Kornimate/medical-research-clean huggingface dataset:
randomised controlled trial pfc versus cks total knee prostheses

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.


Eligibility criteria:
inclusion criteria: all patients on the waiting list for a tka due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma. exclusion criteria: * patient suffering from juvenile rheumatic disease * patient suffering hemophilia * patient on the waiting list for posterior stabilized tka or hinge joint. * patient who suffers from a lesion of the ligaments due to surgery * patient who is legally not capable to make decisions * patient who suffer from cancer
interoceptive exposure as a treatment option for disabling fear of pain

Conditions: Chronic Pain

Summary: the aim of this study is to investigate the use of interoceptive exposure (ie) in treatment of disabling fear of pain using a single-case series design.

the intervention interoceptive exposure (ie) is an exposure to bodily sensations used in treatment of variety of problems where body sensations are experienced as threatening. the application of ie is expected to reduce the threat value of pain and subsequently promote recovery. this study will evaluate the effects of ie and will briefly comprises of: education session explaining the rationale behind ie practice, teaching of the technique, supervised ie practice and self-monitored home practice twice daily for the period of two weeks. depending on the length of baseline (i.e. observation period before the start of intervention) the study will last between 6 and 8 weeks. daily diary, a short nine item instrument was designed to measure the pain experience (intensity and interference) and fear of pain on a daily basis. other, standard outcome measures include: pain related anxiety, pain catastrophising, pain related disability, knowledge about pain and general anxiety and depression. study participants will be recruited during routine psychology screening assessment at the pain clinic at st james' hospital. this study will recruit from clinical psychology waiting list patients.

Eligibility criteria:
inclusion criteria: * presence of chronic pain (i.e. pain present for minimum of 3 months following tissue damage) * 18 years or older * capacity to give informed consent * appropriate diagnostic investigations in other specialties as appropriate have been exhausted and first line interventions, like analgesia, have been tried. * participant has appropriate expectations regarding psychological treatment, i.e. does not expect injections etc. exclusion criteria: * insufficient understanding of english or additional needs which mean the potential participant is unable to complete questionnaires independently. this is because the research project does not have the resources to make significant adaptations to the materials i.e. translation into another language or into braille. * unable to meet the demands of the study (i.e. daily recording of data, daily practice of ie, coming for sessions to st james' hospital).
effects of rehabilitation on muscle fibre composition and capillaries in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients with chronic obstructive pulmonary disease (copd). the aim of our study is to show a potential change in muscle fibre composition and in the amount of capillaries in quadriceps muscle from pre tob post 3-week rehabilitation. pulmonary rehabilitation includes standardised exercise training, e.g. cycling and strength training for major muscle groups.


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease * fev1%pred. \< 50% exclusion criteria: * acute exacerbation * exacerbation in the last 4 weeks

Keywords: muscle fibre capillary rehabilitation exercise training
duration of music interventions and pain tolerance (dominant)

Conditions: Pain, Acute

Summary: this study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance.

music interventions reduce perioperative pain and anxiety. however, it is yet unclear how long music needs to be presented in order to have an effect. therefore, the investigators would like to propose a pilot randomized controlled trial in order to investigate the optimal duration of musical interventions. the main objective of this study is to investigate the effect of different durations of music interventions on pain tolerance (expressed in amperage). secondary objectives are to investigate the effects of music duration on heart rate variability (expressed in milliseconds) and subjective measurements of emotions, anxiety and pain. healthy volunteers (age ≥18 years) will be included, and the study will take place at the outpatient clinic of the center of pain medicine, erasmus medical center, rotterdam.

Eligibility criteria:
inclusion criteria: * between 18 and 64 years of age * sufficient knowledge of the dutch language to understand the study documents (in the judgement of the attending physician or researcher) * provision of written informed consent by subject exclusion criteria: * significant hearing impairment * current complaints of tinnitus * current use of analgesic medication * presence of acute or chronic pain * history of cardiac disease or arrhythmias * current treatment by a medical specialist or general practitioner * professional musician or singer (practicing in average \>1 hour each day) * pregnancy

Keywords: music-induced analgesia
tdcs to decrease opioid relapse (ug3)

Conditions: Opioid Dependence; Craving

Summary: in the current proposal, the investigators will measure behavioral and brain responses following transcranial direct current stimulation (tdcs) to the dorsolateral prefrontal cortex (dlpfc) (anode on right dlpfc, cathode on the left dlpfc) delivered during cognitive control network (ccn) priming. participants with opioid dependence, in the first month of prescribed buprenorphine or methadone, will be assessed twice using electroencephalographic (eeg), once prior to tdcs+ccn priming and again at the completion of 5 sessions of tdcs+ccn priming (one week later). eeg will provide validation of expected changes in these networks following tdcs stimulation of the dlpfc.

investigators propose to use eeg to examine oscillatory brain changes as well as self-reported craving before and after administration of five sessions of tdcs+cognitive control network (ccn) priming stimulation vs. sham tdcs+ccn priming (randomized control trial) in 60 opioid dependent participants who recently initiated buprenorphine or methadone. participants in the first month of prescribed buprenorphine or methadone will be assessed eeg, once prior to tdcs and again one week later after completion of 5 sessions of tdcs+ccn priming. eeg will be expected to provide 1) validation of expected network and oscillatory changes from tdcs-targeting and 2) an effect size for dlpfc vs sham stimulation. go/no go criteria for the ug3 phase will be demonstration of enhanced frontal theta power during a wm task and greater change (at least 10% difference between conditions, controlling for baseline craving) in subjective craving following the tdcs+ccn priming intervention compared to sham tdcs+ccn priming.

Eligibility criteria:
inclusion criteria: * current opioid dependence * between 21-50 years of age * recent initiation of buprenorphine or methadone (\<30 days) exclusion criteria: * current criteria for a dsm-v diagnosis of bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder * current suicidality * evidence of neurocognitive dysfunction * contraindications for tdcs (e.g seizure disorder) * probation/parole requirements or an upcoming move that might interfere with protocol participation * planning to terminate buprenorphine in less than 3 months * scalp lesions near the tdcs electrode sites
delivery room skin-to-skin study

Conditions: Very Low Birthweight Infants; Mother Child Interaction; Preterm Infant

Summary: the first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. we hypothesize that promoting skin-to-skin contact of vlbw infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. we also hypothesize that reactivity of hpa axis and molecular patterns of stress signaling pathways differ in preterm infant with or without ssc after birth.


Eligibility criteria:
inclusion criteria: * birthweight \<1500g, first child, informed consent exclusion criteria: * multiples, malformation

Keywords: reactivity of hpa axis
a phase 1b/2a study of sc hanferon™ in combination with ribavirin in treatment-naïve subjects with genotype 1 hepatitis c

Conditions: Chronic Hepatitis C Infection; Genotype 1

Summary: this is an open-label, randomized, safety, tolerability, dose-finding, pk/pd, and preliminary efficacy study of subcutaneous hanferon™ in combination with ribavirin(rbv) in treatment-naïve subjects with genotype 1 hepatitis c.

the primary objective of this study is to evaluate the safety and tolerability of ascending doses of hanferon™ in combination with ribavirin (rbv). the secondary objective of this study is to define the pk and pd of ascending doses of hanferon™ in combination with ribavirin(rbv). the exploratory objective of this study is to make a preliminary assessment of hanferon™ efficacy in combination with ribavirin(rbv).

Eligibility criteria:
inclusion criteria: * diagnosis of chronic hepatitis c genotype 1a or 1b * male or female aged 18 to 65 years, inclusive * compensated liver disease without evidence of cirrhosis * no evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome * no history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies * stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia exclusion criteria: * history of previous treatment of hepatitis c * currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis * history or presence of chronic liver disease * history of drug or alcohol abuse within the past year * evidence of active illicit drug use * clinically significant abnormal electrocardiogram (ecg) or rhythm strip * female subject who has a positive urine pregnancy test or who is lactating

Keywords: hepatitis c hcv interferon hanferon
effect of high-calcium milk and weight-bearing exercise on bone mineral status of pre-pubertal girls

Conditions: Osteoporosis

Summary: osteoporosis has been described as a paediatric disease with a geriatric outcome. this is because bone mass is acquired during youth and is progressively lost later in life, without symptom or pain, until a fracture occurs. the proper management of osteoporosis includes improving bone mineral content in the first two decades of life so that reserves are built up before bone loss ensues. the investigators aim to determine the effect of a 10-month school-based provision of high-calcium milk and weight-bearing exercise program on the bone mineral status among prepubertal girls. the investigators' study is novel since it seeks to determine the effect of these interventions in girls, whose overall risks are much higher for osteoporosis later in life, and in a developing country population whose calcium intakes are more likely to be depleted. the investigators hypothesize that provision of either high-calcium milk or weight-bearing exercises will improve bone mineral density among prepubertal girls but that the bone accrual will be greater among those with both interventions. in addition, the investigators hypothesize that the changes will be more marked among those whose calcium intakes are lower. this study will use a two-by-two factorial design of 1) high-calcium milk (1000 mg/day) vs. placebo (115 mg/day) and 2) weight-bearing exercises (a total of 90 to 150 minutes per week divided into 3 to 5 schooldays) vs. no-exercise (passive activities) in a randomized controlled trial, for a total of 4 intervention groups: calcium+exercise, placebo+exercise, calcium+no exercise, placebo+no exercise. the study will be conducted among 80 prepubertal girls (on tanner stage 1), aged 7-9 years and enrolled in one primary school in one of the metropolitan cities in the philippines with an institution or a hospital with a lunar prodigy central dual-energy x-ray absorptiometry (dexa) machine. osteoporosis has no treatment. the problem will continue to become burdensome in the future since population aging per se will increase the risk and incidence of fractures. understanding the relationship between calcium and exercise is important since the greatest benefit is in the paediatric age range. the study results could provide information on a workable intervention that promotes the multiple health benefits of both exercise and high-calcium milk to young children.


Eligibility criteria:
inclusion criteria: * pre-pubertal girls on tanner stage 1 * enrolled in study school * no diagnosed disorders * not taking medications that affects bone metabolism or weight-bearing exercise exclusion criteria: * not meeting the inclusion criteria

Keywords: osteoporosis calcium weight-bearing exercise bone mass prepubertal girls
clinical evaluation of a wearable technology for the diagnosis of sleep apnoea

Conditions: Obstructive Sleep Apnea

Summary: this trial will aim to test a new wearable device for the diagnosis of sleep apnoea.

this clinical trial will test a new wearable device for the diagnosis of sleep apnoea against multi-channel polygraphy and polysomnography.

Eligibility criteria:
inclusion criteria: * patients who have been referred to a sleep clinic due to suspicion of sleep apnoea. * patients between the age of 18 yo and 80 yo exclusion criteria: * who are not fluent in spanish, or who have special communication needs. * known allergy to the adhesive dressing. * patients with physical or mental impairments who would not be able to use the new technology on their own. * patients with very loose/saggy skin in the neck area which would unavoidably result on acupebble swinging if moving the neck. * patients with pacemakers or who have any type of implanted electronic device
pre-approval single-patient expanded access for elranatamab (pf-06863135)

Conditions: Multiple Myeloma

Summary: provide pre-approval single-patient expanded access (compassionate use) of elranatamab for patients with relapsed/refractory multiple myeloma

in expanded access, treating physicians are the sponsors expanded access requests from treating physicians should be directed to www.pfizercares.com availability will depend on location.

Eligibility criteria:
must have relapsed/refractory multiple myeloma (rrmm) and be refractory to at least one immunomodulatory drug, one proteasome inhibitor and one anti-cd38 antibody. must have evidence of disease progression after last therapy. must have exhausted all available treatment options accessible as local standard of care and not be eligible for participation in any ongoing clinical trial. additional eligibility criteria may be required.

Keywords: refractory relapsed
effect of chronic supplementation of l-arginine in the muscular performance

Conditions: Muscular Fatigue

Summary: the primary purpose of this study is to evaluate the effect of oral administration of l-arginine in the muscular fatigue of the quadriceps, expressed in terms of the fatigue resistance factor (frf). the secondary purpose of this study is to evaluate the effect of oral administration of l-arginine in the muscular force the quadriceps.


Eligibility criteria:
inclusion criteria: healthy young adults for both sex; age between 20 and 55 years; slight or moderate physical activity, 30 minutes per day, at least 3 times a week; exclusion criteria: cardiac or pulmonary disease; previous history of knee surgery or skeletal muscular dysfunctions in hip, knee or ankle joints; athletic person (intensive anaerobic activity); none practiced of physical activity regularly; medications usage the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
blood sampling through peripheral venous catheter in infants

Conditions: Pain

Summary: we hypothesize that peripheral venous catheter used for fluid administration can replace venipuncture blood sampling for selected basic analytes and thus reduce pain in infants under 2 years of age.

multiple venipunctures in hospitalized children result in physical and emotional distress. recently, we have found that blood sampling via peripheral venous catheter used for fluid administration in children significantly reduces pain and, except for glucose, can replace venipuncture for determining complete blood count and basic chemistry analytics, including white and red blood cell counts, hemoglobin and hematocrit levels, mean corpuscular volume, mean corpuscular hemoglobin level, red blood cell distribution width, platelet count, mean platelet volume, and sodium, potassium, chloride, and urea levels (berger-achituv s, budde-schwartzman b. ellis mh, shenkman z. erez i. blood sampling through peripheral venous catheters for selected basic analytes in children. pediatrics. in press). the goal of this study is to investigate whether blood sampling via peripheral venous catheter used for fluid administration can significantly reduces pain and replace venipuncture for determining complete blood count and basic chemistry analytics in infants under 2 years of age.

Eligibility criteria:
inclusion criteria: * infants under 2 years of age. * only hemodynamically stable infants. * infants with peripheral venous catheter present for less than 72 hours. * at least 20 ml of fluids have been infused intravenously at the time of blood sampling. exclusion criteria: * infants with signs of catheter-related thrombophlebitis.

Keywords: blood sampling venipuncture peripheral venous catheter complete blood count basic chemistry hemolysis peripheral venous catheter replaces venipuncture. peripheral venous catheter blood sampling reduces pain.
improving low bone mass with vibration therapy in adolescent idiopathic scoliosis (ais)

Conditions: Scoliosis; Bone Diseases, Metabolic

Summary: this is a prospective randomized controlled trial investigating the effect of vibration therapy on bone mineral density (bmd) and bone quality in ais subjects suffering from osteopenia (low bone mass).

scoliosis is a three-dimensional spinal deformity and ais is the commonest with a high prevalence of 2-4 % in the general population. as many as 30% of ais subjects also suffer from osteopenia which can persist and result in serious health problems later in life including vertebral collapse, fragility fractures, decreased quality of life and even mortality. in spite of this, a safe, effective and evidence-based treatment protocol for ais-related osteopenia is not available. it remains uncertain how effective dietary advices, physical activity, calcium and vitamin d supplements are in this regard. on the other hand, low-magnitude high-frequency vibration therapy was shown to be effective in increasing bone mass both in animal models and in clinical trials involving elderly subjects. ais-related osteopenia may have a different clinical behaviour. in addition, the in-vivo effect on bone quality has never been studied. we plan to carry out a scientific clinical study on the effect of vibration therapy on skeletally mature female ais subjects with osteopenia. they are randomly allocated to either the treatment or the control group. bmd, bone micro-architectures are assessed to delineate whether vibration therapy has any therapeutic effect on improving low bone mass in osteopenic ais subjects.

Eligibility criteria:
inclusion criteria: * 15 to 25 year-old female patients suffering from clinically and radiologically diagnosed ais * more than 18 months post-menarche and risser's sign equal to or greater than 4, and fusion of epiphyseal plate of all phalanges and metacarpals of the left hand and wrist. * the cobb's angle of the major structural curve is between 10 to 50 degrees (inclusive) * z-score bmd of less than -1 exclusion criteria: * medical or musculoskeletal conditions that contraindicate or prevent the patients from receiving vibration therapy * subjects who are not willing to comply with the treatment protocol * subjects suffering from any medical conditions that affect bone metabolism such as hyperparathyroidism, hyperthyroidism, osteomalacia, acute or chronic renal or liver disease * treatment with medication that affects bone metabolism such as bisphosphonate, steroid. * pregnancy * history of spinal operation done for scoliosis * smokers or drinkers

Keywords: adolescent idiopathic scoliosis ais vibration therapy low bone mass osteopenia
effects of task-oriented training in individuals with stroke

Conditions: Stroke

Summary: the purpose of this study is to investigate the effects of task-oriented training on balance,functional mobility,walking, activities of daily living and quality of life in individuals with stroke.

eligible participants will be randomized to task-oriented group or control group.control group will receive conventional therapy generally consisted of neurophysiological approaches for 6 weeks 5 times a week for 1 hour per session.task-oriented group will receive conventional therapy and task-oriented training for 6 weeks 5 times a week 1,5 hours per session.each participant will be assessed before and after the 6 weeks of treatment.

Eligibility criteria:
inclusion criteria: * modified rankin score between 0-3 * having a stroke for the first time * at least 1 month has passed since the stroke * able to walk 10 m with or without assistance * having a mini mental test score of 24 and above * volunteering to participate in the study * being fluent in turkish language exclusion criteria: * having an additional neurological disease other than stroke * having an additional disease that prevents mobility * having a condition that prevents you from exercising * receiving an existing additional medical treatment for spasticity treatment * having a history of multiple strokes * having severe visual problems post stoke

Keywords: stroke tas-oriented training balance walking mobility activities of daily living quality of life