Kornimate/medical-research-clean huggingface dataset:
pilot study of tocilizumab monotherapy for active chronic periaortitis

Conditions: Chronic Periaortitis; Tocilizumab Monotherapy

Summary: this is a prospective study to investigate the treatment response of tocilizumab on patients with active chronic periaortitis (cp). methods: patients with a definite or possible diagnosis of cp at acute active stage were enrolled for this study and accepted tocilizumab monotherapy for 3 months. endpoints: the primary endpoint is to investigate the treatment response of tocilizumab; the secondary endpoints include the improvement of inflammatory markers, the frequency of adverse events.

patients enrolled received intravenous infusions of tcz (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months. demographic and clinical features, laboratory findings and imaging examinations were recorded at baseline and during 3-month follow-up. imaging improvement was converted into the ratio of perivascular soft tissues shrinkage by evaluating 2 dimensions of greatest change on computed tomography (ct) at baseline and after 3 months. partial remission was defined as obtaining alleviation of symptoms and normalization of inflammatory markers including erythrocyte sedimentation rate (esr) and high-sensitivity c-reactive protein (hscrp), with shrinkage of soft tissue mass in imaging \<70%. further, complete remission was defined as normalization of inflammatory markers accompanied by shrinkage of soft tissue mass ≥70%.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years of age at time of informed consent; 2. meet clinical diagnostic criteria including (1) imaging findings show perivascular soft tissue density mass surrounding thoracic aorta, abdominal aorta or iliac arteries; (2) histopathological findings show fibrous tissue with chronic inflammatory infiltrate comprised of lymphocytes, plasma cells and macrophages (neutrophils and granulomas are rare). patients who satisfied (1) but without histopathological examination were perceived as possible cp; 3. at active stage: clinical symptoms or organ involvement; a higher level of esr and crp than normal; exclusion criteria: 1. secondary forms of cp related to drugs, infections, malignancies, erdheim-chester disease or other autoimmune diseases were excluded. 2. combined with other autoimmune diseases. 3. known immunodeficiency disorder. 4. pregnancy, lactation, or planning to become pregnant within 6 months of the test. 5. positive test for, or prior treatment for, hepatitis b or hiv infection. a positive test for hepatitis b is detection of hepatitis b surface antigen (hbsag) or hbv-dna. 6. evidence of active tuberculosis (tb), including chest x-ray and ppd. 7. severe abnormal liver function or cardiac insufficiency. 8. any reason the investigator think that should not attend this trial.

Keywords: chronic periaortitis tocilizumab treatment response complete remission partial remission
this study will evaluate the efficacy and safety of lcz696 compared to enalapril on morbidity and mortality of patients with chronic heart failure

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the study will evaluate the efficacy and safety of lcz696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (nyha class ii - iv and ef =\< 35%).


Eligibility criteria:
inclusion criteria: * patients must give written informed consent before any assessment is performed. * outpatients ≥ 18 years of age, male or female. * patients with a diagnosis of chf nyha class ii-iv and reduced ejection fraction (ef =\< 35%) and elevated bnp. * patients must be on an acei or an arb at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks. * patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks. exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. * history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, aceis, arbs, or nep inhibitors as well as known or suspected contraindications to the study drugs. * previous history of intolerance to recommended target doses of aceis or arbs * known history of angioedema. * requirement of treatment with both aceis and arbs. * current acute decompensated hf (exacerbation of chronic hf manifested by signs and symptoms that may require intravenous therapy). * symptomatic hypotension and/or a sbp \< 100 mmhg. * estimated gfr \< 30 ml/min/1.73m2 as measured by the simplified mdrd formula * serum potassium \> 5.2 mmol/l. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic heart failure cardiovascular death hospitalization outcome study bnp kccq egfr
self-managed integrative yoga therapy for older adults living with chronic pain

Conditions: Chronic Pain

Summary: chronic pain self-management skills can help patients improve daily functioning and quality of life. the goal of this study is to evaluate chronic pain self-managed integrative yoga therapy intervention delivered in a sample of 25 older adults recruited from community site in leicester.


Eligibility criteria:
inclusion criteria: * willing to provide informed consent * age \>= 60 years * ambulatory * community-living * self-reported chronic musculoskeletal pain \> 3 months having pain made it difficult to do usual activities * ability to attend sessions one in a week for 6-weeks exclusion criteria: * serious illness or hospitalisation in last 3-month * planned surgery in next six months * significant cognitive impairment * other severe physical or psychiatric disorder
maintenance therapy post-hsct in high-risk aggressive lymphoma

Conditions: High-risk Aggressive Lymphoma After Auto-HSCT

Summary: relapse after autologous hematopoietic stem cell transplantation (asct) is still challenging for high-risk aggressive lymphoma. this study was to investigate the efficacy and safety of maintenance therapy post-asct.


Eligibility criteria:
inclusion criteria: * age 14-70 years * high-risk aggressive lymphoma underwent auto-hsct * presence of 2 or more signs of unfavorable prognosis (ipi 2-4) * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * adequate hematological function * offer informed consent exclusion criteria: * concomitant other cancer * congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction * renal insufficiency (serum creatinine greater than 0.2 mmol/l) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome) * liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis b or c with serum bilirubin greater than 1.5 standards, alanine aminotransferase (alt) and aspartate aminotransferase (ast) greater than 3 standards, prothrombin index less than 70% * severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea \> 30 in min., hypoxemia less than 70 mm hg, when it is impossible to compensate situation in 2-3 days) * severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system * pregnancy
adjuvant targeted-therapy for patients with resected high-risk egfr-mutant stage ib-iia non-small cell lung carcinoma

Conditions: NSCLC; EGF-R Positive Non-Small Cell Lung Cancer

Summary: this is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage ib-iia non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection. the primary endpoint: 2-year dfs rate; the second endpoint: dfs


Eligibility criteria:
inclusion criteria: 1. subjects aged ≥18 and ≤75 years old； 2. ecog performance status score 0-1； 3. stage ⅰb-ⅱa（according to the 8th edition of the ajcc staging system）； 4. complete surgical resection of the primary nsclc is mandatory； 5. histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces \[stas\], etc.); 6. the tumour harbours one of the most common egfr mutations (19del or l858r) ; 7. normal organ and bone marrow function measured before the study as defined below: 1) hemoglobin (hgb)≥90g/l 2) white blood cell count (wbc) is 4.0\~10×10\^9/l 3) absolute value of neutrophil (anc)≥1.5×10\^9/l 4) platelet (plt) count≥100×109/l 5) serum total bilirubin (tbil)≤1.5×uln 6) ast and/or alt≤2.5×uln 7) international normalized ratio（inr）≤1.5 and activated partial thromboplastin time (aptt) is normal 8) serum creatinine (scr)≤1.5 × uln 8. no previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. no history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of dfs were excluded; 9. subjects have voluntarily participated, signed and dated informed consent. exclusion criteria: 1. double primary lung cancer or multiple primary lung cancer; 2. subjects with mental illness; 3. presence or concomitant hemorrhagic diseases; 4. pregnancy or lactation; 5. known or suspected to be allergic to furmonertinib and / or other components of their preparations.

Keywords: nsclc egfr mutation adjuvant therapy
impact on ovarian reserve according to the type of ovarian endometrioma excision: laser versus conventional cystectomy

Conditions: Endometriosis Ovary

Summary: endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. it affects from 10 to 20% of women at reproductive age. different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate \> 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (oma). oma sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. the main objective of the present study is to compare laser versus conventional oma excision according to ovarian reserve in a pairwise-data study.


Eligibility criteria:
inclusion criteria: * age between 18 and 45. * bilateral endometriomas. * endometrioma size \> 3 cm. * pain and/or infertility as indication to surgical treatment. exclusion criteria: * history of cancer. * suspected malignancy. * evidence of premature ovarian failure.
eus - guided choledocho-duodenostomy versus ercp with covered metallic stents in patients with unresectable malignant distal common bile duct strictures

Conditions: Malignant Biliary Obstruction

Summary: eus - guided choledocho-duodenostomy (ecds) is an established option for bile duct drainage in unresectable malignant distal cbd strictures when endoscopic retrograde cholangiopancreatography (ercp) fails. however, how primary ecds compares with ercp with covered self-expanding metallic stents (csems) in unresectable malignant distal cbd strictures is uncertain. the aim of the current study is to compare primary ecds versus ercp with csems in unresectable malignant distal cbd strictures. we hypothesis that ecds is associated with a higher 1-year stent patency rate.

malignant biliary obstruction is a common sequela of pancreatic cancers or distal bile duct cancers, and its development can hinder the use of chemotherapy, decrease patient quality of life and decrease survival. malignant biliary obstruction is traditionally palliated with ercp with metallic stent insertion. however, these stents are prone to obstruction due to tumour ingrowth. in addition, ercp may not always be possible due to tumour obstruction and percutaneous biliary drainage may be required. recently, ecds has been described as an alternative to percutaneous biliary drainage in patients with failed ercp. the procedure is also associated with potential advantages as compared to conventional ercp. in particular, the risk of tumour ingrowth into the stent placed after ecds is low and stent patency rates may be better than ercp. thus, the aim of the current study is to compare primary ecds versus ercp with csems in unresectable malignant distal cbd strictures.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old with informed consent * histologically (preferred) or radiologically confirmed distal malignant bile duct tumors * inoperability by staging, comorbidities or patient wishes * distal tumors 2cm away from the portal hilum * bilirubin \> 50umol/l at diagnosis exclusion criteria: * multiple hepatic metastases with significant blockage of one or more liver segments (if no segment blockage, metastasis is not an exclusion criteria) * presence of main portal vein thrombosis * prior sems placement * intraductal papillary mucinous carcinomas * prior billroth ii or roux-en y reconstruction * history of bleeding disorder or use of anticoagulation * child's b/c cirrhosis * pregnancy * performance status ecog ≥3 (confined to bed / chair \> 50% waking hours) * presence of other malignancy * life expectancy \< 3months

Keywords: malignant biliary obstruction eus - guided choledocho-duodenostomy ercp with covered metallic stents
functional testing underlying coronary revascularisation

Conditions: Multivessel Coronary Artery Disease; Vessel Disease; Stable Angina; Unstable Angina or Stabilized Non-ST Elevated Myocardial Infarction; Patients With ST-elevated Myocardial Infarction; Revascularization of Culprit Coronary Artery

Summary: the objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (ffr) in multivessel coronary artery disease patients. the trial is a prospective, multicenter, french, randomized clinical trial including men and women ≥ 18 years presenting with significant multivessel disease defined by coronary angiography as coronary narrowing \> 50% diameter stenosis in at least 2 major epicardic vessels. the patients who give their informed consent will be randomly assigned to a therapeutic strategy based upon coronary angiography or angiography with ffr testing. in the ffr group, a significant coronary stenosis will be defined by a ffr ≤ 0.8. based upon this multivessel evaluation (angiography or ffr), the investigator will choose the best therapeutic strategy to his discretion (medical optimal treatment, coronary stenting, coronary artery bypass graft surgery). the aim of revascularization procedures will be to obtain complete revascularization. in the ffr group, only stenosis with ffr≤0.8 will be treated. the primary end point of the trial is a composite of major cardiovascular events including death from any cause, myocardial infarction, any hospitalization for coronary revascularization performed in addition to initial treatment and stroke at 1 year of follow-up. secondary end points will include adverse events, individual major cardiovascular events, stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.


Eligibility criteria:
inclusion criteria: * age \> 18 * referred to the cardiologist for one of the following medical condition : * st segment elevation myocardial infarction evolving for more than 7 days after revascularization of culprit coronary artery or * no st elevation acute coronary syndrome with or without troponin (t or i) elevation and medically stabilized for at least 12 hours or * stable angina (ccs i, ii or iii) or * chest pain diagnosis with suspicion of cad or with ischemia certificated by non invasive tests. * patients with at least 2 vessel disease (≥50% stenosis on angiography) including the left anterior descending coronary artery or with single vessel disease on left main coronary artery * patient willing and able to provide informed, written consent * patient not under legal protection * patient benefiting from the french health insurance exclusion criteria: * pregnancy, childbearing, absence of effective contraception * previous coronary bypass surgery * planned associated valvular surgery * life expectancy \< 2 years

Keywords: fractional flow reserve multivessel coronary artery disease angiography
strabismus surgery and driving ability

Conditions: Strabismus; Esotropia; Exotropia

Summary: the strabismus impacts binocular visual acuity and stereoscopy. thus, driving capacities of patients with strabismus may be reduced. the goal of this work is to study the possible amelioration of driving ability after strabismus surgery and to compare the driving capacities of patients with strabismus to a normal population; patients will be tested before and after strabismus surgery using a driving simulator, binocular visual field and binocular visual acuity.


Eligibility criteria:
inclusion criteria: * strabismus * age \> 18 yrs old * driving license exclusion criteria: * inability to driving under french law

Keywords: driving
acp for local application in ankle arthrodesis

Conditions: Ankle Arthritis

Summary: to compare the outcomes of patients who undergo three different types of surgeries for ankle fusion and reconstruction.

it is understood that an elevated concentration of platelets in the mix of the arthrodesis construct applied intra-operatively to the bony surface, has osteo-generating and enhanced wound healing properties. with that knowledge there is a clinical need and enthusiasm for the application of concentrated platelets, which release a large quantity of growth factors to encourage recovery in non healing injuries or surgical sites. this study represents an effort to more clearly define the true clinical outcomes with or without biologic enhancement, and fulfills a need for fortifying evidence concerning the efficacy of acp in live human bone healing-- based on radiographic and ct scans.

Eligibility criteria:
inclusion criteria: * patients whom present the need for the elective surgery exclusion criteria: * none
evaluation of neurocognitive changes in parkinson's disease after low frequency burst stimulation

Conditions: Parkinson Disease

Summary: this study aims to determine whether direct brain stimulation of specific regions and ranges improves cognition in people with parkinsons disease (pd) who already have a deep brain stimulator implanted. research activities consist of 32 subjects undergoing stimulation changes to their device and being administered neurocognitive tests to evaluate the changes. an fmri scan will also be done at baseline and at weeks 15 and 27. all subjects will undergo the stimulation changes in a randomized double blind crossover study. evaluation of stimulation changes will be assessed through analysis of neurocognitive data.

in this single-center pilot study, the investigators will study both acute and chronic changes to neurocognitive and motor performance in response to interleaving gamma/theta (theta burst) stimulation compared to standard-of-care gamma stimulation. this study will be a randomized double-blinded crossover study. each patient's baseline voltage intensity will be unchanged. during the first outpatient visit, a baseline assessment (under baseline stimulation parameters, including frequency, pulse width and voltage) consisting of motor and cognitive tests will first be performed. after one week of titration on the theta burst stimulation paradigm, all patients will randomized to either baseline or theta burst stimulation settings for one week. motor testing (updrs) and neuropsychological testing will be performed after this week. each patient will then be programmed to the other stimulation paradigm for another week. at the end of this third week, neuropsychological and motor testing will again be performed. patients will again be randomized into either baseline gamma stimulation or theta burst stimulation for the chronic phase of the study. repeat neuropsychological and motor testing will be performed at three months. each patient will switched to the other stimulation strategy and repeat neuropsychological and motor testing will be performed after another three months. after the first 6 months, patients will be placed on open-label theta burst stimulation for 6 months (total of one year). at the end of one year, patients will undergo repeat neuropsychological and motor testing, after which they will be reprogrammed to their initial settings or given the option to remain on theta burst stimulation parameters. functional magnetic resonance imaging will be acquired during baseline, week 15, and week 27 visits for patients with compatible devices that meet the inclusion criteria.

Eligibility criteria:
inclusion criteria: 1. male or female patients who had previously undergone bilateral stn deep brain stimulation implantation 2. age \>18 years old 3. stable medication regimen for at least 3 months. 4. patient informed and able to give written consent 5. able to comply with all testing, follow-ups and study appointments and protocols exclusion criteria: 1. history of epilepsy or seizure 2. history of dementia 3. history of major substance abuse

Keywords: deep brain stimulation
clinical efficacy of conventional and diode laser-assisted frenectomy in patients with abnormal different frenum insertions: a retrospective study

Conditions: Frenulum; Elongation

Summary: aim: the aim of this retrospective study was to assess the frenum attachment recurrence and evaluate clinical parameters after conventional and diode laser-assisted frenectomy in patients with different abnormal frenum insertions. methods: data records of 429 patients treated with maxillary labial frenectomy between january 1, 2016 and january 1, 2018 were screened. records of 70 patients meeting the inclusion criteria were evaluated. data were analyzed in terms of gender, age, category of frenum, presence of diastema, operation technique, type of periodontal disease. the distance between frenum attachment and mucogingival junction (fmgj), plaque index (pi), gingival index (gi) and probing depth were assessed.


Eligibility criteria:
inclusion criteria: (a) systemically healthy, (b) nonsmoker, (c) aged between 18 and 65 years, (d) received initial periodontal treatment before frenectomy, (e) presence of central and lateral incisors and canines at maxilla, (f) not received any kind of periodontal surgery, prosthodontic and restorative treatment which may affect the anatomy of the relevant region. exclusion criteria: subjects with incomplete documentation and without at least 6-week follow-up observation were excluded.

Keywords: labial frenum laser therapy recurrence oral hyigiene