Kornimate/medical-research-clean huggingface dataset:
randomized controlled trial of dynamic balance training in people with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: there is a high prevalence of falls in those with knee osteoarthritis (oa) compared to healthy older adults. balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee oa. there is a lack of research guiding treatment for balance deficits in knee oa, with interventions aimed at improving balance deficits in those with knee oa having mixed results. targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function. if results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee oa population and improve quality of life. the purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee oa. this will be a randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: * age 50 - 80 years (to meet the american college of rheumatology clinical definition of oa) * radiographically confirmed knee oa in the medial compartment of the tibiofemoral joint * predominance of pain/tenderness over the medial (inside) region of the knee exclusion criteria: * articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial * inflammatory arthritic condition * history of knee or hip replacement surgery * recent use of corticosteroids (oral or via injection, within last 6 months) * pain originating predominantly from the patellofemoral joint * inability to ambulate without a gait aid * non-english speaking * recent (within 6 months) arthroscopic knee surgery * significant hip or back pain (limits the ability to perform the testing) * neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, parkinson's, heart attack, multiple sclerosis, fibromyalgia)

Keywords: balance knee osteoarthritis physical function
cyclosporine a in shockable out-of-hospital cardiac arrest resuscitation

Conditions: Shockable Out of Hospital Cardiac Arrest

Summary: cardiac arrest (ca) is a public health problem in industrialized countries. the prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors. the objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable ca. 520 patients with ca will be entered into a multicentre, randomized, placebo-controlled study. they will receive one single injection of cyclosporine (or placebo) prior to resuscitation. the incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of n20 wave or absent motor response or extension to the nociceptive stimulation...) will be assessed 7 days after ca.


Eligibility criteria:
inclusion criteria: * witnessed out-of-hospital cardiac arrest * shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia) exclusion criteria: * evidence of trauma * evidence of pregnancy * duration of no flow more than 30 minutes * rapidly fatal underlying disease * allergy to cyclosporin a

Keywords: cardiac arrest shockable cyclosporine
18f-fluorocholine for the detection of parathyroid adenomas

Conditions: Hyperparathyroidism, Primary

Summary: the investigators are studying the ability of f18 labeled fluorocholine pet to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.


Eligibility criteria:
inclusion criteria: * biochemically proven hyperparathyroidism and an indication for surgery * age \>= 13 years old * karnofsky performance status of \> 50 (or eastern cooperative oncology group (ecog)/world health organization (who) equivalent). * ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: * patients exceeding the weight limitations of the scanner or are not able to enter the bore of the pet scanner due to bmi. * inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). * inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.). * pregnancy.

Keywords: positron emission tomography
efficacy and tolerability of the apd treatment in paed patients

Conditions: Renal Failure Acute Chronic

Summary: the silencia pd (peritoneal dialysis) cycler offers a pediatric (paed) mode with advanced features such as time and volume optimization (tavo), supporting precise and individualized treatment. this study evaluates the efficacy and tolerability of automated peritoneal dialysis (apd) using the silencia pd cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 ml. the primary objective is to determine whether patients achieve a total weekly kt/vurea ≥ 1.8.


Eligibility criteria:
inclusion criteria: * informed consent signed and dated by legal representative and investigator/authorized physician * the minors have received the information referred to in article 63(2) mdr in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children * the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in article 63(2) mdr to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator * patients with renal failure treated or planned to be treated with apd * body weight ≤ 20 kg * ability to understand the nature and requirements of the study exclusion criteria: * any conditions which could interfere with the patient's ability to comply with the study * patient or legal representative is not able to give informed consent according to european medical device regulation and corresponding national regulations * participation in an interventional clinical study during the preceding 30 days * previous participation in the same study * life expectancy \< 3 months * patients who suffer from peritonitis/exit site infection during the last 4 weeks

Keywords: automated peritoneal dialysis paedriatic patients kt/v ultrafiltration chronic kidney disease
examination of the effectiveness of diffusion weighted magnetic resonance imaging for identifying poor prognosis in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: diffusion weighted imaging (dwi) mri will assist in differentiating poor prognosis bone oedema more effectively than traditional t2 weighted mri in patients with early rheumatoid arthritis (ra).

assess dwi mri in patients with early rheumatoid arthritis to determine whether the mri method will assist in differentiating poor prognosis bone oedema more effectively than traditional t2 weighted mri. aim 1: to compare dwi mri with t2 weighted mri for the discrimination of different types of bone oedema lesions in patients with early ra. aim 2: to examine the association between the presence of different types of bone oedema lesions detected on dwi mri and t2 weighted mri and the development of subsequent joint bone erosion as detected on i) mri and ii) standard plain radiographs.

Eligibility criteria:
inclusion criteria: * subject has rheumatoid arthritis as defined by the acr/eular criteria * subject is able to understand and comply with study protocol * active disease as defined by das28\> 3.0 * disease duration less than 12 months * if female, subject is either not of childbearing potential, or is of childbearing potential and is practicing an approved method of birth control throughout the study * subject is judged to be in good health as determined by the pi based upon results of medical history, laboratory profile and physical examination. * prednisone dose 10mg or less, dose stable for 28 days prior to baseline exclusion criteria: * inflammatory arthropathy other than rheumatoid arthritis * inactive disease as evidenced by das 28 crp and / or esr \< 2.5 * prednisone dose greater than 10mg within 28 days prior to baseline * intra-articular steroid within 28 days prior to baseline visit * iv methyl-prednisone within 28 days prior to baseline visit * any contra-indication to magnetic resonance imaging * permanent pacemaker * intracerebral aneurysm clip * claustrophobia to the extent that patient cannot manage mri investigations * implanted metallic device * cochlear implant
online cognitive behavioural therapy for addiction: efficacy and cost-effectiveness in a pragmatic clinical trial

Conditions: Substance Dependence

Summary: the purpose of this study is to compare the efficacy and cost-effectiveness of a computer-based training for cognitive behavioural therapy (cbt4cbt) to treatment as usual in outpatients seeking treatment for substance use disorder.

fifty-two adult outpatients seeking treatment for substance use disorder from the centre for addiction and mental health addictions program will be randomized to receive either a computer-based training for cognitive behavioural therapy or treatment as usual for eight weeks. participants will complete interviews, questionnaires, and other assessments (urine toxicology and physiological assessments) at week 0, at week 8, and at 6 month follow-up). measures will assess alcohol and drug consumption, substance use disorder symptoms and associated features, quality of life, and healthcare costs.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. fluency in english 3. understanding and willingness to comply with study requirements 4. meet diagnostic criteria for current substance use disorder 5. have used substance in the past 30 days 6. treatment-seeking for substance misuse exclusion criteria: 1. unable to read at sixth grade level 2. untreated or unstable severe psychiatric or medical disorder 3. acute suicidal or homicidal ideation

Keywords: cognitive behavioural therapy online treatment
infliximab top-down in pediatric crohn

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe pediatric crohn's disease (cd) patients.

objective: the purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe pediatric crohn's disease (cd) patients. sample size: we will include 100 (2 x 50) patients. with these numbers a difference of 60% and 85% (= 25) can be shown at a power of 80% (2-sided α 0.05; nquery advisor). study design: an international open-label randomised controlled trial study population: children (age 3-17 yrs) with new-onset, untreated, cd with moderate-to-severe disease activity intervention: patients will be randomised to either top-down ifx treatment or conventional step-up treatment. treatment arm 1: top-down ifx treatment will consist of a total of 5 ifx infusions of 5 mg/kg (ifx induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks) combined with oral azathioprine (aza) 2-3 mg/kg once daily. aza therapy will continue after the last ifx infusion to maintain remission. treatment arm 2: step-up treatment will consist of standard induction treatment by oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop. prednisolone will be combined with oral aza 2-3 mg, once daily, as maintenance treatment. main study parameters/endpoints: clinical remission at 52 weeks without need for additional ibd related therapy or surgery. secondary endpoints include clinical response, remission and mucosal healing at week 10 and 52, growth and adverse events.

Eligibility criteria:
inclusion criteria: children (age 3-17 years, both male and female) with new-onset, untreated cd with moderate-to-severe disease activity assessed by a wpcdai \>40 will be eligible for inclusion after a diagnosis of cd was made based on the porto criteria. exclusion criteria: patients with the following characteristics will be excluded: immediate need for surgery, symptomatic stenosis or stricture in the bowel due to scarring, active perianal fistulas, severe co-morbidity, severe infection such as sepsis or opportunistic infections, positive stool culture, positive clostridium difficile assay, positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy, those already started with cd specific therapy.

Keywords: crohn's disease pediatric infliximab top-down itskids
acupuncture or mbsr for patients with fatigue and ms

Conditions: Fatigue; Multiple Sclerosis

Summary: the main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.

in multiple sclerosis, fatigue is the most common clinical symptom, reported by up to 97% of patients. no successful evidence-based therapy exists so far. the main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis. we want to include 141 patients with multiple sclerosis and fatigue. participants will be randomised into three groups to compare 1) usual care, 2) usual care plus standardised acupuncture, and 3) usual care plus mindfulness-based stress reduction. treatment duration will be 12 weeks. the primary outcome is the fatigue severity scale (fss) after 12 weeks, follow-up measurement will be performed after 26 weeks. secondary outcomes include other fatigue specific parameters, other ms specific parameters, cost, and physiological, immunological and functional magnetic resonance imaging parameters.

Eligibility criteria:
inclusion criteria: * female or male * 18 to 65 years of age * able to give oral and signed written informed consent * clinical diagnosis of multiple sclerosis * fatigue in "multiple sclerosis" for at least 3 months * other stable pre-study treatment with respect to target symptom fatigue for at least 3 months before inclusion * stable immunomodulatory or immunosuppressive therapy or stable no such a therapy for at least the 3 months before inclusion * fatigue score of ≥4 on the fatigue severity scale at inclusion * patient's mental and physical ability to participate in the trial * willingness to be randomised, to attend visits, to complete questionnaires, and willingness to participate and fmri measurements exclusion criteria: * fatigue because of a malignant disease * acute relapse or cortisone therapy therapy in the last 30 days before inclusion * edss (extended disability status scale) \> 6 * fatigue specific acupuncture in the last 12 months * during the last 12 months performing of mbsr exercises learnt in the past * change of immunomodulatory or immunosuppressive therapy during the 3 months before inclusion * other new therapies are planned which could have a positive effect on fatigue (e.g. exercise, acupuncture, relaxation therapy) * for female patients: pregnancy or anticipated pregnancy during the intervention period * severe acute and or chronic disease which does not allow participation in the therapy * other limitations which do not allow participation in the therapy * alcohol or substance abuse * parallel participation in another clinical trial * bdi \> 29 * contra indications for fmri session (e.g. metal clips)

Keywords: multiple sclerosis, fatigue
high infusion rate study of immunoglobulin intravenous (human) 10% (newgam)

Conditions: Primary Immunodeficiency Disease

Summary: this was a prospective, open-label, non-controlled, non-randomized multicenter phase iii study of 2 multiple-dose intravenous newgam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study nct01012323 \[ngam-01\]) for 3 months. the primary objective of the study was to assess the safety and tolerability of high infusion rates of newgam.

patients received newgam via an infusion pump to control precise infusion rates. all newgam infusions started at a rate of 0.01 ml/kg/min (60 mg/kg/h) for the first 30 minutes followed by 0.03 ml/kg/min (180 mg/kg/h) for the next 15 minutes. if tolerated, further increments were made at predefined patterns with the following maximum rates: 0.10 ml/kg/min (600 mg/kg/h) in the first infusion; if this was tolerated, 0.12 ml/kg/min (720 mg/kg/h) in the second infusion; if this was tolerated, 0.14 ml/kg/min (840 mg/kg/h) in all subsequent infusions. if an adverse event occurred during an infusion, the rate was reduced to half the rate at which the event occurred or the infusion was interrupted until symptoms subsided. the infusion was then resumed at a rate tolerated by the patient.

Eligibility criteria:
inclusion criteria: * completion of the main study ngam-01. * at each of the last 3 infusions in the main study ngam-01, administration of newgam at the maximum infusion rate of 0.08 ml/kg/min and without the need for premedication. exclusion criteria: * any condition or circumstance that would have led to the exclusion of the subject from the ngam-01 study. * administration of any immunoglobulin infusion other than newgam between conclusion of the ngam-01 study and the beginning of the present study. * a deviation of the subject's treatment interval of more than 7 days between the last infusion of newgam in the ngam-01 study and the first infusion of newgam in the present study.

Keywords: primary immunodeficiency disease pid
the impact of oral and nasal enteral nutrition feeding quantity in stroke patients

Conditions: Stroke

Summary: the goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using intermittent oro-esophageal tube and nasogastric tube. patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. on this basis, the observation group will use intermittent oro esophageal tube for enteral nutrition support, while the control group will use nasogastric tube. researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if intermittent oro-esophageal tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to nasogastric tube

the study will last 15 days for each participant. the goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using intermittent oro-esophageal tube and nasogastric tube. patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. on this basis, the observation group will use intermittent oro esophageal tube for enteral nutrition support, while the control group will use nasogastric tube. researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if intermittent oro-esophageal tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to nasogastric tube

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for ischemic stroke . * dysphagia confirmed by videofluoroscopic swallowing study. * clear consciousness. * no history of prior stroke. * stable vital signs. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females.
evaluation of topical liposomal lidocaine and oral sucrose for treatment of pain in newborns undergoing venipuncture

Conditions: Pain

Summary: the objective of this study is to determine the relative efficacy of sucrose, liposomal lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in newborn infants.

despite the fact that modern medical practice is greatly advanced, pain is inflicted on all canadian newborn infants in the first days and months of life from blood tests, injections and cannulations designed to prevent, diagnose or manage medical conditions. procedural pain in newborn infants is a significant burden to infants, their parents, healthcare workers, and society at large. this study proposes a large randomized controlled trial to determine the optimal analgesic regimen for procedural pain using methods that can be easily implemented in clinical practice. we will study liposomal lidocaine cream and sucrose oral liquid, used alone, or together, to manage procedural pain. liposomal lidocaine is a relatively new anaesthetic formulation ideally suited for young infants due to the established role of lidocaine in neonatal clinical medicine. sucrose (sugar water) reduces pain responses and is promoted in consensus guidelines developed by pain experts. however, it is perceived by many front-line clinicians to be simply a comforting agent rather than a true analgesic. studying liposomal lidocaine and sucrose together is important since the combination may prove superior to either agent alone, and may even prevent or abolish pain from clinical procedures.

Eligibility criteria:
inclusion criteria: * healthy newborn infants * ≥ 37 weeks gestational age. exclusion criteria: * neonatal intensive care unit (nicu) admission * asphyxia, seizures * major birth defect (heart, brain, genetic syndrome) * circumcised during study * receiving analgesia/sedatives.

Keywords: pediatrics pain infants newborn screening venipuncture lidocaine sucrose
a study of three pf-05190457 formulations in healthy volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to evaluate the plasma drug concentrations of three formulations of pf-05190457 after administration of single doses to healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy males and females of non-childbearing potential between ages of 21 and 55 years, bmi of 17.5 to 30.5 kg/m\^2, and weight above 50 kg. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Keywords: phase 1 single doses biocomparison pharmacokinetics healthy volunteers