Kornimate/medical-research-clean huggingface dataset:
calcific tendonitis treatment: barbotage vs. barbotage with cortisone injection

Conditions: Calcific Tendinitis

Summary: the purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.

calcific tendonitis is a condition caused by calcium deposits building up in a person's muscles or tendons. if calcium builds up in an area, a person may feel pain and discomfort there. the purpose of this study is to determine the efficacy of barbotage therapy (injecting and washing the shoulder joint with saline) by comparing the amount of pain, shoulder function, and x-rays in patients with calcific tendonitis that receive the standard of care, barbotage with cortisone injection, against barbotage with saline injection. receiving barbotage without cortisone is therefore considered experimental.

Eligibility criteria:
inclusion criteria: * must be at least 18 years of age and younger than 90 years of age * diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies * failed 1st line therapy (physical therapy and cortisone injection) * intention to receive barbotage with cortisone as standard of care * 3 or more months of shoulder pain * finding of one or more calcifications ≥5 mm in size on either sonogram or radiograph, located on the supraspinatus tendon * positive hawkin's test or neer's sign for impingement exclusion criteria: * legally incompetent or mentally impaired (e.g. minors, alzheimer's subjects, dementia, etc.) * osteoarthritis of the glenohumeral joint of the affected shoulder * previous surgery or barbotage to the affected shoulder * history of prior allergic/hypersensitivity reactions related to the study medication * shoulder instability, glenohumeral arthritis, ac pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy * sub-acromial injection with a corticosteroid or treatment by eswt during the last 3 months before inclusion * younger than 18 years of age or older than 90 * any patient considered a vulnerable subject
study to assess the short- and long-term efficacy of certolizumab pegol plus methotrexate compared to adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis (ra) inadequately responding to methotrexate

Conditions: Rheumatoid Arthritis

Summary: this study is conducted to evaluate the short (12 weeks) and long term (104 weeks) efficacy of certolizumab pegol compared with adalimumab both in combination with methotrexate (mtx) in the treatment of moderate to severe rheumatoid arthritis (ra) that is not responding adequately to mtx.


Eligibility criteria:
inclusion criteria: * subject must have a diagnosis of rheumatoid arthritis (ra) at screening, as defined by the 2010 european league against rheumatism (eular)/american college of rheumatology (acr) classification criteria (aletaha d et al, 2010) * subject must have a positive rheumatoid factor (rf) and/or a positive anti-cyclic citrullinated peptide antibody (anti-ccp) as determined by the central laboratory at screening * subject must have moderate to severe ra disease at screening and baseline defined as: 1. screening (all criteria required) * ≥ 4 swollen joints (of 28 prespecified joints) * disease activity score \[erythrocyte sedimentation rate\] (das28\[esr\]) \> 3.2 * c-reactive protein (crp) concentration ≥ 10 mg/l (or 1.0 mg/dl) or erythrocyte sedimentation rate (esr) (westergren) ≥ 28 mm/hr 2. baseline (both criteria required) * ≥ 4 swollen joints (of 28 prespecified joints) * disease activity score \[erythrocyte sedimentation rate\] (das28\[esr\]) \> 3.2 * subject must have inadequately responded previously to methotrexate (mtx) * subject is using mtx 15 to 25 mg/week orally or subcutaneously at screening and has used the same mtx regimen for a minimum of 28 days prior to baseline exclusion criteria: * subject has previously received any biological disease modifying antirheumatic drug (dmard) or has received treatment with cyclophosphamide, chlorambucil, janus kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase * diagnosis of any other inflammatory arthritis * infected with tuberculosis (tb) or high risk of acquiring tb infection * subjects with concurrent acute or chronic viral hepatitis b or c infection * subjects with a history of chronic or recurrent infections or subjects at high risk of infection * use of prohibited medications like nonbiological dmards (excluding mtx), biological dmards excluding study medications, experimental therapy, ia hyaluronic acid

Keywords: certolizumab pegol cimzia adalimumab humira rheumatoid arthritis
transcutaneous electrical acupoint stimulation on postoperative dizziness in hemifacial spasm patients

Conditions: Transcutaneous Electrical Acupoint Stimulation; Hemifacial Spasm; Dizziness

Summary: to observe the prevention and treatment effect of transcutaneous electrical acupoint stimulation (teas) on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and its possible mechanisms.

hemifacial spasm (hfs) is mainly caused by vascular compression on the roots of the vii cranial nerves from the brain stem. microvascular decompression (mvd) is the exact surgical method for the treatment of hfs, but the incidence of dizziness and postoperative nausea and vomiting (ponv) after mvd is extremely high. despite the use of dual antiemetic therapy during the operation, the incidence of ponv within 24 hours after mvd is still as high as 66.7%. medication alone has limited effects on dizziness and ponv treatment after mvd. meta-analysis shows that transcutaneous electrical acupoint stimulation (teas) is associated with the reduction of post-emetic remedies and the incidence of dizziness after general anesthesia, and it can be integrated into the multi-modal therapy of ponv. therefore, the purpose of our study is to observe the prevention and treatment effect of teas on postoperative dizziness in patients with hemifacial spasm undergoing microvascular decompression surgery, and explore its possible mechanisms.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status: i-iii * body mass index (bmi): 18-30 * diagnosed of hemifacial spasm * undergoing microvascular decompression surgery exclusion criteria: * pregnant or lactating women * poorly controlled hypertension or poorly controlled diabetes, severe cardiovascular and cerebrovascular diseases and mental illness * cardiac pacemakers * scars on bilateral neiguan acupoints or on the mastoid area * upper limb nerve injury * raynaud's syndrome * motion sickness or ponv history * eye diseases (glaucoma, cataracts, eye trauma, etc.) or previous eye surgery * participate in other clinical trials
stopping maintenance therapy in people with multiple myeloma in mrd-negative remission

Conditions: Plasma Cell Myeloma

Summary: this study will test whether stopping maintenance therapy in people with multiple myeloma in mrd-negative remission has the same effect on disease control as continuing this therapy. the study will look at whether people currently on maintenance therapy can safely stop this treatment and continue with active surveillance instead while keeping their mrd-negative remission status for at least 1 year.


Eligibility criteria:
inclusion criteria: * patients with plasma cell myeloma treated with any number of prior lines of therapy, who at the time of study enrollment have had sustained mrd-negativity at a given timepoint and a subsequent time point with an interval of 3 or more years while on continuous maintenance therapy. mrd-negativity is defined per the international myeloma working group consensus panel. * mrd positivity will be defined by detection of 1 or more neoplastic plasma cells in 10\^5 nucleated cells by flow cytometry as per imwg criteria (i.e., sensitivity of 10-5) * age \>/= 18 years with ecog performance status \</= 2 * patients must be able to understand and be willing to sign a voluntary informed consent form and agree to compliance with the protocol schedule; with the knowledge that they may withdraw consent at any time without impact on future medical care exclusion criteria: * patients found to be mrd-positive at time of screening * patients with plasma cell leukemia or other disorder of plasma cell neoplasm * patient who are receiving other therapy with the intent of treating myeloma with the exception of bisphosphonates * patients being treated for another, potentially life-limiting malignancy with 3-year lead-in to study enrollment, with the exception of non-melanoma skin cancer or in situ malignancy or malignancies that have received definitive curative therapy * prior organ transplant or condition requiring immunosuppressive therapy * prior allogeneic hematopoietic cell transplant * patients with any other ongoing, concomitant, comorbid illness including but not limited to uncontrolled diabetes, nyha class iii or iv heart failure, uncontrolled coronary artery disease/arrhythmia, psychiatric or social disorder that would compromise compliance with the study schema

Keywords: plasma cell myeloma mrd-negative mrd-negative remission memorial sloan kettering cancer center 19-422
relaxation treatment for anxiety in adults aged 60 or older

Conditions: Anxiety Disorders

Summary: the pi developed a self-directed program to treat late-life anxiety called breathing, relaxation, and education for anxiety treatment in the home environment (breathe). this program consists of weekly video lessons that participants watch on digital video disc (dvd) along with weekly telephone check-ins. in breathe participants will learn two behavioral interventions: diaphragmatic breathing and progressive muscle relaxation (pmr). the purpose of the study is to examine whether the self-directed breathe program is superior to a wait list control in reducing anxiety in older adults with anxiety disorders. for those assigned to wait list control, they will be offered opportunity to participate in breathe treatment after 8 weeks of wait list.


Eligibility criteria:
inclusion criteria: * participants have a diagnosis of an anxiety disorder, specifically, generalized anxiety disorder, panic disorder, agoraphobia, social anxiety disorder or anxiety disorder unspecified/other specified). * participants speak english. exclusion criteria: * diagnosis of dementia * probable presence of significant cognitive impairment according to a brief cognitive screen * serious mental illness (schizophrenia, psychosis, bipolar disorder)
the effectiveness and cost-effectiveness of doin (conduction exercise) for chronic neck pain

Conditions: Chronic Neck Pain

Summary: a multi-center randomized controlled trial assessing the comparative effectiveness and cost-effectiveness of doin (conduction exercise) with acupuncture for chronic neck pain

a multi-center randomized controlled, parallel, assessor-blinded full-scale trial will be conducted based on the results of the pilot study to evaluate the comparative clinical effectiveness and cost-effectiveness of doin (conduction exercise) with acupuncture for chronic neck pain patients compared to acupuncture alone as assessed using pain, functional disability, health-related quality of life, economic evaluation, and safety measures.

Eligibility criteria:
inclusion criteria: * neck area pain duration of 6 months or longer * current numeric rating scale (nrs) for neck area pain of 5 or higher * patients who have agreed to voluntarily participate in the clinical trial and given written informed consent exclusion criteria: * patients diagnosed with serious pathology(s) which may cause neck pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis) * progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness) * pathologies of non-spinal or soft tissue origin or high severity which may cause neck or radiating arm pain (e.g. malignant tumor, spinal infection, inflammatory spondylitis, fibromyalgia, rheumatic arthritis, gout) * other chronic diseases which may interfere with treatment effect or interpretation of results (e.g. cardiovascular disorder, renal disease, diabetic neuropathy, dementia, epilepsy) * current intake of steroids, immunosuppressant medicine, psychiatric medicine or other medication which may interfere with treatment results * patients considered unsuitable or unsafe to receive acupuncture (e.g. patients with hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, severe diabetes with high risk of infection, severe cardiovascular diseases) * patients who were treated with invasive interventions such as acupuncture or injections, or with medicine that may potentially influence pain such as nsaids (nonsteroidal antiinflammatory drugs) within the past week * history of cervical surgery within the past 3 months * pregnancy or plans of pregnancy * severe psychopathy * participation in other clinical studies * inability to give written informed consent * other reasons rendering trial participation inappropriate as judged by the researchers
interest of auriculotherapy in the treatment of xerostomia

Conditions: Xerostomia

Summary: the aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia


Eligibility criteria:
inclusion criteria: * patients over 18 years old; * complain about xerostomia after cervical irradiation in the context of ent cancer; * end of radiotherapy\> 3 months * covered by a national healthcare insurance * consent form signed. non inclusion criteria: * pregnant or breastfeeding women; * local counterindication to auriculotherapy; * with anticoagulant treatment; * history or existing of hemophilia; * valvular prosthesis; * ear's pavilion infection; * treatment by auriculotherapy or acupuncture in this indication in the previous 12 months; * having started in the 48 hours preceding the first auriculotherapy session, any new management of xerostomia and likely to interfere with the study (specific medication and/or complementary therapeutic management); * difficulty to comply with the treatment, questionnaires or study protocol; * being deprived of liberty or under guardianship.

Keywords: auriculotherapy xerostomia ent cancer
ischaemia-réperfusion during the coronary surgery with beating heart

Conditions: Ischaemia-reperfusion Injury

Summary: less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (cabg) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. the aim of this study was to compare the preventive effects of diltiazem and n-acetylcysteine (nac), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump cabg surgery.


Eligibility criteria:
inclusion criteria: * age included between 60 and 80 years exclusion criteria: * age \ 80 years * pregnancy * the allergy in used medicines (n-acétylcystéine, diltiazem) * presence of a pathology valvulaire associated * urgency * unstable angor * bypass as a matter of urgency * recours peropératoire to a cec * fe \< 0,40 * bav of the 2nd and 3rd not sailed degree * fibrillation or flutter little finger.

Keywords: ischaemia-reperfusion injury cardiac surgery oxidative stress markers troponin diltiazem acetylcystein
comparison of the performance and safety of t2769 versus vismed® multi in the treatment of moderate to severe dry eye syndrome

Conditions: Dry Eye

Summary: to demonstrate the non-inferiority of t2769 compared to vismed® multi in terms of total ocular surface staining (oxford score) after 35 days of treatment. to evaluate the performance and safety of t2769 versus vismed® multi.


Eligibility criteria:
inclusion criteria: * informed consent signed and dated (obtained prior to initiating any procedures). * patient aged ≥18 years old. * known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit. * surface disease index (osdi) score ≥ 23. * ocular discomfort evaluated by vas ≥ 40 mm. exclusion criteria: * far best-corrected visual acuity (bcva) ≥+0.7 logmar (e.g., ≤0.2 in decimal value or ≤20/100 snellen equivalent or ≤50 (etdrs) letters early treatment diabetic retinopathy study). * severe blepharitis according to the judgment of the investigator * dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, pterygium, eyelid malposition, corneal dystrophy, ocular neoplasia, filamentous keratitis, corneal neovascularisation, orbital radiotherapy, cataract, retinal disease.
post-operative analgesic effect of oral nefopam

Conditions: Postoperative Pain After a Total Knee Arthroplasty

Summary: primary knee arthroplasty by total prosthesis is a painful surgery, performed on patients with advanced gonarthrosis (stage iii), thus already presenting hyperalgesia and hyperalgesia and allodynia. this terrain makes the risk of postoperative hyperalgesia but also of persistent postoperative risk of persistent post-surgical pain. nefopam is a non-opioid centrally acting analgesic drug used as a part of multimodal analgesia. the opioid-sparing effect of nefopam is still controversial across various surgical procedures. in france nefopam is only available as a parenteral formulation; however it is often administered orally. there is currently no study addressing the efficacy of oral nefopam for the postoperative pain management including pain prevention. the investigators conduct a prospective, double-blinded randomized controlled study with the main objective to examine the effect of perioperative orally administered nefopam on postoperative pain after a total knee arthroplasty. secondary objectives include the quantification of wound allodynia, analysis of adverse events, clinical outcomes, and a pharmacokinetic study of orally given nefopam (plasma and cerebrospinal fluid dosage).


Eligibility criteria:
inclusion criteria: * adult patients scheduled for a total knee arthroplasty under spinal anesthesia at the hopital de la croix rousse, hospice civils de lyon, france. * asa (american society of anesthesiology) class between 1 et 3. * written informed consent exclusion criteria: * any contraindication for nefopam (known hypersensitivity, past medical history of seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic cardiomyopathy waiting for revascularization, atrial fibrillation) * medical conditions known to influence the pharmacokinetics of nefopam (chronic kidney failure with glomerular filtration rate (gfr) \<30ml/min/1,73m2, liver failure, current treatment with rifampicin, carbamazepine, azoles fungicides, macrolides) * current treatment with benzodiazepines, anxiolytics, antidepressants, histamine h1 antagonists, neuroleptics, baclofen, thalidomide, barbiturates * medical history of gastric or esophageal surgery. * phenylketonuria * pregnancy or breastfeeding * past use of oral nefopam

Keywords: nefopam oral postoperative pain hyperalgesia cerebrospinal fluid and plasma concentration total knee arthroplasty
an advance care planning programme for persons with early stage dementia in the community

Conditions: Dementia Mild; Mild Cognitive Impairment

Summary: advance care planning (acp) has been widely advocated for persons with early stage dementia (pweds) and persons with mild cognitive impairment (mci). this proposed study attempts to promote the uptake of acp for this population and their family caregivers in the community and to examine the effects of an acp programme "have a say" for this population. it is hypothesized that participants received the intervention will be more engaged in acp and their dyadic concordance on end-of-life care preference with their family caregivers will be higher after the intervention.

this study aims to evaluate the impacts of an advance care planning (acp) programme "have a say" for persons with early stage dementia (pweds) or mci and their family caregivers in the community. a quasi-experimental study with repeated blinded outcome assessment will be conducted to assess the effects of an acp programme on dyads of pweds or persons with mci and their family caregivers recruited from elderly community centres. individuals who have a clinical diagnosis of any form of dementia at the early stage or mci or have a global deterioration score (gds) 3 or 4 will be eligible to this study. participants will receive a 4-session acp programme. it includes an educational component, guided reflection and acp discussion through a series of group-based activity and dyadic discussion delivered by trained acp facilitator and guided by an acp booklet. dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. their values and care preferences on future care will be elicited in a consistent manner. they will be supported to have an individualized acp discussion. the primary study outcome is the acp engagement level of pweds. secondary outcome is the dyadic concordance on end-of-life care preference. adverse outcomes such as depression and caregivers' burden will also be evaluated. data collection will be conducted at baseline, immediately after, and one-month after the intervention.

Eligibility criteria:
inclusion criteria: * aged 55 years or over; * being chinese, * being a cantonese speaker, * having a global deterioration scale score 3 or 4, * having a designated family caregiver willing to participate in this study exclusion criteria: * non-communicable, * mentally incompetent, * received an acp intervention, * have previously signed an advance directive, * have other life-limiting chronic illnesses with a life expectancy of less than 6 months.

Keywords: advance care planning