Kornimate/medical-research-clean huggingface dataset:
safety of aerobic exercise in acute heart failure

Conditions: Heart Failure; Acute Heart Failure

Summary: this project deals with exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).

all of the subjects performed an individualized clinical evaluation right after hospital admission on day 1 (d1) by the cardiologist and physiotherapis involved in the study. pulmonary function tests (spirometry), blood sample (brain natriuretic peptide \[nt-probnp\] and high sensitive c-reactive protein \[hs-crp\]), six-minute walk test (6mwt), and maximal inspiratory pressure (mip) test were performed. after the clinical tests were performed, the patients were randomized into three groups, and all received standard medical treatment. the control group (ctl) received medical treatment and did not perform aerobic exercise training; the et+niv group performed aerobic exercise training associated with niv once a day, for 8 consecutive days; and the et+sham group performed aerobic exercise with placebo niv once a day, for 8 consecutive days. the et+niv and et+sham groups also received medical treatment. after eight consecutive days, all of the patients underwent a new clinical evaluation (d10). after d10, all of the patients continued to receive only conventional treatment, and they were followed up for main outcomes (hospital discharge, worsening hf, or death). worsening hf was considered when a patient needed to be transferred to the intensive care unit.

Eligibility criteria:
inclusion criteria: * established diagnosis of acute hf; previous doppler echocardiography with left ventricle ejection fraction (lvef) \<30%, and nyha class iv. exclusion criteria: * unstable angina, complex cardiac arrhythmias, pacemaker, cardiac resynchronization therapy or left ventricle assist device, myocardial infarction within the previous 12 months, oxygen saturation by pulse oximetry (spo2) at rest \< 88% without oxygen supplementation, acute pulmonary edema with clinical indications for mechanical ventilation

Keywords: exercise cardiac rehabilitation non-invasive ventilation
preoperative stereotactic radiosurgery for brain metastases

Conditions: Brain Metastases

Summary: step is a french multicentre, prospective, non-randomized, phase ii study designed to assess 6-months local control after pre-operative stereotactic radiosurgery (srs) for patients with brain metastases


Eligibility criteria:
inclusion criteria: * ≤ 4 distinct brain metastases, one with surgical indication * diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer * ≤ 5 cm larger diameter * karnofsky performance status ≥ 70 * no contraindication for mri * possibility for the patient to be treat with both surgery and stereotactic radiotherapy * ≥ 18 years old * estimated overall survival ≥ 6 months according to diagnosis specific - graded prognostic assessment (ds gpa) * written inform consent signed * affiliation to the french social security system * for women of childbearing age including those on luteinizing hormone-releasing hormone (lh-rh) agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative stereotactic radiosurgery (srs). exclusion criteria: * lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer * metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma * mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery * \> 4 brain metastases * contraindication to anaesthesia, mri or gadolinium injection * proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope * pregnant or breastfeeding woman * anti vascular endothelial growth factor (vegf) within 6 weeks before treatment * documented leptomeningeal injury * history of irradiation of the encephalon in toto * history of stereotactic radiotherapy on metastasis to be operated on * non-candidate patient for surgery * surgical delay \> 3 days compared to stereotactic radiotherapy * estimated survival \< 6 months by ds gpa * patient under guardianship or curators * psychological disorder (cognitive disorders, mental alertness, etc.) or social (deprivation of liberty by judicial or administrative decision) or geographical reasons that may compromise medical monitoring of the trial or compliance with treatment * woman of childbearing age without effective contraception * patient participating in another intervention study within 4 weeks prior to inclusion

Keywords: brain metastases preoperative stereotactic radiosurgery local control radionecrosis overall survival
the effect of phosphate lowering using sucroferric oxyhydroxide (pa21) on calcification propensity of serum

Conditions: Endstage Renal Disease

Summary: this is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.

patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) pa-21 followed by high-dose (2000mg/d) pa-21 (sequence a-b) or to receive high-dose pa21 followed by low-dose pa21 (sequence b-a) with washout-phases in between. an open label design with a sub-therapeutic dose of pa21 as control treatment was chosen because creating a convincing placebo for pa21 is not feasible. the study will start with two study visits on the 2nd and 3rd dialysis session of the week , where dialysis patients are still treated with standard of care to establish baseline values (duration: 0.5 weeks). next will be an initial run-in wash-out phase, where all phosphate binders taken by the patient as standard of care treatment will be discontinued and no phosphate binders will be introduced. consequently, there will be a pa21 treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another pa21 treatment (high dose/low dose) phase, followed by a final wash-out phase. each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 days of duration. patients will be followed up to 10.5 weeks after randomization until the last study visit of the final wash-out phase.

Eligibility criteria:
inclusion criteria: * prevalent patients (≥ 3 months on dialysis) treated with thrice weekly hemodialysis (hd) or hemodiafiltration (hdf) * hyperphosphatemia (serum phosphate \> upper limit of normal within the last 3 months) or current phosphate binder use * no use or constant dose of vitamin d and/or calcimimetics for ≥2 weeks exclusion criteria: * allergy to sucroferric oxyhydroxide (pa21), to other ingredients of velphoro or to any iron-medication * current or history of calciphylaxis (calcific uremic arteriolopathy - cua) * parathormone \>800 pg/ml * parathyreoidektomie planned or expected * significant gi or hepatic disorders * hypercalcemia (total serum calcium \>2.6 mmol/l) at screening * antacids containing aluminum, calcium, magnesium or bicarbonate * oral iron treatments/supplements * pregnant and nursing (lactating) women
lantus in prediabetes

Conditions: Hyperglycemia; Diabetes Mellitus

Summary: to assess the safety, tolerability, and efficacy of lantus® (insulin glargine) in prediabetes (ifg or igt).


Eligibility criteria:
inclusion criteria: * hyperglycemia (either igt , ifg, or untreated type 2 diabetes) * hba1c \< 7.0% * bmi \< 40kg/m2 * able to perform moderate stationary bicycle exercise exclusion criteria: * chronic pharmacologic treatment for hyperglycemia, past or present * cad * serum creatinine \> 2.0mg/dl * bp \> 180/105 * history of hypoglycemia unawareness

Keywords: glargine prediabetes impaired glucose tolerance impaired fasting glucose
blood naloxone levels following intradermal injection in humans

Conditions: Opioid Overdose

Summary: the main purpose of this study is to evaluate pharmacokinetics/pharmacodynamics of intradermal administration of naloxone in healthy adult subjects.

using approved drug formulations, injection devices, and assays, the investigators seek to determine the pharmacokinetics and pharmacodynamics of naloxone in human subjects using an intradermal delivery route. the long-term goal is to develop a product with better pharmacokinetic (pk) and pharmacodynamic (pd) properties than current delivery systems used in opioid overdose rescue. to the best of the investigators knowledge, this is the first study administering naloxone via an intradermal route in humans. using an fda-approved intranasal drug formulation, the investigators will administer 8mg/0.1ml of naloxone into the highly vascular dermal layer of the skin using microneedles in 3 healthy volunteer participants and measure plasma concentrations of naloxone for 60 minutes after injection. the investigators primary outcome measure is detectable levels of naloxone in plasma. secondary outcome measures will be estimates of pk values derived from time versus concentration data.

Eligibility criteria:
inclusion criteria: * ability to participate in the informed consent process * good peripheral venous access for proposed pharmacokinetic sampling * has not taken an investigational drug within prior 30 days (or 5 half-lives, whichever is longer) exclusion criteria: * allergy to naloxone or vehicle constituents (namely parabens) * active substance use as defined by a positive screen for drugs of abuse within seven days of study participation * history of substance use disorder * taking opiate/opioid medications for any indication * chronic pain disorder * pregnant or breastfeeding * adults lacking capacity to consent, non-english speaking persons, or prisoners. * other medical history or active conditions deemed not safe for participation by the investigator * hematocrit \<35%

Keywords: naloxone pharmacokinetics pharmacodynamics intradermal opioid receptor
post-operative pain management with nsaids

Conditions: Urogynecologic Surgery

Summary: specific aim 1: to identify differences in pain perception and satisfaction with pain control in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory (nsaids) postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac. specific aim 2: to compare the differences in narcotic usage and medication side effects.

all patient will be informed that they may receive either ibuprofen or ketorolac and that the medication may be given (iv) or per os (po). patients were also informed that their pain may improve or worsen during the study, and that they could request additional pain medication (as a rescue medication) at any time. after surgery, all patients will be placed initially on a patient controlled analgesia (pca) of hydromorphone with standardized settings of allowing the patient to dispense 0.2 mg of medication every 6 minutes (lockout rate) and an hourly maximum of 2.0 mg/hour. a one-time nursing bolus of 0.4 mg will also be ordered. the pca will be discontinued on the morning after surgery no later than 12:00 noon. the patient will then be started on po pain medication, either hydrocodone/acetaminophen or oxycodone/acetaminophen. immediately after surgery, patients will then be assigned to one of three treatment arms with a computer-generated randomization schedule that is to be based on their order of enrollment. patients were informed they could withdraw at any point. three visual analog scores (vas) will be obtained from the patient before noon on the first day after surgery. one scale to assess pain at rest, one scale to assess pain with ambulation, and one scale to assess satisfaction with pain control. the medications will each be given every 8 hours in order to keep all medications on a similar doing regimen. this will allow the patients to receive a total of three doses of medication over 24 hours, regardless of which arm of the study they are randomized to.

Eligibility criteria:
inclusion criteria: * female gender * available for reliable follow up * able to complete study assessment * scheduled for surgery by fpmrs surgeon exclusion criteria: * age \<18 years * known renal impairment * congestive heart failure * dementia or inability to follow instructions * allergy to nsaids * allergy to hydromorphone * history of gastrointestinal bleeding or ulceration * inflammatory bowel disease
piano training, caregivers, and parkinson's disease

Conditions: Depression; Mood; Burden, Dependency

Summary: the purpose of this study is to investigate the impact of group piano training on psychosocial outcomes in caregivers of adults with parkinson's disease (pd). as well, the study is investigating the impact of group piano training on psychosocial outcomes in the care-recipient with pd.


Eligibility criteria:
inclusion criteria: * caregiver: * are currently a primary caregiver to an adult with pd * are between the age of 40-80 years * have less than 5 years of music training * speak and read english fluently adult with pd: * stage 1-3 parkinson's disease * are between the age of 40-80 * have less than 5 years of music training * speak and read english fluently exclusion criteria: * doesn't meet all the inclusion criteria

Keywords: caregiver parkinson's disease group piano training
evaluation of desensitization protocols in reduction of dentin hypersensitivity

Conditions: Hypersensitivity Dentin; Dentin Sensitivity; Dentin Hypersensitivity; Dentine Hypersensitivity

Summary: the aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. the desensitization approach (single agent or associated agents) and the long-term effectiveness (baseline, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks) will be evaluated. data will be collected, tabulated and submitted to statistical analysis.

dentin hypersensitivity is characterized as an acute and short-term pain with multifactorial etiology. this condition is a clinical challenge due to the different treatment protocols available. therefore, the aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. thirty-two patients with dentin hypersensitivity in at least three teeth will be selected.the teeth will be randomly divided into two different groups according to the desensitization approach (single agent with neural action; single agent with obliterating action; associated technique (neural and obliterator agents). the dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2, 4,12 and 24 weeks. data will be collected, tabulated and submitted to statistical analysis.

Eligibility criteria:
inclusion criteria: * healthy individuals * both genres, interested in the treatment of dentin hypersensitivity * patients with all teeth in their mouth * patients who have at least three teeth with dentin hypersensitivity in different quadrants * good oral hygiene exclusion criteria: * caries or unsatisfactory restorations * presence of periodontal disease and or parafunctional habits * cracks or enamel fractures * extensive or unsatisfactory restorations * recent restorations involving the labial surface * pulpitis * dentures * orthodontics * smokers * pregnant women * gastroesophageal disease presence * uncontrolled systemic disease * severe bruxism * constant use of analgesic * allergic response to dental products
fgf-23 and pth in hemodialysis patients

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Summary: in this pilot study the investigator will examine the levels of fibroblast growth factor (fgf-23) and parathyroid hormone (pth) levels during hemodialysis therapy in 30 patients and assess the correlation between these parameters and the t-50 calcification propensity, as well as further parameters of secondary hyperparathyroidism (shpt), like serum calcium (sca), phosphate (p), 25-hydroxy-vitamin d (25(oh)d) and 1,25 dihydroxy-vitamin d (1,25(oh)2d). the investigator hypothesize that fgf-23 and pth levels are at their highest at the beginning of dialysis and decrease during the treatment.

background: the development of shpt in hemodialysis patients is a common complication which induces an increase in calcification and atherosclerosis. elevated fgf-23 levels are already found in early stages of chronic kidney disease (ckd) and it has been shown that high fgf-23 levels are associated with the development of cardiovascular disease and increased overall mortality. method: in this pilot study a total number of 30 patients on maintenance haemodialysis will be enrolled. the investigator will examine the course of fgf-23 and pth levels during a single hemodialysis session. in addition, the t-50 time, a novel non-traditional cardiovascular risk factor as well as further parameters of shpt, such as serum calcium (sca), phosphate (p), 25-hydroxy-vitamin d (25(oh)d) and 1,25 dihydroxy-vitamin d (1,25(oh)2d) will be assessed. hypothesis and specific aims: the major end point of the study is the level of fgf-23 and pth at three points during hemodialysis treatment. as secondary end points the t-50 calcification propensity and further parameters of shpt, as well as the correlation between these parameters will be measured. hemodialysis is classified as a kidney replacement therapy and fgf-23 and pth are partly metabolized and excreted by the kidneys. based on this the investigator hypothesize that fgf-23 and pth levels are at their highest at the beginning of dialysis and decrease during the treatment.

Eligibility criteria:
inclusion criteria: * \>18 years * hemodialysis three times a week exclusion criteria: * subject is currently enrolled or not yet completed at least 30 days since ending other investigational device or drug trial(s), or is receiving other investigational agent(s) * pregnancy * subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures

Keywords: ckd hemodialysis fgf 23 pth
software treatment for actively reducing severity of adhd - follow up

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this is an exploratory study to assess potential maintenance of clinical benefit (cognition and symptoms) following 4 weeks of at-home digital therapy in adhd children.

the study will be a blinded (investigators and outcome assessors), randomized (from parent study akili-001r), parallel group, follow-up study of the sustained effects of 4-weeks of treatment with either akl-t01 (evo multi) game-based digital therapy or akl-t09 (evo words) game-based digital therapy. the trial will consist of 4 visits: screening (to be conducted at the same time as the end-of-study visit for the parent study akili-001r), fu-day 28 visit (conducted in clinic), and fu-day 56 and fu-day 84 visits (conducted remotely via electronically captured parent reported outcomes).

Eligibility criteria:
inclusion criteria: * completed akili study akili-001r including all clinical assessments at day28 per the study protocol * ability to comply with all the testing and requirements per this protocol exclusion criteria: * participant is currently considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior as measured by c-ssrs at screening * participant has demonstrated clinically significant deterioration in functioning as assessed by pi and other study staff that would contraindicate continued participation in the follow-up study

Keywords: adhd
ambulatory prolapse surgery

Conditions: Genital Prolapse; Vaginal Floor Prolapse

Summary: day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. it provides many grounds for patient satisfaction. progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized. day-care surgery for prolapse has been little studied. the present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. the secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence. the design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the lyon hospitals board (hospices civils de lyon).


Eligibility criteria:
inclusion criteria: * stage iii or iv anterior genital prolapse (cystocele) on the pelvic organ prolapse quantification (pop-q) classification and/or vaginal floor prolapse * vaginal approach with prosthetic reinforcement planned * patient eligible for day-surgery * patient consenting to participate * informed and signed consent exclusion criteria: * interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, progressive disease, etc. * patient with ≥1 ineligibility criterion for day-surgery * impaired lower-limb range of motion preventing positioning for surgery * pregnancy, ongoing or planned during the study period * progressive or latent infection or signs of tissue necrosis on clinical examination * non-controlled diabetes (glycated hemoglobin \>8%) * treatment impacting immune response (immunomodulators), ongoing or within previous month * history of pelvic region radiation therapy, at any time * history of pelvic cancer * non-controlled progressive spinal pathology * known hypersensitivity to one of the implant components (polypropylene) * inability to understand information provided * not covered by a national health insurance scheme, prisoner or under administrative supervision.

Keywords: genital prolapse day-care management vaginal route prosthetic reinforcement
pharmacokinetics and toxicodynamics of daptomycin in bone and joint infections

Conditions: Dactinomycin Adverse Reaction; Bone and Joint Infection

Summary: the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection

daptomycin is widely used in osteoarticular infections (ioa), as an alternative to vancomycin, and recommended for this use by various learned societies including the infectious diseases society of america (idsa) in 2013. tolerance to daptomycin is generally favorable, with in particular better renal tolerance than vancomycin. however, two rare and potentially severe side effects have been described with this antibiotics: muscle toxicity and eosinophilic pneumonia.

Eligibility criteria:
inclusion criteria: * patients who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed exclusion criteria: * patients who objected to participating in the study * absence of blood dosage of daptomycin

Keywords: bone and joint infection adverse event daptomycin eosinophilic pneumonia cpk rhabdomyolysis