Kornimate/medical-research-clean huggingface dataset:
effectiveness and safety of yisaipu combined with tripterygium wilfordii for active ra

Conditions: Arthritis, Rheumatoid

Summary: in this 24-week, multi-center, randomized, double-blind study, the investigators will evaluate the efficacy and safety profile of subcutaneously injected yisaipu, a tumor necrosis factor receptor fusion protein, combined with oral tripterygium wilfordii for patients with active rheumatoid arthritis.

this study evaluates the efficacy and safety of yisaipu plus tripterygium wilfordii (t2w) for the treatment of ra patients. yisaipu is a recombinant human tumor necrosis factor receptor fusion protein, and tripterygium wilfordii is a chloroform/methanol extract of tripterygium wilfordii hook f. objectives: 1. to compare the efficacy of yisaipu plus t2w versus mtx monotherapy for the treatment of signs and symptoms of ra. 2. to evaluate the safety of yisaipu plus t2w in patients with ra for 24 weeks. design: this is a randomized, 24-week, double-blind, parallel group study, and 506 patients with active ra will be randomized in a 1:1:1:1 ratio to one of the following four parallel treatment arms: 1. methotrexate monotherapy 2. t2w monotherapy 3. yisaipu plus methotrexate 4. yisaipu plus t2w escape: on week 13, all participants with inadequate response, defined as a \<30% improvement of swollen and tender joint counts from baseline, will switch to yisaipu plus t2w treatment throughout the study. endpoints : 1. acr20, acr50 and acr70 response rates at 12 and 24 weeks. 2. das 28 (crp) and das 28 (esr) at 12 and 24 weeks. 3. eular response rates at 12 and 24 weeks. 4. health assessment questionnaire (haq) at 12 and 24 weeks. 5. patient assessment of arthritis pain at 12 and 24 weeks. 6. patient and physician global assessment of arthritis at 12 and 24 weeks.

Eligibility criteria:
inclusion criteria: * age 18-65 years with informed consent * diagnosis of rheumatoid arthritis (according to 2010 acr/eular classification criteria) * disease duration \> 6 weeks * swollen joint (sjc)≥4 and tender joint count(tjc)≥4 * esr \>28 mm/hr or c-reactive protein \> 1.5 uln * positive rf or anti-ccp antibody on screening * class i, ii or iii of the acr 1991 revised criteria for global functional status in ra * no evidence of active or latent or inadequately treated mycobacterium tuberculosis infection exclusion criteria: * pregnant, lactating or further fertility requirements * previously received any biologic agents. * recently (\<12 weeks) received methotrexate, leflunomide, salazosulfapyridine, azathioprine, cyclosporine, mycophenolate mofetil or tripterygium wilfordii. * active or chronic infection, including hiv, hcv, hbv, tuberculosis. * history of any other rheumatic autoimmune disease * history of any lymphoproliferative disorder * malignancy or history of malignancy. * abnormal laboratory tests, including: hemoglobin \ 1.5 uln, and serum creatine \> 1.5 mg/dl. * severe, progressive, or uncontrolled cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease

Keywords: rheumatoid arthritis methotrexate tripterygium tnf inhibitor
the nanowear wearable system simplesense validation trial for cardiac output

Conditions: Right Heart Catheterization

Summary: the nanowear simplesense study is a single center, prospective, non-randomized, feasibility, non- significant risk study the study will be done in 2 phases. phase 1 will use simplesense data collected from the first set of subjects and associate the data from simplesense to the right heart catheterization values.' phase 2 will evaluate the algorithms developed to estimate cardiac output from simplesense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from simplesense to the data from the right heart catheterization.

patients undergoing right heart catheterization for a clinical indication including but not limited to prognosis for advanced heart failure, during endomyocardial biopsy, candidacy for heart transplant or management of cardiogenic shock. study design: the nanowear simplesense study is a single center, prospective, non-randomized, feasibility, non- significant risk study the study will be done in 2 phases. phase 1 will use simplesense data collected from the first set of subjects and associate the data from simplesense to the right heart catheterization values.' phase 2 will evaluate the algorithms developed to estimate cardiac output from simplesense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from simplesense to the data from the right heart catheterization. number of subjects and sites: the nanowear simplesense study will enroll up to 100 subjects to collect data at westchester medical center. the testing will include a simplesense device recording and simultaneous measurement of cardiac output, and pulmonary artery pressure by right heart catheterization. duration of study: the duration of the nanowear simplesense study is expected to be 1 year. study population: subjects of legal age to give informed consent who are undergoing right heart catheterization for a clinical indication including but not limited to : * prognosis of advanced heart failure * during endomyocardial biopsy * candidacy for heart transplant * management of cardiogenic shock

Eligibility criteria:
inclusion criteria: 1. subject has provided informed consent 2. male or female over the age of 18 years 3. the patient is undergoing right heart catheterization exclusion criteria: 1. subject unwilling or unable to comply with wearing the nanowear simplesense system. 2. subjects who are pregnant 3. severe aortic stenosis.

Keywords: cardiac output right heart catheterization simplesense algorithm pulmonary artery pressure heart failure endomyocardial biopsy cardiogenic shock
what is the perceived role of risk in doc healthcare.

Conditions: Disorders of Consciousness

Summary: critical ethnography exploring how decisions are made on behalf of people in disorder of consciousness (doc). prospective longitudinal case study design including observation, field interview and video reflexive ethnography.


Eligibility criteria:
inclusion criteria: * people in a doc: * working diagnosis of being in a doc. * have an appropriate family member able to act as a consultee. * over 18 years of age. family members and healthcare workers: * conversational english. * able to give consent. * over 18 years of age. * involved in decision making on behalf of a person in a doc exclusion criteria: person in a disorder of consciousness * not in a doc, diagnosis uncertain, or appears to be emerging. * clinically unstable or approaching the end of their life.

Keywords: disorders of consciousness decision making
comparison of spencer's muscle energy technique and post-facilitation stretch in patients with adhesive capsulitis

Conditions: Frozen Shoulder

Summary: adhesive capsulitis is one of the most common problems of the upper limb. adhesive capsulitis (ac) and frozen shoulder syndrome (fss) are two terms that have been used to describe a painful and stiff shoulder. conservative treatment includes transcutaneous electrical nerve stimulation (tens), ultrasound, laser, range of motion, stretching and strengthening exercises, patient education, and home exercises. manual therapy includes mobilization, spencer's muscle energy technique and mobilization with movement.

the american academy of orthopedic surgeons defines this condition as: "a condition of varying severity characterized by the gradual development of global limitation of active and passive shoulder motion where radiographic findings other than osteopenia are absent." patients with frozen shoulder typically experience insidious shoulder stiffness, severe pain that usually worsens at night, and near-complete loss of passive and active external rotation of the shoulder. although spencer's muscle energy technique is a very effective technique, still it was rarely used. it is a standardized series of steps of shoulder treatments with broad application in diagnosis, treatment, and prognosis developed by spencer in 1961 and is a well-known osteopathic manipulative technique that focuses on mobilization of the glenohumeral and scapulothoracic joints. it is an articulatory technique in which passive, smooth, rhythmic motion of the shoulder joint is done by the therapist to stretch contracted muscles, ligaments, and capsule. most of the force is applied at the end range of motion. this technique increases pain-free range of motion by stretching the tissues, enhancing lymphatic flow, and stimulating increased joint circulation. on the other hand, "post-facilitation stretch (pfs)" is a muscle energy technique developed by dr.vladimir janda to lengthen chronically shortened muscles that involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a 20-second static stretch. this technique is more aggressive than post isometric relaxation and based on the concept of autogenic inhibition

Eligibility criteria:
inclusion criteria: * patients with primary unilateral adhesive capsulitis * stage ii and iii adhesive capsulitis * patients with limited active and passive range of motion of the affected shoulder (globally loss of at least 50% compared to non-involved shoulder in one or more directions) * patients with controlled diabetes exclusion criteria: * patients with a positive history of trauma, fracture, or surgery of the cervical spine * corticosteroid injection in the affected shoulder in the preceding 4 weeks. * malignancy/avascular necrosis of shoulder * post-traumatic shoulder stiffness * thoracic outlet syndrome/neurological disorder * patients with cervical radiculopathy

Keywords: spencer muscle energy technique post facilitation pain range of motion
zemaira in subjects with emphysema due to alpha1-proteinase inhibitor deficiency

Conditions: Alpha1-proteinase Inhibitor Deficiency; Emphysema

Summary: this is a randomized, placebo-controlled, double-blind, multicenter phase iii/iv study to compare the efficacy and safety of zemaira® with placebo in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. the effect of zemaira® on the progression of emphysema will be assessed by the decline of lung density, measured by computed tomography (ct).


Eligibility criteria:
inclusion criteria: * 18 to 65 years of age and willing to sign informed consent. * males and non-pregnant, non-lactating females whose screening pregnancy test is negative and who are using contraceptives methods deemed reliable by the investigator. * diagnosis of alpha1-proteinase inhibitor (a1-pi) deficiency (serum a1-pi levels \< 11 μm or \< 80 mg/dl). this includes newly diagnosed subjects, previously untreated subjects, currently treated subjects, and subjects currently not on treatment therapy but on treatment in the past. * subjects with emphysema and forced expiratory volume in 1 second (fev1) ≥ 35% and ≤ 70% (predicted). * no signs of chronic or acute hepatitis a, hepatitis b, hepatitis c or hiv infection (negative serologies for hiv and viral hepatitis). in case of positive serologies for viral hepatitis, vaccination status or negative igm should be available. exclusion criteria: * any relevant chronic diseases or history of relevant diseases (e.g., severe renal insufficiency) except respiratory or liver disease secondary to alpha1-proteinase inhibitor deficiency. subjects with well-controlled, chronic diseases may be included after consultation with the treating physician and the sponsor. * current evidence of alcohol abuse or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids. * history of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol. * history of transfusion reactions. * selective iga deficiency. * acute illness within one week prior to the first administration of the investigational medicinal product (imp). start of treatment after recovery is possible. * current tobacco smoker (smoking has to be ceased at least 6 months prior study inclusion). subjects with a positive cotinine test due to nicotine replacement therapy (e.g. patches, chewing gum) or snuff are eligible. * conditions or behaviors that interfere with attending scheduled study visits in the opinion of the investigator. * history of non-compliance. * administration of any other experimental new drug or participation in an investigation of a marketed product within one month prior to the screening visit date. * inability to perform necessary study procedures. * lung transplantation, lung volume reduction surgery or lobectomy or being on a waiting list for any such surgeries.

Keywords: alpha1-proteinase inhibitor deficiency emphysema chronic augmentation and maintenance therapy
physiotherapy investigation in patient with temporomandibular joint dysfunction

Conditions: Temporomandibular Disorders (TMD)

Summary: knowing the associated factors for people suffering from tmd may help to develop preventive, therapeutic and health strategies. the aim of this study was to present the assessments of audiovestibular symptoms in people with tmd. the main question it aims to answer is the questions are as follows: 1. is there a relationship between tmj symptoms and audiovestibular assessment in people with tmd? participants will: participants diagnosed with tmd will be informed about the study and informed consent will be obtained. data obtained after the tmj and vestibular system evaluation of the participants will be analyzed.

temporomandibular dysfunction (tmd) is a health condition affecting the temporomandibular joint (tmj) and related structures. the prevalence of tmd in adults affects a very large portion of the world's population. tmd is complex and multifactorial due to its etiology with neuromuscular, traumatic, degenerative and sociodemographic aspects. the aim of this study is to reveal audiovestibular assessments in individuals with tmd. after obtaining voluntary consent forms, participants are subjected to assessments. the "statistical package for social sciences (spss) statistics 23.0 (spss inc, chicago, usa) program will be used in the analysis of the study data. before starting the analysis of the data, the kolmogorv smirnov test will be used to check whether the data is suitable for normal distribution. data that are suitable for normal distribution will be analyzed with parametric tests, and those that are not suitable for normal distribution will be analyzed with non-parametric tests. descriptive statistics for quantitative variables will be shown as mean and standard deviation, and for qualitative variables determined by counting, descriptive statistics will be shown as numbers and percentages. t-test/chi square/mann whitney u will be used in two-group comparisons, and one-way variance analysis/kruskal wallis test will be used in three-group comparisons.

Eligibility criteria:
inclusion criteria: * volunteer to participate in the study between the ages of 18-35 * diagnosed with unilateral tmj disorder at least 1 month ago according to the - research diagnostic criteria of temporomandibular disorders (rdc/tmd) classification (dworkin et al., 1992) * having muscle tenderness and pain in the temporomandibular joint region exclusion criteria: * traumatic injuries in the same area other than tmd * ear diseases that cause hearing loss * dentofacial anomalies * receiving orthodontic treatment * neurological diseases, vestibular or visual problems

Keywords: temporomandibular dysfunction pain
national clinical-biological prospective cohort of incident cases of aggressive fibromatosis (altitudes)

Conditions: Aggressive Fibromatosis

Summary: the purpose of this study is to constitute the french largest aggressive fibromatosis cohort.

aggressive fibromatosis (af) is a rare non-metastasizing connective tissue tumor (\< 300 cases/year in france), associated with high risk of local relapse, functional impairment and pain. af can occur at any age, but most commonly between 25 and 40 with a significant female predominance. af is most frequently (about 85%) sporadic and then associated with a somatic mutation of the ctnnb1 gene. af is associated with heredity condition, as complication of familial adenomatous polyposis (with germinal mutation of adenomatous polyposis coli (apc) gene). most of af arises on lims or abdominal wall. nevertheless, some particular locations are life-threatening (mesenteric or cervical locations). the natural course of af is unpredictable. one third of tumors are spontaneously stable. one third of tumor spontaneously decreases. one third of tumor is progressive, with a non-linear tumor growth dynamic. as the consequence the decision making for starting curative intent treatment is difficult, since some treatment could be mutilating (large en bloc surgery) or associated with late and severe complications (radiotherapy) and since these treatments could fail to control this benign tumor. therapeutic options are: wait-and-see policy, surgery (sometimes mutilating), radiotherapy or systemic treatment (non-steroidal anti-inflammatory drugs, hormonotherapy, imatinib, chemotherapy). level of evidence associated these options is very low, based on retrospective studies and rare non-randomized phase ii clinical trials. regarding these uncertainties, physicians can hardly answer to patient questions. prospective data provided by a large multi-center cohort is needed. the objective of the present study is to create a large cohort of incident cases of af associated with tumor bank and collection of blood samples.

Eligibility criteria:
inclusion criteria: * incident case of aggressive fibromatosis in france, diagnosed after 01/01/2016 * confirmed diagnosis by the french anatomopathological diagnosis network (including search for mutation of the β-catenin gene, ctnnb1) * affiliation to the national health system * informed consent signed (both parents signature for non adult patients) exclusion criteria: * administrative or legal measure of liberty privation * patient not able to give consent or unwilling to provide consent

Keywords: desmoid tumour
effect of ankle-foot orthoses on balance confidence

Conditions: Peripheral Nerve Disease; Peripheral Nerve Injury Lower Limb; Poliomyelitis; Cerebral Palsy; Multiple Sclerosis

Summary: the patients at our prosthetics and orthotics outpatient clinic who have had an ankle-foot orthosis for at least one year will fill in the activities-specific balance confidence scale (abc scale) for wearing the orthosis and for not wearing the orthosis. they will also answer a mini survey about falls in order to determine whether they have fallen within the last 6 months.

the effect of the orthosis will be estimated as the difference between the two abc scale scores. the abc scale score and individual items will be compared between the fallers and the non-fallers.

Eligibility criteria:
inclusion criteria: * patients at our prosthetics and orthotics outpatient clinic having an ankle-foot orthosis for at least 1 year exclusion criteria: * insufficient cognitive ability to fill in the abc scale

Keywords: ankle-foot orthoses lower limbs rehabilitation outpatients balance confidence falls
influence of oxidative dysbalance on secondary osteoarthritis

Conditions: Osteoarthritis

Summary: the important role of mechanical joint stress for the insert and progress of osteoarthritis (oa) is supported by recent studies. the degeneration of joint cartilage is caused either by unphysiological load of a healthy joint or physiological load of a damaged joint. the exact mechanisms leading from increased weight bearing and overuse to cartilage degeneration are mostly unknown. the hypothesis of the study is that parameters of oxidative stress in the joint synovial space reflect damages possibly leading to oa. these parameters correlate with parameters of oxidative stress in the peripheral blood. aim of the study is the identification of such non- invasive obtainable biomarkers which represent the degenerative and regenerative changes in joint.

patients with clinically manifest oa typically consult the physician at time of irreversible cartilage destruction. this is due to the long time clinically silent progress of the disease. a biomarker screening profile for joint damage is a valuable tool for the detection of over use and joint damaging conditions especially in competitive sports. this would provide a method for oa risk assessment for the patient before clinical symptoms occur. for this the first step is the identification of biological substances reflecting pathologic changes in the joint. since preterm chondrocyte senescence, apoptosis and ageing related changes are key factors in oa pathophysiology and each of these factors is closely related to oxidative dysbalance the measurement of these factors and correlation with the amount of joint damage is promising.

Eligibility criteria:
inclusion criteria: * planned knee joint arthroscopy * no history of trauma exclusion criteria: * neoplasia * rheumatoid arthritis * intake of steroids, cytostatic drugs,immunosuppression * pregnancy or lactation * addiction * participation in other clinical trials

Keywords: oxidative dysbalance oxidative stress biomarker
68ga-p3 pet/ct imaging in malignancy

Conditions: Neoplasms

Summary: prostate-specific membrane antigen (psma) is a type ii transmembrane glycoprotein that consists of 750 amino acids. it is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making psma a highly specific and significant imaging target for malignancies. \[68ga\]p3, a novel molecular probe of pet imaging agent that targets psma, can be used in the diagnosis and research of a wide variety of psma high-expression malignanciesr.

prostate-specific membrane antigen (psma) is a type ii transmembrane glycoprotein that consists of 750 amino acids. it is highly expressed on most prostate cancer cells and neovascular endothelial cells of tumors, making psma a highly specific and significant imaging target for malignancies.\[68ga\]p3, a novel molecular probe of pet imaging agent that targets psma, can be used in the diagnosis and research of a wide variety of psma high-expression malignanciesr.

Eligibility criteria:
inclusion criteria: patients with confirmed or suspected cancer; 18f-fdg pet/ct within 1 week; signed written informed consent exclusion criteria: pregnant and lactating women; female patients plan to become pregnant within 6 months.

Keywords: [68ga]p3 psma pet/ct neoplasms