Kornimate/medical-research-clean huggingface dataset:
intradialisis physical exercise in quality of life and health

Conditions: Chronic Kidney Diseases

Summary: evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing hemodialysis.

objective of this study will be evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing on hemodialysis. this study will include to 100 people over 18 years old who are stage five of chronic kidney disease and go to hemodialysis units of bogota d.c, colombia. the ransomized controlled clinical trial to clusters, with 3 groups of intervetion and 1 control, double masking. all the participants receive information on informed consent. the study was approved by the ethics committee of the universidad del rosario

Eligibility criteria:
inclusion criteria: * include participants with stage five of chronic kidney disease, * people over 18 years old. * their participation is voluntary and their have signed the informed consent form. * persons that are undergoing hemodialysis for at least 3 months. * persons have ability to do exercise protocols. * persons have the approval by nephrologist doctor and deportologist for to do the study according to the results of initial medical assessment. exclusion criteria: * surgical intervention to least 6 months. * skeletal limitations that affect exercise performance. * psychiatric disorders and psychological such as depression, anxiety that could be affect participation of the study. * body mass index greater than 30 kg/m2 and not less than 18.5 kg/m2. * hemodialysis catheter dysfunction or infection as well as participation in home exercise programs.

Keywords: chronic kidney disease health indicators quality of life hemodialysis peritoneal dialysis cardiovascular exercise resistance exercise
a study to assess the efficacy, safety, and pharmacokinetics of tb006 in participants with acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: this multi-center, randomized, parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of tb006 in participants with an acute ischemic stroke (ais) event with 57 days of treatment.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18 and 40 kilograms per meters squared (kg/m\^2), inclusive * clinical diagnosis of ais in anterior circulation, supported by evidence of a new stroke on acute brain computed tomography (ct) or magnetic resonance imaging (mri) consistent with the clinical diagnosis. * able to be randomized and dosed within 7 days of index stroke event. the last known awake time will be used for participants whose stoke occurred during sleep. * national institute of health stroke scale total score of 7 to 21, inclusive * participants may have received standard of care therapy including recombinant tissue plasminogen activator (r-tpa), thrombectomy, mannitol, hypertonic saline, and other treatments per local guidelines as determined by the investigator. participants who have received r-tpa within the first day of their stroke event are eligible. however, study drug administration must begin more than 24 hours following r-tpa administration. exclusion criteria: * evidence of severe stroke on imaging (e.g., sulcal effacement or blurring of gray-white junction in greater than 1/3 of middle cerebral artery \[mca\] territory, alberta stroke program early ct \[aspect\] score of 0 to 4 based on head ct, acute infarct volume on mri diffusion weighed imaging ≥70 ml based on acute imaging studies performed under the standard of care * lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care * evidence of seizure at the onset of index stroke * evidence of acute myocardial infarction (mi) at baseline, including any of the following: 1. acute st elevation mi; 2. acute decompensated heart failure, or new york heart association class iii/iv heart failure; 3. admission for an acute coronary syndrome, mi, cardiac arrest, or non-voluntary coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months. 4. qt interval corrected using bazett's formula (qtcb) \>520 milliseconds (msec). * evidence of acute intracranial or subarachnoid hemorrhage or evidence of active bleeding based on acute brain ct or mri performed under the standard of care. however, petechial hemorrhages of ≤ 1 centimeter (cm) are not exclusionary. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: acute ischemic stroke (ais) tb006 stroke efficacy safety pharmacokinetics ischemia
airway vascular lesions

Conditions: Hemangiomas; Venous Malformations; Lymphatic Malformations

Summary: controversy exists in the treatment of airway hemangiomas ranging from tracheotomy, various lasers, to open removal, none of which have proven to be a gold standard. venous malformations of the airway are difficult to treat and also require laser therapy or open removal and often repeated treatments are required. similarly airway lymphatic malformations can require multiple treatment modalities as well as multiple procedures and are infrequently eradicated when extensive. new uses for various lasers and differing treatment protocols are frequently developed. review of the treatment modalities and efficacy of these methods is required. the goal of this research is to determine protocols for treatment of airway vascular malformation and to evaluate our results from treatment of these lesions.


Eligibility criteria:
inclusion criteria: * airway vascular lesion exclusion criteria: * none at this time

Keywords: airway hemangiomas venous malformations lymphatic malformations
the improved ballet shoe: a study on the effect of an orthosis on pain during dancing on pointe shoes

Conditions: Ballet Dancers

Summary: an orthosis in the ballet shoe to see if pain reduction during dancing on pointes will decrease. one group of pre-preprofessional ballet dancers will receive an orthosis and will train during four weeks with it. the other group without a orthosis will be the control group.


Eligibility criteria:
inclusion criteria: * girls on preprofessional ballet schools with a minimum of 30 minutes professional training a week; * 12 to 18 years old * pain during dancing on pointes exclusion criteria: * experience with wearing a orthosis in their ballet shoe

Keywords: ballet shoe orthosis pain
safety and immunogenicity study of a booster dose of gsk biologicals' 10-valent pneumococcal conjugate vaccine

Conditions: Infections, Streptococcal

Summary: this study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of mmrv vaccine at 12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate vaccine in study 105553. antibody persistence will be evaluated at 8-10 months after completion of the 3-dose immunization course in study 105553. the immunogenicity, safety and reactogenicity of the 1st and 2nd dose of mmrv vaccine will also be evaluated when co-admin with the pneumococcal conjugate vaccine between 12-16 months of age. the study has 3 groups. * the 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose of mmrv vaccine at 12-14 mo of age and the booster dose of infanrix hexa™+ 2nd dose of mmrv vaccine at 14-16 mo of age. * the 2nd group will receive the booster dose of infanrix hexa™ + 1st dose of mmrv vaccine at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of mmrv vaccine at 14-16 mo of age. * the 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the booster dose of infanrix hexa™ at 12-14 mo. subjects will be offered one dose of priorix™ and varilrix™ at 14-16 mo of age, outside the study.


Eligibility criteria:
inclusion criteria: * a healthy male or female, 12-14 months of age at the time of first vaccination, who received at least one dose of pneumococcal conjugate vaccine during study 105553 and with written informed consent obtained from the parent/guardian of the subject. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up). * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and ending 42-56 days after the last dose of vaccine(s). * administration of any additional pneumococcal vaccine since end of study 105553. * previous vaccination against measles, mumps, rubella and/or varicella. history of, or intercurrent measles, mumps, rubella and/or varicella/zoster diseases. * known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to study start. * immunosuppressive or immunodeficient condition. * a history of seizures or neurological disease.

Keywords: streptococcus pneumonia, pneumococcal conjugate vaccine
nasal versus venous lorazepam for control of acute seizures in children

Conditions: Status Epilepticus; Seizures

Summary: status epilepticus (se) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive se. lorazepam is the standard of care for control of se when administered by intra-venous (iv) route. the investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. in resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. alternate routes of administration, if shown equivalent to conventional iv route, will be very useful in such settings or for out of hospital management of seizures in children.


Eligibility criteria:
inclusion criteria: * children presenting convulsing to the pediatric emergency or developing seizure while in casualty * age 6-14 years exclusion criteria: * known hypersensitivity to any benzodiazepine * child has received any parenteral anti-convulsant within 1 hr prior to enrollment * presence of severe cardio-respiratory compromise or cardiac arrhythmias * presence of upper respiratory tract infection * presence of basal skull fracture causing cerebro-spinal fluid (csf) rhinorrhea

Keywords: seizures status epilepticus lorazepam intra-nasal
recurrent carotid stenosis

Conditions: Cardiovascular Diseases; Carotid Stenosis; Cerebrovascular Disorders; Heart Diseases; Vascular Diseases

Summary: to determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.

background: following endarterectomy, platelets adhere and aggregate on the endarterectomized surface and release platelet-derived growth factor which induces smooth muscle cell migration and proliferation which may result in restenosis. many patients had been treated with aspirin and dipyridamole, but not in a controlled trial. the recurrent carotid stenosis study established whether antiplatelet therapy was beneficial in the prevention of recurrent carotid artery stenosis. design narrative: randomized, double-blind. eighty-three patients (90 endarterectomies) were randomly assigned to receive 325 mg of oral aspirin plus 75 mg of dipyridamole, beginning 12 hours pre-operatively, followed by a second dose administered within eight hours after the operation, and given three times daily thereafter for one year. eighty patients (85 endarterectomies) received placebo. after the adequacy of the surgical procedure was confirmed by intraoperative angiography, restenosis at the endarterectomy sites was evaluated using serial duplex ultrasound before hospital discharge and at three-month intervals postoperatively for one year.

Eligibility criteria:
men and women who had recently undergone carotid endarterectomy.
brain ion homeostasis, lithium and bipolar disorder

Conditions: Healthy; Bipolar Disorder

Summary: in this project, investigators intend to carry out the first simultaneous, in vivo, imaging study of lithium content and sodium ion homeostasis in the brain of bipolar disorder (bpd) patients under lithium therapy.

the purpose of this study is to validate a new method for the measurement of the amount of lithium (also known as lithium concentration) in the brain of subjects undergoing lithium treatment for bipolar disorder. the method involves the use of magnetic resonance imaging (mri) and spectroscopy (mrs) techniques. these are non-invasive techniques, with no known harmful effects, that allow investigators to measure the amount of lithium in an individual's brain. there will be no contrast dye used in this study.

Eligibility criteria:
inclusion criteria: * psychiatrically stable patients (diagnosed according to the diagnostic and statistical manual, dsm-iv, criteria) * on steady state serum lithium levels (0.8-1.2meq/l) exclusion criteria: * subjects who have a history of head trauma * subjects who have a contraindication for an mri exam, including a claustrophobia, surgical or vascular implants, pregnancy, pacemakers, neurostimulators, history of metal in the eyes, and orthodontia or extensive bridgework (with have a particular impact on gradient echo imaging).
a phase 2 study of intravitreal avd-104 in diabetic macular edema

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Summary: a phase 2 study to determine the safety and preliminary efficacy of intravitreal injections of avd-104, a novel glyco-mimetic nanoparticle, in reducing macular edema associated with diabetic retinopathy.

the primary objective is to evaluate the tolerability and treatment effect of intravitreal injections (ivt) of avd-104 in participants with diabetic macular edema (dme). participants will receive either three intravitreal injections of low-dose avd-104 (1.0 mg) each 28 days apart or two intravitreal injections of avd-104 at a high-dose (2.0 mg) 56 days apart. serial optical coherence tomography (oct), ultra wide-field fluorescein angiography, and oct-angiography (oct-a) will be performed to evaluate the treatment effect on central subfield thickness (cst) and areas of non-perfusion. all participants will be followed-up for safety until day 84. there will be a planned enrollment up to 30 participants.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus (type 1 or 2), as defined by the world health organization and/or american diabetes association * decreased visual acuity (va) due to dme, with bcva letter score of 75-20 letters on etdrs-like charts (20/32-20/320 snellen equivalent) * dme represented by macular thickening on sd-oct involving the center of the macula: cst ≥325 μm exclusion criteria: * any ivt anti-vascular endothelial growth factor (vegf) treatment within 3 months before randomization * any history of pan-retinal photocoagulation (prp) treatment * any use of iluvien® (alimera sciences, inc., alpharetta, ga) in the last 3 years; or ozurdex® (abbvie, chicago, il) or xipere (bausch \& lomb, vaughan, ontario, canada) in the last 6 months * history of macular laser photocoagulation * any signs of high-risk proliferative diabetic retinopathy (pdr)
ultra-low dose contrast for endovascular procedures

Conditions: Renal Impairment; Limb Ischemia, Critical

Summary: the purpose of this protocol is to study the safety and feasibility of using ultra-low dose iodinated contrast agent for infrainguinal endovascular revascularization procedures in patients with chronic limb-threatening lower limb ischemia (clti) and impaired renal function, in the new angiography suite of our department.

prospective, single-center observational study of patients with clti and renal failure but not on dialysis (egfr \<60ml/minute/1.73m2, renal disease stages 2-4), who are scheduled to undergo endovascular revascularization procedures of the lower limb arteries. the procedures will be performed on the new angiograph of the interventional radiology unit (philips azurion 7 b20/15 biplane) and the contrast administration protocol will include 1:9 or 2:9 dilutions of iso-osmotic iodinated contrast agent (visipaque 320mg/ml) with saline, with the aim of administering the minimum possible amount for the safe and effective performance of the procedure (as low as possible; alara).

Eligibility criteria:
inclusion criteria: * clti * prescheduled infrainguinal revascularization procedure * renal disease stage 2-4 (egfr \<60ml/minute/1.73m2) * adequate pre- and post-procedural hydration protocol exclusion criteria: * inadequate pre- and post-procedural hydration protocol * end-stage renal disease/ dialysis * egfr \>60ml/minute/1.73m2) * endovascular treatment of iliac artery steno-oclussive disease * allergy to contrast media

Keywords: endovascular procedures angioplasty stenting acute kidney injury
effects of limicol on ldl-cholesterol

Conditions: Hypercholesteremia

Summary: the principal objective of this study is to investigate the effects of a novel food supplement (limicol) on ldl-cholesterol levels in healthy subjects with moderate hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * about 18 to 55 years (inclusive) * subject has a stable weight for at least three months before the start of the study * subject able and willing to comply with the protocol and agreeing to give their consent in writing * subject affiliated with a social security scheme * subject willing to be included in the national register of volunteers who lend themselves to biomedical research

Keywords: delivery of health care cholesterol ldl-cholesterol coronary artery disease red yeast rice plants extract cholesterol excess
brain boost program to improve cognitive function in people with systemic sclerosis

Conditions: Scleroderma

Summary: the purpose of this study is to examine whether an 8-week online educational group-based program tailored to people with systemic sclerosis can help improve cognitive function and well-being. the study team hypothesize that participants that receive the intervention will have better improvements immediately after treatment at week 8 in all cognitive function measures, non-cognitive symptoms, and self-management compared to those in the waitlist control.


Eligibility criteria:
inclusion criteria: * have physician-diagnosis of systemic sclerosis (ssc) (any subtype) * a score of ≥ 10 on the perceived deficits questionnaire * a score of ≤ 7 on the 6-item cognitive impairment test * have access to a reliable, internet-connected device (e.g. computer, smartphone, tablet) * visual acuity with correction sufficient to work on a computer, smartphone, tablet or screen * be able to read, speak, and understand english exclusion criteria: * diagnosis of dementia or head injury * other neurological disorders that might impact cognition * have major psychiatric disorder such as major depression and schizophrenia * complex, unstable health issues that would preclude full participation in the study (like a planned surgery or active cancer treatment)

Keywords: cognitive issues memory or focus problems internet connected devices online group sessions online brain games surveys
clinical study of ningmitai capsule on promoting the passage of residual fragments after ureteroscopic lithotripsy

Conditions: Ureteral Calculi

Summary: objective: to observe the effect of ningmitai capsule on ureteral calculi after lithotripsy and evaluate the safety of treatment. study design: a multicenter, prospective, randomized, controlled clinical study design was adopted interventions: control group: give antibiotics or diclofenac sodium suppository as needed. ningmitai group: oral ningmitai capsule (produced by guiyang xintian pharmaceutical co., ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day. combination group (ningmitai plus tamsulosin).: tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of ningmitai group.

sample size: 230

Eligibility criteria:
inclusion criteria: 1. diagnosed as upper urinary calculi by b-ultrasound, kidney and upper bladder (kub), intravenous urogram (ivu) or computerized tomography (ct) before surgery with the ages between 20 and 70 years. 2. having ureteral residual fragments post url and the diameter more than 5mm. 3. the lithotripsy went smoothly with expected outcomes and without any ureteral perforation, mucous exfoliation, kidney or bladder injury, serious bleeding or any other complications. 4. willing and able to participate in this study and comply with all scheduled visits, treatment plans and complete the clinical observations. exclusion criteria: 1. pregnancy, severe diabetes, or renal insufficiency. 2. ureteral stricture and lower urinary tract obstruction. 3. concomitant treatment with α1-receptor antagonists, or chinese traditional medicines who can be used to relieve stranguria and expel stone, or any other treatment that might interference the efficacy evaluation. 4. unwilling or unable to comply with the administration regimen described in the protocol, or having an incomplete profile, hence their efficacy and safety couldn't be evaluated. 5. severe adverse events and need to withdraw from the study.

Keywords: ureteral calculi lithotripsy of ureteral calculi ningmitai capsule residual fragments
description of the organizational measures framing surgery for idiopathic scoliosis in children and adolescents - practice survey

Conditions: Practice Scope

Summary: the pediatric orthopaedic surgeon treats idiopathic scoliosis in children and adolescents using the posterior vertebral arthrodesis technique. this surgery is considered "heavy" by the child and families while it is intended for a healthy population. through this study to take stock of the measures governing idiopathic scoliosis surgery (pre-operative, intra-operative and post-operative) within the various pediatric orthopedic surgery departments on the french national territory.

the goal is to measure the interest of harmonizing the preparation of orthopedic surgery for idiopathic scoliosis in children and adolescents by implementing a eras (enhanced rehabilitation after surgery) protocol nationwide.

Eligibility criteria:
inclusion criteria: * paediatric orthopaedic surgeons in the national territory who routinely treat idiopathic scoliosis in children and adolescents and who are members of the société française d'orthopédie pédiatrique (sofop) exclusion criteria: * refusal

Keywords: pediatric orthopaedic surgeon idiopathic scoliosis pediatric enhanced rehabilitation after surgery (eras) posterior vertebral arthrodesis