibs according to rome iv criteria; * dysbiosis of the small bowel, defined by increased urinary indican values with normal values of urinary skatole; * evidence of abdominal bloating and abdominal pain exclusion criteria: * normal values of urinary indican or increased values of urinary skatole ; * subjects who were already on a low fodmap diet (lfd) or other dietary prescription, such as lactose or gluten free diet in the last 6 months; * insulin-dependent diabetes or seafood, nuts or soy allergies ; * positive history of symptomatic diverticular disease, celiac disease, inflammatory bowel disease or microscopic colitis; * colonic or small bowel or gallbladder surgery ; * severe vomiting or bloody diarrhea ; * liver disease (defined as altered values of liver function tests) or severe renal disease (defined as serum creatinine \>1.5 mg/dl) or treatment with antibiotics, excluding those for topical use, within the last three months

Keywords: bloating dysbiosis boswellia serrata curcuma longa irritable bowel syndrome microbiota phytosome
ad01 follow up extension visit

Conditions: Alzheimer´s Disease

Summary: patients who were vaccinated with affitope ad01 during affiris001 will undergo a long-term follow-up period to get more information regarding the safety profile of affitope ad01.


Eligibility criteria:
inclusion criteria: * written informed consent signed and dated by the patient or the patient's legal representative and the caregiver. * patients having participated in affiris 001 and aff003 and having received ≥1 vaccination with affitope ad01 * availability of a partner/caregiver knowing the patient exclusion criteria: * patients having received no vaccination with affitope ad01 * history of questionable compliance to visit schedule

Keywords: ad01 follow-up extension
fitness and well-being of caregivers in the hauts-de-france region

Conditions: Healthy

Summary: the ageing of the population is accompanied by an increase in the frequency of chronic illnesses, leading to a rise in the number of caregivers. these caregivers do not have the time to look after their own health, and they are very often in a deteriorated mental state with no knowledge of their level of fitness. a deterioration in their fitness can be a source of the development of diseases induced by a sedentary lifestyle. on the other hand, patients with chronic respiratory disease can benefit from respiratory rehabilitation (rr), which includes outpatient or home-based physical activity. the literature has demonstrated an improvement in the mental state of caregivers following a rr carried out by their loved ones without taking an interest in their fitness. the aim of the study will be to establish 1. a representation of the level of fitness and mental state of caregivers; 2. to assess the presence/absence of benefits on fitness and mental state of caregivers depending on the form of rr: home versus outpatient where the caregiver is not integrated in this last form.

the literature reports more anxiety and depressive symptoms , a greater psychological and social burden and a poorer quality of life in caregivers than in their non-caregivers peers. knowing the fitness of caregivers, by means of an assessment of their abilities, would make it possible to define their profile, which should reflect an altered fitness linked to a state of ill-being. the results of these assessments would make it possible to establish a prevention policy, and following a rehabilitation programme for their patients, their health should improve. for caregivers who agree to take part in the study, their physical, mental and social health will be assessed. the total duration of the visit, including all the assessments, is estimated at 1h30. we expect the fitness and mental and social state of all the caregivers to deteriorate in line with the indicators available in the literature for people of the same age who are not carers. following care of the patients, we expect an improvement in fitness and mental state of the carers.

Eligibility criteria:
inclusion criteria: * be of legal age; * have a sick relative taking part in a rr program, either as an outpatient at the clinique de la mitterie or at home with formaction santé; * have the cognitive ability to understand the instructions for carrying out the physical tests and the questions for answering the questionnaires; * be able to read; * have no disability preventing them from carrying out the physical tests; * have given their written consent to take part in the research; * be willing to comply with all the research procedures and duration. exclusion criteria: * refusal to sign consent; * operation less than one month old; * presence of psychological or psychiatric disorders; * impossibility of receiving informed information; * impossibility of participating in the entire study; * contraindication to physical activity.

Keywords: caregivers fitness mental health chronic respiratory disease
preventing chronic depression and ptsd in stroke patients admitted to the neuroscience intensive care unit (nicu) and their family caregivers

Conditions: Neurological Disorder

Summary: the current study has the following objectives: 1. to determine additional stroke patient (sp) and stroke caregiver (sc) factors including their perceptions of the stroke experience, hospitalization, and how they cope with its challenges; identify additional appropriate points to intervene (maladaptive coping styles, unrealistic expectations, inappropriate prioritization, misinformation about illness, and self care), and assess sp and sc preferences for the structure, mode of delivery (including potential for phone, video or a combination of these) and timing of an intervention. 2. to develop, \[using the preliminary data and information from aim 1\], and test the feasibility and acceptability (primary outcomes) of a skills-based intervention for preventing chronic depression, anxiety, ptsd and decreased qol in dyads at risk.


Eligibility criteria:
eligible dyads (stroke patients and stroke caregivers) must meet the following inclusion criteria: * age 18 or older * english fluency and literacy * hospitalized with an acute stroke (hemorrhagic and ischemic) within the past 2 weeks (patient) or primary stroke caregiver of a stroke patient currently admitted with an acute stroke * stroke patient or stroke caregiver screens in for depression and/or ptsd one or more of the following exclusion criteria will render a stroke patient (only) ineligible: * stroke patients who cannot participate due to the severity of stroke, cognitive impairment and/or aphasia, and are anticipated to not be able to participate due to permanent impairment as judged by the medical team.

Keywords: intensive care unit
impact of intestinal microbiota on uremic toxins productions

Conditions: CKD; Uremia

Summary: chronic renal failure (ckd) affects 3 million people in france and is characterized by the accumulation of uremic toxins (uts) such as p-cresyl sulfate (pcs) and indoxyl sulfate (is) which participate in cardiovascular complications and disturbance of the carbohydrate metabolism associated with ckd. these uts are not eliminated by dialysis due to their high affinity for albumin and alternative strategies to dialysis must be developed to decrease the production of tus in patients not yet in dialysis. the dysregulation of the intestinal microbiota observed during ckd increases the generation of uts in the intestine, by the transformation of amino acids derived from proteins (such as tyrosine and tryptophan transformed respectively into pcs and, is). thus, modulation of the intestinal microbiota seems to be an attractive target for reducing the production of uts and the comorbidities associated with ckd. some studies have demonstrated the potential interest of probiotics in lowering the plasma concentration of uts, but the effects remain unclear. in order to test the interest of probiotics during ckd, the investigators have, in collaboration with the nestlé laboratory and the prodigest platform, the possibility of testing probiotics using a human intestine simulator before the investigation of experimental and human models. for this the investigators would need a collection of fresh stools. the fresh stools will be instilled in artificial intestine to test the efficacy of selected probiotics on uts production.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old * non diabetic (fasting blood glucose \<1.26 g / l, or lack of insulin or oral antidiabetic treatment) * bmi between 18 and 30 kg / m² * patient with ckd stage 4-5 ( edfg \< 30 ml/min/1.73m2 ckd-epi) * not dialyzed * no history of kidney transplant * patient followed in the nephrology department of pr fouque at the lyon sud hospital center exclusion criteria: * active inflammatory, infectious, cardiovascular or neoplastic disease * colectomy, resection of the small intestine or cholecystectomy * patient having received antibiotics, prebiotics, probiotics in the last 3 months. * patient using laxatives (more than 2 doses per day for the last 3 months) * known renal pathology or known urologic malformation (healthy volunteer only)

Keywords: ckd uremic toxin probiotics intestinal microbiota artificial intestine