Kornimate/medical-research-clean huggingface dataset:
breast cancer women on aromatase inhibitors treatment

Conditions: Osteoporosis; Osteoporosis Fracture; Arthralgia Generalized

Summary: the main objective of the study is to improve the life quality of women treated with ai. cohort b-able is designed to evaluate musculoskeletal events derived of using ai in breast cancer women. the project objectives are the analysis of the ai deleterious effect on bone microarchitecture and early determination of the risk of fragility fracture with dual energy x-ray absorptiometry (dexa), lumbar spine rx, trabecular bone score (tbs) and microindentation. determination of physiological causes of the ai-related arthralgia by analyzing joint degradation markers, steroid hormone levels remaining in blood and functional magnetic resonance, before and after three months of ai treatment

postmenopausal women with breast cancer treated with aromatase inhibitors (ai) have a higher incidence of osteoporosis, fractures and other musculoskeletal symptoms, particularly pain and stiffness. b-able is a clinical, prospective cohort study carried out in both breast cancer and bone metabolism units of the hospital del mar in barcelona. currently, 780 postmenopausal caucasian women with early breast cancer and candidates for adjuvant ai treatment were included and predicted to reach more than 1000 patients. the main objective of the study is to improve the life quality of women treated with ai. cohort b-able is designed to evaluate musculoskeletal events derived of using ai in breast cancer women. the project objectives are the analysis of the ai deleterious effect on bone microarchitecture and early determination of the risk of fragility fracture with dexa, lumbar spine rx, tbs and microindentation. determination of physiological causes of the ai-related arthralgia by analyzing joint degradation markers, steroid hormone levels remaining in blood and functional magnetic resonance, before and after three months of ai treatment. the study results will help to decide the most appropriate treatment for each patient in order to minimize ai-related side effects and hence avoid discontinuation of adjuvant therapy treatment.

Eligibility criteria:
inclusion criteria: * postmenopausal women with early breast cancer estrogen receptor with aromatase inhibitors treatment exclusion criteria: * previous treatment with antiresorptive treatment for osteoporosis secondary osteoporosis, as corticosteroids, hyperparathyroidism, kidney chronic disease, previous treatment with aromatase inhibitors diabetes mellitus type 1 fibromyalgia

Keywords: osteoporosis aromatase inhibitors breast cancer microindentation arthralgia musculoskeletal pain
predicting the safety and effectiveness of inferior vena cava filters

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Summary: preserve is a multi-center, prospective, open-label, non-randomized investigation of commercially available ivc filters from 6 manufacturers placed in subjects for the prevention of pulmonary embolism (pe). this study will enroll up to 1,800 ivc filter subjects (with a maximum of 300 subjects per ivc filter brand) at up to 60 sites in the us. the primary objective of this investigational device exemption (ide) clinical investigation is to evaluate the safety and effectiveness of the commercially available ivc filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of pe with an ivc filter.

the overall goal is to characterize the current practice of ivc filter placement, including the indications, filter type, frequency and success of filter removal, safety of placement initially and in the long term, including filter mechanical stability and caval patency, and the frequency of subsequent episodes of pe and recurrence of dvt. the first steps are to identify the characteristics of use in a broad range of clinical practice settings in the us. commercially available ivc filters from 6 manufacturers in the united states will be used. the type of fda-cleared ivc filter implanted will be left to the discretion of the principal investigator at the site. the following ivc filters will be utilized in this trial: 1. aln vena cava filter (with and without hook) (aln implants chirurgicaux) 2. option™ elite retrievable vena cava filter (argon medical devices inc., designed and manufactured by rex medical) 3. venatech® lp vena cava filter (b braun interventional systems, inc.) and venatech® convertible™ vena cava filter 4. denali® vena cava filter system (dl900f, dl900j) (bard peripheral vascular, inc.) 5. cook günther-tulip™ vena cava filter (cook incorporated) 6. cordis optease® retrievable vena cava filter and cordis trapease® permanent vena cava filter (cordis corporation) subjects will be evaluated at procedure, discharge, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. all subjects in whom the ivc filter is removed will be followed for 1-month postretrieval. mandated follow-up imaging will be performed at 3 months (plain film) and 12 and 24 months (contrast abdominal ct). in addition, clinical visits with physical exam will be performed at 3 months, 12 months and 24 months.

Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older; * requires ivc filter for prevention of pulmonary embolism (pe); * provide written informed consent and written hipaa authorization prior to initiation of study procedures; * willing to comply with the specified follow-up exclusion criteria: * subject is unable to participate in study evaluations pre- and post-treatment * known sensitivity to contrast or serious contrast reaction such as anaphylaxis for which premedication is known to be unsuccessful in alleviating symptoms

Keywords: inferior vena cava filters
mindfulness meditation and cannabis dependence : therapy effectiveness

Conditions: Addiction; Cannabis Use; Cannabis Dependence

Summary: cannabis use can lead to addiction in about 5 to 10 % of users in france. currently, behavioral interventions are the most dependable but effectiveness is still reduced. mindfulness meditation has demonstrated an effectiveness in several meta analysis (anxiety and depressive disorder) and seems to be relevant to reduce anxious and impulsive symptoms found in cannabis use disorders. this study proposes to determinate the mindfulness effectiveness in reduction of cannabis use in regular consumer. the consumption decrease is estimated with a retrospective diary, tlfb (timeline follow back) which collect cannabis use every week until the 12th. urine (week 0/baseline, 2, 4, 6, 8, 10, 12) and hair (week 0/baseline, 10) analyses are regularly effected. patients included in control group get classic cares in an addictology center in chru of nancy. patients included in mindfulness group receive one session a week during eight weeks (mbrp protocol : mindfulness -based relapse prevention). the study process goes on for 12 weeks. an ancillary study measures the impact of cannabis decreases on retinal electrophysiological and architectural markers, usually disturbed by cannabis uses.


Eligibility criteria:
inclusion criteria: * aged from 18 to 55 * cannabis use: more than 7 joint a week or diagnostic of abuse/dependence at mini (mini international neuropsychiatric interview) * recent use authenticated in urine * patient voluntary to stop cannabis use * patient with social security * written consent for study exclusion criteria: * alcohol dependence (audit: alcohol use disorders test) * other psychoactive substance abuse or dependence (dsm 4) * progressive psychiatric disorder (minii) excepted anxious disorder) * current neurologic disorder * patient deficiency with difficulty or impossibility to understand informations * protection of vulnerable adults as guardianship or judicial protection * pregnant or breastfeeding woman * vital emergency * no social security * participation in another interventional study * current retinal disorder (ancillary study) * chronic glaucoma (ancillary study) * opthalmologic disease decreasing visual acuity (ancillary study) * current ocular infection

Keywords: mindfulness cannabis use
study of urinary predictors of exacerbations by biomarkers in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: study of urinary predictors of exacerbations by biomarkers in cystic fibrosis

people with cystic fibrosis (cf) are prone to chest infections (pulmonary exacerbations) and suffer premature death due to respiratory failure. patients that experience more frequent pulmonary exacerbations have worse prognosis and early antibiotic treatment of pulmonary exacerbations is therefore one of the major goals of cf care. antibiotic treatment is often currently delayed, since we rely on patients contacting the cf team when they develop worsening symptoms. we hypothesise that if we could allow patients to detect and receive treatment for early pulmonary exacerbations by measuring urinary biomarkers, this would minimise lung damage and result in improved clinical outcomes. in phase 1, 40 patients will be asked to collect daily urine samples, in addition to recording daily spirometry and a daily symptom score for 4 months. phase 1 aims to identify the urinary biomarkers that are associated with cf pulmonary exacerbations. in phase 2, the same 40 patients will be asked to collect and test a daily urine sample using a novel testing device in addition to recording daily spirometry and a daily symptom score for 4 months. phase 2 aims to validate the use of the urine testing device as a method of diagnosing early pulmonary exacerbations. in summary, this study aims to develop and validate a novel noninvasive point of care (near-patient) diagnostic testing system, to allow people with cf to diagnose early pulmonary exacerbations by measuring urinary biomarkers. if successful, we hope that this will provide patients with an easy to use device, which will empower patients and their caregivers to treat exacerbations at an earlier stage, with potential health and economic benefits.

Eligibility criteria:
inclusion criteria: * confirmed cf diagnosis * aged \>18 years of age * patients able and willing to give informed consent * requirement for at least one course of intravenous antibiotics for a pulmonary exacerbation within the previous 3 months. exclusion criteria: * patients not able or not willing to give informed consent * patients who are currently participating in another clinical trial (excluding observational studies) * pneumothorax or lung surgery within the previous 3 months, eye surgery (e.g. cataract operation) in the previous 4 weeks, or any other factor that prevents safe measurement of spirometry.
effects of remifentanil on cardiac function in patients with diastolic dysfunction

Conditions: Diastolic Dysfunction

Summary: in this study asa 1, 2 individuals with grade 1 or 2 diastolic dysfunction will be recruited to assess the effects of remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy.

our aim in this study is to evaluate the effects of remifentanil infusion on left ventricular function evaluated with transthoracic echocardiagraphy on asa 1, 2 individuals with grade 1 or 2 diastolic dysfunction. methods: 30 asa 1-2 individuals with grade 1 or 2 diastolic dysfunction whose left ventricular ejection fraction is above 50% will be recruited. the patients will be selected among the ones who planned to undergo elective surgery either under general or regional anesthesia. patients with atrial fibrillation, atrioventricular block, severe heart valve disease, tachyarrhythmia-bradyarrhythmia, left ventricular ejection fraction \ 30 kg/m2, no oral intake for solid food more than 8 hours will be excluded from the study. baseline echocardiographic examination will be performed in the spontaneously breathing subjects right before the surgical procedure and study drug begins. then remifentanil infusion will be started at a rate to reach target plasma level of 2 ng/ml. a target controlled infusion pump will be used to infuse the study drug. once the target drug concentration is reached, the final echocardiographic examination will be performed. after recording the baseline heart rate, respiratory rate, noninvasive blood pressure, pulse oximeter, sedation level, the same parameters will be recorded every 5 minutes during the remifentanil infusion period. once the final echocardiographic evaluation is performed abovementioned parameters will be recorded for the last time. statistical analysis: the sample size calculation is made according to an increase or decrease in e/e' (alpha \<0,05; beta= 0,8).

Eligibility criteria:
inclusion criteria: * 60 years of age or older asa 1, 2 adults with first or second degree diastolic dysfunction. exclusion criteria: * atrial fibrillation, atrioventricular block, tachyarrhythmia, bradyarrhythmia, left ventricular ejection fraction lower than 50%, body mass index \>30 kg/m2, liver, kidney and lung disease.

Keywords: diastolic dysfunction remifentanil
leo 27847 - safety, tolerability, pharmacokinetic and pharmacodynamic study in secondary hyperparathyroidism patients

Conditions: Secondary Hyperparathyroidism

Summary: the purpose of this trial is to determine the safety and tolerability of ascending single and multiple oral doses of leo 27847 in secondary hyperparathyroidism patients.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 75 years (inclusive) at screening. * patients with body mass index within 18 to 34 kg/m2 (inclusive). * haemoglobin is stable (≥9 g/dl or 5.6 mmol/l) * parathyroid hormone (pth) is ≥200 pg/ml and \<800 pg/ml. * screening serum albumin is ≥30 g/l. * c-reactive protein \<25 mg/l. exclusion criteria: * adjustment of vitamin d sterols within 14 days before the screening visit and patients for whom adjustment of vitamin d sterols is planned from screening until end of study. * adjustment of calcium supplements within 14 days before the screening visit and patients for whom adjustment of calcium supplements is planned from screening until end of study. * adjustment of phosphate binder within 14 days before the screening visit and patients or whom adjustment of phosphate binder is planned from screening until end of study.

Keywords: safety and tolerability of leo 27847
the use of dantrolene to improve analgesia in posterior lumbar surgery

Conditions: Lumbar Spine Injury

Summary: the purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the overall benefit of analgesia score (obas), and richmond agitation sedation scale (rass) scores in patients undergoing lumbar fusion.


Eligibility criteria:
inclusion criteria * 18 - 80 years of age (inclusive) * presenting to the study hospital for lumbar decompression and/or fusion (instrumented fusion of the lumbar spine \< 4 levels) under general anesthesia, and scheduled for same-day admission or in-patient admission * american society of anesthesiologists (asa) category 1, 2 or 3 exclusion criteria * known allergy to dantrolene, morphine or other opioids, benzodiazepines that causes a reaction of hives, anaphylaxis, shock, unconsciousness/fainting, rashes/blisters, irregular heartbeat, fever, swelling, shortness of breath, wheezing, serum sickness, drug induced anemia, drug reaction with eosinophilia, and systemic symptoms, or nephritis * oxygen saturation \< 94% * patient being treated with any of the following medications:non-dihydropyridine calcium channel blockers including verapamil, estrogen therapy * current or past medical history of any of the following: hepatic impairment (including history of transplant), renal impairment or chronic renal disease (including history of transplant), chronic alcohol abuse, chronic respiratory disease (i.e. chronic hypoxia or hypercapnia, copd) * recent history of aspiration (within the last 3 months) * patients with any history of neuromuscular dysfunction * history of obstructive sleep apnea * weight \> 140 kg * currently pregnant * actively breastfeeding * inability to provide written informed consent

Keywords: surgery dantrolene anesthesia
manual ankle rocking training on postural control and foot function in children with down syndrome

Conditions: Down S Syndrome

Summary: down syndrome occurs due to abnormal cell division of extra chromosome 21. it is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent. strengthening exercise of lower limb and core strengthening of trunk muscle will provide postural stability and lower limb strengthening. aim of this research is to determine the effects of manual ankle rocking training on postural control and foot function in children with down syndrome. those who are diagnosed with down syndrome and are between age 8-15 and both of the genders are included in this research and those who have any surgical issue, visual impairment and musculoskeletal contractures are not included in the study we will use static standing balance test to check postural control and foot function index for ankle rocking training from two group in which one will be given the baseline treatment of lower limb exercise and core strengthening with ankle rocking training and the other group without ankle rocking training and then the collected data will be analyzed by spss. 22


Eligibility criteria:
inclusion criteria: * diagnosed children with down syndrome * age 8 to 15 * both gender (male and female) exclusion criteria: * musculoskeletal contractures * visual or other sensory input impairment * any surgical procedure

Keywords: down syndrome postural control postural stability balance
polysomnographic findings in nasal polyposis

Conditions: Chronic Rhinosinusitis With Nasal Polyps; Obstructive Sleep Apnea

Summary: nasal polyposis (np) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. prevalence of np among the chronic rhinosinusitis patients is 25-30 %. np leads to significant limitations in physical, emotional and social aspects of life of the affected patients. sleep disorder is frequently reported by those patients with impaired nasal breathing. till now few studies have objectively assessed the impact of np on sleep quality. the objectives are to figure out sleep disturbances in np and to analyze the outcomes of sinus surgery on sleep recovering.


Eligibility criteria:
inclusion criteria: * patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) social insured patient * patient willing to comply with all procedures of the study and its duration * patient giving consent exclusion criteria: * patients with previous nasal surgery for nasal polyposis * patients with previous continuous positive airway pressure therapy for obstructive sleep apnea * non-coverage by the social security scheme * patient unable to receive informed information * refusal to sign the consent * person deprived of the liberty * person benefiting from a system of legal protection (guardianship...)

Keywords: nasal polyposis sleep sinus surgery polysomnography quality of life
hypofractionated radiosurgery for localised prostate cancer

Conditions: Prostate Cancer

Summary: hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible. investigators initiated this multicenter phase ii prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer, who are ineligible for the "prefere trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.

experimental radiosurgery of prostate with 5 fractions each with 7,00 gy (total application rate of 35,00 gy). planned visits are: baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Eligibility criteria:
inclusion criteria: * localised, histopathologically confirmed prostate cancer (ct1-3 n0 m0) * gleason-grade ≤7 * guideline-based staging * age ≥ 60 years * psa \< 15 ng/ml * volume of the prostate \<80 cm³ * ipss-score ≤12 * written informed consent exclusion criteria: * history of prior pelvic radiotherapy * contraindication to mri or fiducial marker implantation (e.g. allergy to gold), * immunosuppressive therapy * relevant comorbidity thought to adversely affect treatment compliance, * legal incapacity or lack of informed consent

Keywords: hypofractionation prostate cancer radiotherapy
pleth variability index and hypotension

Conditions: Hypotension; Pleth Variability Index

Summary: correct assessment of a patient's volume status is the most important goal for an anesthetist. however, most of the variables used for fluid response evaluation are invasive and technically challenging.pulse oximeter is a non-invasive, standardized and widely used monitoring method in many countries. our aim in this study is to investigate the usefulness of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture patients who underwent spinal anesthesia.


Eligibility criteria:
inclusion criteria: * over 65 years old * patients to undergo spinal anesthesia exclusion criteria: * patients under 65 years old * patients to undergo general anesthesia or only sedation * patients with cardiac arrhythmia * patients with low ventricular ejection fraction * heart valve disease patients

Keywords: hypotension pleth variability index hip fracture spinal anesthesia
physical activity centers empowerment

Conditions: Colorectal Neoplasms

Summary: this research study tests the feasibility of the physical activity centers empowerment (pace) physical activity intervention for african american individuals diagnosed with colorectal cancer. feasibility will be measured as intervention reach, effectiveness, adoption, implementation, and maintenance. seventy-two subjects will be recruited to conduct a pilot two-group, randomized repeated measures study.

the purpose of this research is to improve the quality of life for underserved cancer survivors by increasing physical activity. a physical activity intervention will be tested for feasibility with african american cancer survivors. the project will serve as a foundation for intervening with other underserved cancer survivors. feasibility will be measured as intervention reach, effectiveness, adoption, implementation, and maintenance, following the re-aim framework. survey and biomarker data will be collected at baseline, 3 and 9 months later. these time points will facilitate exploration of changes pre- and post-intervention, and to determine if effects are maintained 6 months after completing the intervention. our primary hypothesis is that the intervention will be feasible to deliver.

Eligibility criteria:
inclusion criteria: 1. self-identifying as aa of black, 2. diagnosis of crc, 3. scheduled to receive chemotherapy, 4. age 18 years or older, 5. no contraindications to unsupervised pa as determined by the pa readiness questionnaire, 6. oncologist approval to participate, and 7. a smartphone for fitbit syncing.

Keywords: physical activity colorectal neoplasms health equity black or african american