Kornimate/medical-research-clean huggingface dataset:
ultrafast truxima infusion in non-hodgkin's lymphoma: txagorapid study

Conditions: Non-Hodgkin's Lymphoma

Summary: the objective of this pilot study is therefore to assess the safety of truxima ultrafast infusion within 30 minutes in patients with non-hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * patients who have tolerated the maximum rate of intravenous administration of rituximab (400 mg/h) in the first or second infusion. * the last rituximab infusion must have occurred within the last 3 months. * all patients receiving rituximab can be included, regardless of whether they receive rituximab as monotherapy or in combination with chemotherapy and regardless of the line in which they are receiving it. * patients will be included in both induction and maintenance treatment. * all patients must sign the informed consent form. exclusion criteria: * patients with initial absolute lymphocyte count \>10x10\^3 cells/µl. * patients who have presented hypersensitivity and severe adverse effects (grade ii or higher) in the first or second infusion. * severe heart failure (nyha class iii-iv) or uncontrolled severe cardiac disease. * respiratory failure, severe uncontrolled copd/asthma. * patients allergic to premedication: acetaminophen or polaramine. * severe active infection. * pregnant patients. * refusal to participate.
cone beam ct for diagnosis of select otorhinolaryngology (ent) indications at lower dose

Conditions: CerebroSpinal Fluid (CSF) Leak; Chronic Otitis Media; Otospongiosis; Otosclerosis; Pulsatile Tinnitus; Cholesteatoma

Summary: the study objective is to compare the cbct images generated by the cs 9300 to those generated by conventional ct.

the study objective is to compare the cbct images generated by the cs 9300 to those generated by conventional ct. it proposes a direct comparison of diagnostic image quality between the cs 9300 and ct for the ability to view and confirm ent disorders.

Eligibility criteria:
inclusion criteria: * subject must be 18-80 years of age * subjects has provided informed consent * subjects must present with symptoms and/or pathology of the sinus or temporal bone region. * subject scheduled for additional radiological follow-up and/or endoscopy/surgery. * cbct exam performed within a maximum of 2 days of the conventional ct. exclusion criteria: * subjects under the age of 18 years, or over the age of 80 years * unable to collect all required case information * subjects not willing to consent, or consent is withdrawn * women in pregnancy or suspected of being pregnant confirmed by pregnancy test
constraint-induced movement therapy in chronic stroke patients

Conditions: Stroke

Summary: the aim of this study is to evaluate the feasibility of a home-based constraint-induced movement therapy (hcimt) compared to a modified constraint-induced movement therapy (mcimt) delivered in a outpatient setting on upper limb motor recovery in stroke survivors.

home-based constraint induced modified therapy (hcimt) consist of 2 hours intensive upper limb practice with shaping techniques + 2 hours adls supervised by a caregiver. patients are supposed to wear a mitt on the unaffected hand for 4 hours daily. modified constraint induced modified therapy (mcimt) consist of 2 hours intensive upper limb practice with shaping techniques supervised by an experienced physiotherapist + 2 hours adls at home (supervised by a caregiver) patients are supposed to wear a mitt on the unaffected hand for 4 hours daily.

Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 80 years * diagnosis of first ischemic stroke * stroke onset \> 6 months prior to study enrollment * upper extremity hemiparesis with impairment of hand and/or arm: * active wrist extension ≥20º * active metacarpophalangeal- and interphalangeal-joints extension ≥ 10° * muscle tone assessed by the modified ashworth scale (mas) ≤ 2 * pain assessed by the visual analogue scale (vas) \<4 exclusion criteria: * anyone who does not have adequate understanding of verbal or written information in italian sufficient to complete any test * impaired cognitive functioning: score less than 24 on the mini mental status examination (mmse) * contraindications to single-pulse transcranial magnetic stimulation (tms)(tms will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants) * neurological or psychiatric pathology * severe cardio-pulmonary, renal, hepatic diseases * pregnancy
sit-to-stand test in cystic fibrosis children and adolescents

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a chronic hereditary respiratory disease. exercise testing is part of cf patients regular assessment. cardio-pulmonary exercise testing (cpet) is currently considered as the gold standard to assess physical capacities. however, simple field tests are emerging. these tests are easier to perform especially in a population of cf children and adolescents. the 1minute sit-to-stand test have recently been evaluated in cf adults. this test correlates with maximal oxygen consumption during cpet. the investigators hypothesized that this test also correlates with 6-minute walking distance (during a 6-min walk test), quadriceps strength, respiratory muscles strength and health-related quality of life.


Eligibility criteria:
inclusion criteria: * cystic fibrosis * exacerbation-free last month before inclusion exclusion criteria: * cardiovascular, neurological or musculoskeletal contra-indications to exercise testing * other respiratory disease (kyphoscoliosis, asthma ...) * exacerbation * unability to carry out field tests

Keywords: cystic fibrosis exercise testing muscular strength pediatrics quality of life
prospective evaluation of oral antibiotics for treatment of shoulder pji

Conditions: Periprosthetic Infection; Oral Antibiotics; Revision Total Shoulder Arthroplasty

Summary: cutibacterium acnes (c. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. it is increasingly recognized as a pathogen, mainly in implant-related infections. as an anaerobe, it usually needs a prolonged culture incubation time of up to 14 days for growth and the association between implant surgery and c. acnes infection is not always obvious. unfortunately, prolonged incubation also increases the risk of false positive cultures in isolating organisms that may exist as a result of contamination. given high rates of positive c. acnes cultures in cases of both primary and revision shoulder surgery, the ramifications of positive c. acnes cultures for clinical decision making remains uncertain. the purpose of this study is to prospectively study the efficacy and side-effect profile of surgical treatment plus an oral antibiotic regiment for shoulder pji with indolent organisms (c. acnes and cns).


Eligibility criteria:
inclusion criteria: 1. all patients undergoing single-stage revision arthroplasty with all implants exchanged, 2. all patients undergoing single-stage revision arthroplasty with some implants retained, 3. all patients undergoing explantation of a shoulder arthroplasty and placement of an antibiotic spacer exclusion criteria: 1. patients with polymicrobial infection, 2. patients with infection by organisms other than p. acnes or coagulase negative staphylococcus, 3. patients with clinical suspicion of infection but negative cultures, 4. patients with no preoperative or intraoperative signs of infection and only 1 positive culture.
muscular respiratory involvement and systemic sclerosis

Conditions: Systemic Sclerosis; Diaphragm Defect; Respiratory Insufficiency; Pulmonary Function Test; Diaphragmatic Electromyography; Muscular Weakness

Summary: dyspnea in systemic sclerosis (scs) constitute a major factor of functional disability. intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors. diffuse fibrosing myopathy of bad prognosis have been reported in scs.to now, muscular respiratory involvement has not been evaluated in scs. therefore, scs patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (pft). this project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in scs and to evaluate a screening strategy of this involvement.


Eligibility criteria:
inclusion criteria: * age ≥18 years-old * scs fulfilling acr/eular 2013 classification criteria and followed in the department of internal medicine of poitiers university hospital * written informatory consent exclusion criteria: * individuals under tutorship or guardianship * individuals with reinforced protection: minors, judiciary or administrative decision * no affiliation to social insurance * pregnancy or breastfeeding * associated neuromuscular disease (myasthenia, degenerative diseases) * bedridden individuals or with health condition not allowing realization or interpretation of pft and/or emg (acute cardiac and/or respiratory failure, pneumopathy) * individuals with pacemaker and implanted pumps, especially sensing dispositives, as defibrillators ( relative contre-indication to emg with magnetic stimulation) * individuals with contre-indication to gastroesophageal probe: inr \>4, oesophageal varices, suspected cardio-facial fracture, oesophageal and/or facial obstacle
venous disease thromboembolic and amyotrophic lateral sclerosis

Conditions: Lateral Amyotrophic Sclerosis; Venous Thrombo-embolic Desease

Summary: venous thrombo-embolic (vte) rates could be high in patients with amyotrophic lateral sclerosis (als). indeed, the rate of vte in this specific population could be 7-fold higher in this population. predictiv factors of vte in patients with als are mobility reduction and neurological paralysis. however, to our knowledge, medical littérature is poor concerning vte and als association. our first aim is to define annual rate of vte in als population.then we aim to identify predictiv factors of vte in this specific population. the studied population is brest universitary hospital cohort of als patient included between 2000 and 2019.


Eligibility criteria:
inclusion criteria: * patients with amyotrophic lateral sclerosis defined by revised el escorial score criteria followed in competence centre of brest universitary hospital during 2000 to 2019 exclusion criteria: * no consent * other neuro-degenerativ diseases

Keywords: lateral amyotrophic sclerosis venous thrombo-embolic desase pulmonary embolism deep venous thrombosis
biotherapy treatment on features of microcrystalline polyarthritis

Conditions: Crystal-Induced Arthritis

Summary: the study will involve adult patient who had received any biologic agent for microcrystalline disease in western france (tours, le mans, orléans, angers, rennes, poitiers et brest) between 01/01/2010 and 31/12/2018. investigators will answer retrospectively a questionnaire that covers patient and disease data, biologic agent use, efficacy and adverse events.

this is a retrospective multicentric study of all patients treated by biologic for microcrystalline disease in france in western france (tours, le mans, nantes, la roche sur yon, orléans, angers, rennes, poitiers et brest) between 01/01/2010 and 31/12/2018. the investigators will collect all clinical (diagnosis of gout ccpd or hydroxyapatitis, tender and swollen joint count), biological (blood results: esr, crp, uric acid, synovial analysis), radiological data (x-rays performed and their description) .

Eligibility criteria:
inclusion criteria: * crystal- induced arthritis * treatment by biologic * in western france exclusion criteria: * none

Keywords: crystal-induced arthritis
targeted intraoperative radiotherapy (targit) registry database

Conditions: Early-Stage Breast Carcinoma

Summary: this is a prospectively registered database of patients with early breast cancer who will be treated with radiotherapy during surgery. more than 2000 women have already received this treatment in clinical trials. this study will monitor the health status of women who receive this treatment outside of a clinical trial, especially those who might not have been eligible for the original clinical trials. the aim is to confirm the long-term effectiveness and safety of the technique.

registration of patients selected for this treatment; collecting data regarding safety and toxicity on patients who have had treatment with targit. outcomes will be measured over short and long terms. outcome measures will include effectiveness and safety, assessed in various cohorts of patients. core outcomes will be used for effectiveness. in addition, true recurrence (basically, ipsilateral breast tumor recurrence at the same site as the original primary) will be used as defined by recht. safety outcomes will be based on common toxicity criteria. budget impact analysis of iort in subgroups of patients will be assessed. this amounts to using cost data to calculate the mean incremental (or extra) cost per person treated using intraoperative radiotherapy (iort) versus external beam radiotherapy (ebrt) and mastectomies (where iort could have been given instead) and then multiplying this by the total patients eligible nationally for iort, to calculate the total expected budget impact on the nhs if iort in these subgroups was rolled out nationally.

Eligibility criteria:
inclusion criteria: * recommended treatment by mdt * consent has been obtained to have patient data to be collected exclusion criteria: * pregnancy (females who have a positive pregnancy test prior to surgery) * under 18 years of age
obesity and caries in young south asian children: a common risk factor approach

Conditions: Pediatric Obesity; Early Childhood Caries

Summary: the chalo ("child health action to lower oral caries and obesity") -- from an urdu word meaning "let's go!"-is a multi-level strategy to reduce pediatric obesity and dental caries risk in south asian (sa) children. obesity and caries are the two most prominent health disparities of early childhood. both caries and obesity: a) disproportionately impact low-income children of color, b) share common risk behaviors, i.e., feeding practices, and c) can most effectively be reduced or prevented prevention in infancy and early childhood. sa immigrant children are at high risk for both. chalo includes both a randomized controlled trial (rct) aimed at reducing risk behavior, and a knowledge translation project to raise awareness in sa lay and professional communities regarding child health risks.

chalo builds upon the team's prior research re: cariogenic (r34-de-022282) and obesogenic behaviors (10, 14, 15). chalo's intervention components-- home visits, phone support, and "patient navigation" to dental visits-- proved to be feasible and acceptable. in the pilot r34, there were promising behavioral change on all measures. chalo builds on this work, with the addition of: a) sippy cups as an intervention target, b) an ipad-based dietary recall tool, "mysmilebuddy," c) caries and obesity data, and; d) increased intervention contacts- consistent with recent child obesity and caries interventions (16, 17). an rct (aim 1) will enroll 360 mothers of children 4-6 month olds from new york city (n=3) and new jersey (n=2) pediatric practices in sapphire ("sa practice partnership for health improvement and research"). the community health worker intervention includes: a) home visits with mothers/families (n=6 visits over one year) and follow up telephone support; b) patient navigation to make/keep timely dental visits (2x by 18 months). the knowledge translation component (aim 2) will raise awareness of child health risks in sa communities and among professionals who provide their care. the campaign will include both traditional and social media components and will be evaluated using multiple metrics.

Eligibility criteria:
inclusion criteria: * age: child is \< 6 months of age at time of recruitment * insurance: child is enrolled in either medicaid or chip * nativity- mother was born in india, pakistan, or bangladesh) * language- mother speaks standard bengali, english or hindi/urdu * agency- mother is index child's primary caretaker. exclusion criteria: * inability to provide informed consent per ra judgment * plans to travel for \> 1 month during follow-up, and * child health condition barring participation (per pediatrician review of recruitment lists).
triage survey for psychiatry research eligibility

Conditions: Major Depressive Disorder; Borderline Personality Disorder; Generalized Anxiety Disorder

Summary: triage-psych is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored psychiatry clinical trials.


Eligibility criteria:
inclusion criteria: * participant or legally authorized representative has signed an icf prior to study-specific procedures being performed. * participant is at least 18 years old. exclusion criteria: * participant is pregnant, breast-feeding, or planning to become pregnant. * history of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results. * participant represents an acute suicidal risk, as defined as a "yes" response to ideation on c-ssrs questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening. * moderate or severe substance use disorder within 90 days prior to screen, according to dsm-5 criteria that in the investigator's opinion could pose undue risk to the participant. * any condition that in the investigator's opinion makes a participant unsuitable for the study. * currently employed by adams clinical or a first-degree relative of an employee.
open-label extension: tolerability and effects of alk-001 on stargardt disease (tease)

Conditions: Stargardt Disease; Stargardt Macular Degeneration; Stargardt Macular Dystrophy; Autosomal Recessive Stargardt Disease 1 (ABCA4-related)

Summary: the purpose of this open-label, multicenter study is to determine the long-term safety, pharmacokinetics and effects of alk-001 (c20-d3-retinyl acetate) on the progression of stargardt disease. this study is an extension of nct02402660 and enrolls participants who are at least 8 years old. enrollment is by invitation only. funding source - fda oopd


Eligibility criteria:
simplified inclusion criteria: * clinical diagnosis of stargardt disease (stgd1) * has at least two abca4 disease-causing mutations, unless authorized by sponsor * has a best-corrected visual acuity (bcva) greater than approximately 20/160 in at least one eye * healthy as judged by investigator * able and willing to comply with study requirements, restrictions and instructions and is likely to complete the 24-month study * has been invited to participate in this extension, and has signed and dated the informed consent forms (or assent where appropriate) to participate * female of childbearing potential has signed the attestation on contraception requirements simplified exclusion criteria: * is lactating or pregnant * has a medical condition likely to prevent compliance with the protocol and/or interfere with absorption of alk-001 or performance of study procedures * has abnormal laboratory result(s) at screening * has an ocular disorder that may confound ocular assessments * has a history of ocular intervention within 90 days of screening
eras anesthetic care for metastatic spine cancer resection

Conditions: Metastatic Bone Tumor

Summary: spinal metastases account for 60% of all malignant bone metastases and represent a medically important treatment goal. for patients with malignant tumors diagnosed at this stage, performing en bloc spondylectomy with wide margin of resection facilitate the improvement in quality of life including ambulatory ability, daily activities independence and attenuation of bone pain. however, en bloc spondylectomy is a major operation with long operation time and frequent hemodynamic instability during the operation. therefore, the anesthetic care plays an important role and an enhanced recovery after surgery (eras) is the goal. for the eras anesthesia protocol for en bloc spondylectomy, we propose two major components to achieve this goal: (1) an encephalographic spectrum guided multimodal anesthesia combined with ultrasound-guided nerve block and (2) the advanced machine-learning algorithm index, namely the hypotension predictive index (hpi) guided hemodynamic protocol.

the anesthetic protocol comprises of two major proposed components to enhanced recovery after spine cancer total en bloc resection. first, a multimodal general anesthesia consisting of gabanergic hypnotic agent (propofol or sevoflurane), ketamine and dexmedetomidine was conducted by using the encephalographic density spectrum array. in addition, ultrasound-guided erector spinae plane block is applied. these techniques potentially prevent anesthesia induced delirium and may profoundly improve postoperative analgesic quality. second, advanced hemodynamic monitoring device, namely the hypotensio predictive index, will be used for prevention of intraoperative hypotension and facilitate precise transfusion protocol.

Eligibility criteria:
inclusion criteria: * patients undergoing metastatic spine cancer resection surgery exclusion criteria: * expected survival less than 6 months * previous surgery or radiotherapy for the spine metastasis
effect of woodsmoke on vascular function

Conditions: Vascular Function

Summary: exposure to air pollution is a well established risk factor for the development of heart disease. firefighters are exposed to excess air pollution in the form of wood smoke during the extinguishing of forest or woodland fires. heart attacks in on-duty firefighters have been linked to specific duties and in particular fire suppression, but the reasons for this increase in risk are not well understood. exposure to wood smoke may alter blood vessel function and increase blood clot formation to explain the link between fire suppression and heart attacks. the investigators wish to determine the effect of exposure to wood smoke at concentrations found at the perimeter of a woodland fire on blood vessel function and clotting in healthy non-smoking male professional firefighters or volunteers. volunteers will be studied before and after inhalation of wood smoke or clean air for one hour in a purpose built whole-body exposure chamber. the investigators will perform comprehensive vascular assessments thereafter. understanding the effects of wood smoke on the blood vessels and clotting will be an important first step in helping to protect firefighters from heart disease. through research, the investigators hope to identify methods to minimise the risk of heart attacks in firefighters and understand the health effects of a major source of air pollution that is relevant to the general population.


Eligibility criteria:
inclusion criteria: * non-smoking healthy male firefighters or volunteers exclusion criteria: * current smoker or regular users of snus * history of lung or ischaemic heart disease * malignant arrhythmia * systolic blood pressure \>190mmhg or \<100mmhg * renal or hepatic dysfunction * previous history of blood dyscrasia * unable to tolerate the supine position * blood donation within the last 3 months * recent respiratory tract infection within the past 4 weeks * routine medication including aspirin and nsaids

Keywords: firefighter woodsmoke vascular function air pollution endothelial function thrombosis