Kornimate/medical-research-clean huggingface dataset:
virtual reality during ultrasound examination of women with endometriosis

Conditions: Chronic Pain; Pelvic Pain; Endometriosis

Summary: to evaluate the effectiveness of vr as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.

a prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between april to august 2020. overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of vr (study group) or with standard treatment (control group). the primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (pr) and respiratory rate (rr). pain and anxiety outcomes were measured as numeric rating scores.

Eligibility criteria:
inclusion criteria: * patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery. exclusion criteria: * women who reported the use of analgesia 6 hours prior to the procedure
a registry of participants with prostate cancer in asia

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to document prostate cancer (pc) management including diagnosis, prognosis, treatment, and care in real-world practice.

this is a multicenter (when more than one hospital or medical school team work on a medical research study), prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), longitudinal, observational registry (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions \[as in an interventional study\])of pc participants. the following 3 participant cohorts will be enrolled: high-risk localized pc, non-metastatic biochemically recurrent pc, and metastatic pc. this is an observational study and treatment decisions and clinical management of participants will follow routine clinical practice. medical care given to participants will not be influenced by participation in the study. enrolled participants will be prospectively followed throughout their course of treatment, during which data on pc treatment, clinical progression, and outcomes (including death) will be collected. at the end of registry medical resource utilization (mru) will also be collected. the maximum observational period will be 5 years. safety will be monitored throughout the study for participants being treated with jnj products.

Eligibility criteria:
inclusion criteria: * male aged 21 years or older * documented diagnosis of pc with either: high-risk localized pc; non-metastatic, biochemically recurrent pc; metastatic pc * signed participation agreement/informed consent form (icf) by the patient or a legally acceptable representative * agree to be followed-up for pc per routine clinical care exclusion criteria: * no specific exclusion criteria's were defined

Keywords: prostatic neoplasms non-interventional observational
safety and efficacy study of igf-1 in duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to determine whether igf-1 therapy improves or preserves muscle function in duchenne muscular dystrophy (dmd).

detailed description: dmd is a progressive degenerative muscle disorder for which there is no current cure. glucocorticoids (gc) are often used to improve motor function and survival but have significant side effects such as growth failure, weight gain, insulin resistance and osteoporosis. igf-1 stimulates both the proliferation and differentiation of skeletal muscle cells and is thus important for muscle repair and regeneration. igf-1 offers potential as a therapeutic agent for dmd as it may improve or preserve motor function and reduce gc side effects such as growth failure and insulin resistance.

Eligibility criteria:
inclusion criteria: * dmd diagnosed with mutational testing and/or complete absence of dystrophin on muscle biopsy * proximal pelvic girdle weakness (gower's maneuver, difficulty with arising from floor and going up steps) * male * age \> 5 years of age * bone maturation (assess by bone age x-ray): \</= 11 years of age * daily gc (prednisone or deflazacort) therapy for \> 12 months * ambulatory * informed consent * willingness and ability to comply with all protocol requirements and procedures exclusion criteria: * current or prior treatment with growth hormone or igf-1 therapy * non-ambulatory * pubertal (based on clinical tanner staging examination) * congestive cardiac failure * history of intracranial hypertension * daytime ventilatory dependence (non-invasive or tracheostomy) * concomitant therapy - any other medications/supplements that would be considered, in the opinion of the investigators, to affect muscle function, need to have been started 3 months prior to enrollment * patients enrolled in other clinical drug trials * any physical or mental conditions which may, in the investigators'opinions, render the subject unable to complete the tasks of the study appropriately * there will be no selection by ethnicity

Keywords: dmd duchenne muscular dystrophy insulin like growth factor 6 minute walk test
radiation therapy in treating patients with metastatic hormone-resistant prostate cancer receiving sipuleucel-t

Conditions: Hormone-Resistant Prostate Cancer; Metastatic Malignant Neoplasm in the Bone; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer

Summary: this pilot clinical trial studies the impact of radiation therapy on the immunogenicity of sipuleucel-t. patients with castration recurrent prostate cancer who are eligible for treatment with sipuleucel-t and who have bone metastases are eligible.

primary objectives: i. to assess whether radiation therapy (rt) increases the immunogenic potential or sipuleucel-t in participants with castration recurrent prostate cancer. ii. to assess systemic changes to the immune system and genetic changes to immune cells in participants treated by the combination of rt and sipuleucel-t. iii. to assess the induction of antigen-specific immune responses to prostatic acid phosphatase (pap), cancer/testis antigen 1b (ny-eso-1) and antigens that have proven to be released by radiation (such as, heat shock protein 90 \[hsp-90\], calreticulin, etc.). secondary objectives: i. to assess adverse event rates in participants receiving the high-dose radiation and sipuleucel-t therapy. ii. to assess prostate-specific antigen (psa) changes. iii. to assess overall and cancer specific survival. outline: patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-t dose. after completion of study treatment, patients are followed up at 3 and 6 months and then annually thereafter.

Eligibility criteria:
inclusion criteria: * have minimally symptomatic metastatic castration recurrent prostate cancer with bone lesions; this patient population is defined as having failed hormone treatment and has insurance approval for provenge® therapy * patients that have been prescribed sipuleucel-t and have not started treatment * must be candidates for radiation treatment to bone lesions * patient or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure * have an eastern cooperative oncology group (ecog) performance status of =\< 2 exclusion criteria: * patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study * patients who have received prior radiation of osseous lesions * patients who have received any prior immunotherapy * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * unwilling or unable to follow protocol requirements * any condition which in the investigator's opinion deems the patient an unsuitable candidate
measuring satisfaction of treatment with rebif after initial treatment of multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: this is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm study to measure treatment satisfaction of relapsing remitting ms (rrms) participants on rebif after discontinuing initial first-line treatment.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 65 years of age (both inclusive), at the time of informed consent * participants diagnosed with rrms according to mcdonald criteria 2010 * participants have discontinued treatment with dimethyl fumarate (tecfidera), teriflunomide (aubagio), glatiramer acetate (copaxone®), intramuscular ifnβ-1a (avonex®), pegylated interferon (plegridy®), subcutaneous ifnβ-1b (betaferon®) or fingolimod (gilenya®) within 6 months prior to visit 1 * currently treated with rebif using rebismart 2.0, for a maximum of 6 months prior to visit 1 * participants have a score on the expanded disability status scale (edss) between 0 to 5.0 inclusive * participants willing and able to give informed consent. exclusion criteria: * participants have known planned surgical procedures at the time of the informed consent that will prevent adherence to treatment with rebif through rebismart 2.0 * participants diagnosed with primary progressive, secondary progressive, or progressive relapsing ms * pregnant or lactating, or planning to become pregnant subjects * in the opinion of the investigator has significant renal or hepatic impairment or other significant disease (e.g., cognitive or visual impairment) that would compromise adherence and completion of the study * reports any reason that he/she cannot complete the 1 year study * participants have a history of hypersensitivity to natural or recombinant interferon, or any other component of the formulation * participants who contraindicated for the treatment with subcutaneous ifnβ-1a therapy as per summary of product characteristics or currently approved specific country product information * participants have any other factor that in the opinion of the investigator would make the subject unsuitable for participation in this study * participants have significant psychiatric symptoms that, in the opinion of the investigator, would impact patient ability to comply with treatment recommendations.

Keywords: relapsing remitting multiple sclerosis rebif treatment satisfaction questionnaire for medication version ii multiple sclerosis international quality of life questionnaire
comparison of taping techniques in plantar fasciitis

Conditions: Plantar Fasciitis; Pain; Foot Diseases

Summary: the aim of this study is to investigate the effects of low-dye and kinesio taping on pain and function in individuals with plantar fasciitis.

subject: in this study, the effects of low-dye taping and kinesio taping (kt) on pain and function will be investigated in individuals with plantar fasciitis. there are studies on both low-dye banding and kt in the literature and they are popular applications recently. however, to the best of our knowledge, when we look at the turkish and english literature, no study has been found comparing these two therapeutic massages in terms of pain, functionality and performance. purpose: plantar fasciitis (pf) is a clinical picture characterized by degeneration of the plantar fascia resulting from repetitive microtrauma to the plantar fascia causing an inflammatory reaction. it is one of the most common causes of heel pain in adults. the plantar fascia has a fundamental role in the biomechanics of the foot, supporting the medial longitudinal arch (mla), distributing forces and stresses of the foot during gait or other loading conditions. disorders in the musculoskeletal and somatosensory system in patients with plantar fasciitis may cause pain and decrease in functional capacity. therefore, its purpose is; this study was planned to show the effectiveness of taping methods applied in addition to eswt in individuals presenting with heel pain. thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with plantar fasciitis by a physician * age between 18 and 30 years * agree to participate in the study exclusion criteria: * not having surgery * disagree to participate in the study * infection * pregnancy * tumor
quantra qstat sample type comparison

Conditions: Coagulation Defect; Bleeding

Summary: this is a single center prospective observational study to compare qstat parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing liver transplantation.

in this single center prospective observational study, 25 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 75 matched samples for analysis on the quantra system with the qstat cartridge.

Eligibility criteria:
inclusion criteria: * subject is \>=18 years * subject is scheduled for liver transplant surgery * subject or subject's legally authorized representative (lar) is willing to provide informed consent exclusion criteria: * subject is younger than 18 years of age * subject is pregnant * subject is incarcerated at the time of the study * subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks * subject, or subject's lar, is unable or unwilling to provide informed consent

Keywords: quantra liver transplantation coagulation
efficacy study of intra-articular hyaluronic acid in the knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (sinovial®) in the symptomatic treatment of knee oa in comparison to synvisc®.


Eligibility criteria:
inclusion criteria: * age between 40 and 80 years * primary knee oa of the medial or lateral femoro-tibial compartment * symptoms for at least 3 months * diagnosis according to acr criteria * kellgren \& lawrence radiological grade 2-3 * patients who failed to respond sufficiently (not responders) to analgesics and/or nsaids taken regularly or responders intolerant to the regular use of analgesics and/or nsaids. * mean womac pain subscore at the target knee \>= 40 mm and \< 80 mm on a vas at baseline after wash-out from analgesics/nsaids· if bilateral knee oa: definition of the most symptomatic joint at screening based on patient's evaluation and investigator's clinical judgment and mean womac pain subscore at baseline in the contra-lateral knee \< 30 mm * written informed consent * subject able to understand, co-operative and reliable exclusion criteria: * bmi \>= 32 kg/m2 * secondary (post-traumatic) knee oa * predominantly patello-femoral pain/syndrome * no remaining joint space width * symptomatic hip oa or other interfering health condition * severe varus/valgus deformity (\>15°) * history/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations. * concomitant rheumatic disease * significant injury to the target knee in the last 6 months * previous joint replacement/arthroplasty (target knee) * arthroscopy/osteotomy/surgery in the past 1 year (target knee) * any surgery scheduled in the next 6 months * venous or lymphatic stasis in the relevant limb * skin infection/disease/trauma at the injection site * systemic or i.a. (target knee) corticosteroids in the past 3 months * i.a. corticosteroids (non-target joint) in the past 4 weeks * viscosupplementation (target knee) in the past year * recently started (in the last 3 months) physical therapy (target knee) * recently (in the last 3 months) started therapy or change in dosage of sysadoas * ongoing anticoagulant therapy * chronic or recurrent use of nsaids/analgesics/narcotics because of diseases different from oa of the target knee * history of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins * participation in a clinical study in the last 3 months * pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception * patients unable to stay in the study for 6 months, non-cooperating, not able to understand
study of immune responses after vaccination against seasonal influenza virus and against influenza h1n1-v pandemic virus in a medical staff.

Conditions: Influenza A Virus, H1N1 Subtype

Summary: this project may help to answer several fundamental questions related to public health regarding vaccination against influenza viruses and regarding the influenza a(h1n1)v pandemy: what is the immunologic efficacy in terms of antibodies response of the vaccination against the seasonal (2009-2010) influenza virus and against the a(h1n1)v virus in the clinical staff? moreover, it may help to answer questions related to the use of a vaccine against influenza virus variants emerging in the french population: 1. before the vaccination: * what is the status of the residual anti-h1n1 seasonal viruses immunity and of the anti-a(h1n1)v immunity in the population stratified by age and taking into account the multiplicity of the prior seasonal vaccinations? * what is the level of the cellular and humoral cross-reactivity between the different h1n1 strains? 2. after the vaccination: * what is the intensity of the anti-vaccine immune response as a function of the age of the population ad of the prior seasonal vaccinations? * what is the level of the cellular and humoral cross-reactivity after vaccination as a function of the age of the population and of the multiplicity of the prior seasonal vaccinations?


Eligibility criteria:
inclusion criteria: * healthy volunteers * age superior or equal to 20 years * women with childbearing potential using contraception exclusion criteria: * documented immune depression * current immunosuppressive therapy * pregnancy (documented by a positive pregnancy test) * breast feeding women * documented allergy or hypersensitivity to vaccines * documented acute or chronic inflammatory disease * concomitant participation to another clinical trial
phase i study mr-guided sbrt to pca

Conditions: Low or Intermediate Risk Prostate Cancer

Summary: 1) investigate the feasibility, tolerance, and safety of dose escalation via mr-guided stereotactic body radiation therapy and simultaneous integrated boost to the dominant intraprostatic lesions (dils), 2) to assess the feasibility of dil visualization based on multi-parametric mri (mpmri), and 3) to characterize longitudinal changes in imaging characteristics and identify urinary biomarkers for treatment response prediction


Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma. * patients with low or favorable intermediate risk prostate cancer and patients with unfavorable intermediate risk prostate cancer who decline androgen deprivation therapy * pretreatment evaluations must be completed as specified in section 4.0 * patients must sign a study-specific informed consent form prior to study participation. * no contraindication to mri. for example, patients with metal fragments or implanted devices such as pacemakers and aneurysm clips may not be eligible for the study * at least one intraprostatic lesion can be identified on the mpmr images. * patients agree to have hydrogel placed. exclusion criteria: * patients who have a contraindication to contrast-enhanced mri are not eligible. patients with an implanted device such as a pacemaker or metal fragments are not eligible.

Keywords: prostate cancer, mri, intraprostatic lesions
enhancing function using the rf microstimulator gait system following stroke 2008

Conditions: Stroke

Summary: the purpose of the study is to investigate new technology for recovery of ankle walking function after stroke.

background and purpose: conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. functional neuromuscular stimulation (fns) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. the purpose of the proposed work is to test the radio frequency-controlled (rf) microstimulator (rfm) gait system regarding system performance and subject response to treatment. methods: this is a feasibility study in which up to four subjects will receive the (rfm) gait system. up to ten rfms will be placed for a given subject. an rfm ankle muscle system will be used to train ankle gait components. a separate rfm system will be used to train knee gait components. subjects will be treated for 6 months, four sessions/wk. primary outcome measures for the rfm gait system will be: kinematic swing phase gait components and walking endurance. secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. the results of the rfm ankle system have the potential to provide a new technology for ankle muscle gait components.

Eligibility criteria:
inclusion criteria: * sufficient endurance to participate in rehabilitation sessions. * medically stable * age \>21 years. * inability to perform normal ankle coordinated gait components. * participants should be able to walk and keep balance without physical assistance from another person exclusion criteria: * acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy. * lower motor neuron damage or radiculopathy * allergy or contraindication to anesthesia, versed, (or comparable substitute. * active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device. * pregnancy

Keywords: functional electrical stimulation