Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of upadacitinib in participants with takayasu arteritis (tak)

Conditions: Takayasu Arteritis (TAK)

Summary: the main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.


Eligibility criteria:
inclusion criteria: * participants must be at least 18 years of age (at least 15 years of age in japan) * clinical diagnosis of tak and fulfilling the japanese guidelines for management of vasculitis syndrome 2017 criteria. * participant must have experienced a relapse of tak within 12 weeks of baseline despite being on treatment with oral corticosteroid. * participants must be in remission and on a stable corticosteroid dose prior to baseline. exclusion criteria: * treatment with an interleukin-6 (il-6) inhibitor or janus kinase (jak) inhibitor (including but not limited to tocilizumab, sirukumab, sarilumab, upadacitinib, tofacitinib, baricitinib, ruxolitinib, peficitinib, and filgotinib) within 4 weeks of baseline. * current use of immunomodulators other than corticosteroids.

Keywords: takayasu arteritis (tak) upadacitinib placebo corticosteroid prednisolone
efficacy and safety study of indacaterol maleate/glycopyrronium bromide in chronic obstructive pulmonary disease (copd) patients.

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to demonstrate that the efficacy of the combination product qva149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of fev1 auc0-24h while maintaining an acceptable safety profile.


Eligibility criteria:
inclusion criteria: * male or female adults aged ≥40 yrs * smoking history of at least 10 pack years * diagnosis of stable chronic obstructive pulmonary disease (copd) as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2015) * post-bronchodilator forced expiratory volume in 1 second (fev1)\< 80% and ≥ 30% of the predicted normal value and post-bronchodilator fev1/fvc (forced vital capacity) \<70% * modified medical research council questionnaire grade of 2 or higher exclusion criteria: * patients who have had a respiratory tract infection within 4 weeks prior to visit 1 * patients with concomitant pulmonary disease * patients with a history of asthma * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular co-morbid conditions * patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * patients in the active phase of a supervised pulmonary rehabilitation program * patients contraindicated for inhaled anticholinergic agents and β2 agonists * other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic obstructive pulmonary disease (copd)
an fnirs study of motor cortical activation in stoke patients

Conditions: Acute Ischemic Stroke

Summary: the investigators evaluate the activation and connectivity of patients' motor regions in the acute phase of ischemic stroke by fnirs.

this study aims to analyze the progress of brain recovery from upper-limb deficit due to acute ischemic stroke, using functional near-infrared spectroscopy(fnirs) as the main neural imaging method. fifty patients having experienced a stroke onset within seven days will be recruited from the emergency room. the fnirs signals will be recorded bilaterally over the contralateral sensorimotor cortex, the premotor area, the supplementary motor area, the primary motor cortex for 14 days after being diagnosed. then compute activation and connectivity of the regions. the motor function data measured by the assessment scales, as well as the behavioral record during the fnirs motor tasks will be collected as well.

Eligibility criteria:
inclusion criteria: * the diagnosis of ischemic stroke should meet the diagnostic criteria of the "china guidelines for the diagnosis and treatment of acute ischemic stroke 2018". * 18 years old≤ age ≤ 75 years old. * cerebral ischemic stroke onset within 7 days. * first onset. * upper limb motor dysfunction. exclusion criteria: * unstable vital signs. * complicated with other diseases in the nervous system. * combined with other serious disease states: circulatory system, respiratory system, * motor system diseases, such as atrial fibrillation, heart failure, lung infection, severe liver and kidney dysfunction, lower limb venous thrombosis, etc. * upper limb dysfunction caused by other reasons, such as fractures, upper limb deformities, etc. * contraindicated to imaging tests, such as metal implantation, claustrophobia, and severe obesity. * those who cannot complete the examination due to other reasons, such as mental disorders, cognitive dysfunction, etc. * other causes: alcoholism; pregnancy; skull defects; soft tissue injuries at the site of examination; visual impairment, etc.

Keywords: stroke motor rehabilitation brain regions fnirs
biomarkers in prostate cancer treated with srp following failure of fat

Conditions: Prostatic Neoplasms

Summary: the ability of genomic biomarkers to measuring tumour aggressiveness, and facilitate the selection of therapies in patients who had salvage radical prostatectomy after focal therapy and predict the risk of biochemical recurrence bcr after focal therapy or rp.

between 2007 and 2017, 30 patients underwent salvage radical prostatectomy srp for recurrent localized pca at our institution (institute mutual montsouris). primary radiotherapy, brachytherapy and whole-gland treatments were excluded, as to evaluate the true spectrum of morphologic changes caused by the focal emerging ablative modalities. thirteen srp after focal ablative therapies fat (cryotherapy or high intensity focused ultrasound- hifu or vascular-targeted photodynamic therapy- vtp) were identified from our prospective collected database. genitourinary pathologists were provided clinical information related to prior therapies and immunohistochemical (ihc) markers were used in the diagnosis of limited primary pc on needle biopsy when necessary. prostatectomy specimens were processed and the number of tumor foci, size of the dominant focus and pathological stage were recorded. residual disease was graded according to the gleason grading system. treatment-related histologic changes were examined.

Eligibility criteria:
inclusion criteria: * prostate cancer treated with salvage radical prostatectomy following failure of focal ablative therapies exclusion criteria: * primary radiotherapy, brachytherapy and whole-gland treatments
effect of nightly versus prn sildenafil on early return of erectile function following laparoscopic radical prostatectomy

Conditions: Prostate Cancer

Summary: the ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one nvb was spared. this study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. the investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.


Eligibility criteria:
inclusion criteria: 1. male sex 2. age \< 65 3. iief erectile function domain score \> 26 (out of 30 points possible for this subscale) 4. steady sexual partner 5. untreated prostate cancer tnm stage \< ct2bnxmx (ct1a, ct1b, ct1c, ct2a) and gleason grade \< 8. 6. willingness to participate in a clinical trial as manifested by informed consent 7. actually undergo nerve-sparing lrp surgery exclusion criteria: 1. not fulfilling all of the criteria for entry above 2. any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy) 3. contraindication to sildenafil (e.g. nitrates, hypersensitivity) 4. existing pde5 inhibitor requirement for functional erection (e.g. for intercourse) preoperatively 5. obstructive sleep apnea

Keywords: laparoscopic radical prostatectomy nightly sildenafil
hemopatch implication after axillary dissection for breast cancer

Conditions: Breast Cancer

Summary: aim of this randomized study is to assess the value of a different haemostatic sealant, the hemopatch®, in axillary lymph node dissection (alnd) to reduce the incidence of seroma and seroma-related complications.

with the de-escalation of axillary lymph node dissection (alnd) to sentinel lymph node biopsy as a surgical procedure staging in breast cancer (bc), the physical and psychological morbidity has been improved significantly. however, alnd is still considered in a relevant number of bc patients as treatment for controlling locoregional axillary disease, and these patients present still important complications related to alnd, such as neuropathy, limitation of shoulder movement, arm lymphedema, and most commonly seroma evolution. multiple surgical devices with the intent to improve sealing of lymphatic and blood vessels have demonstrated contrasting results in the incidence of seroma formation after alnd and are no utilized routinary. non-surgical devices, such as chemical medications, sealing small vessels by stimulating collagen and fibrinogen syntheses, also could improve to sealing of the lymphatic vessels. additionally, fibrin glue-coated collagen patches and fibrin glue application to the surgical cavity were already tested in alnd patients with contrasting benefit in term of seroma prevention. unfortunately, none of these studies provided a good solution to eliminate or reduce the incidence of seroma after alnd in bc treatment. aim of this randomized study is to assess the value of a different haemostatic sealant, the hemopatch®, in axillary lymph node dissection (alnd) to reduce the incidence of seroma and seroma-related complications.

Eligibility criteria:
inclusion criteria: * patients with primary breast cancer * mastectomy or breast conserving surgery * patients eligible for axillary dissection * male or female * any age * previous (or not) neoadjuvant treatments * any breast histotypes exclusion criteria: * previous axillary surgery

Keywords: primary breast cancer axillary dissection axillary seroma
autologous versus synthetic versus biological sling for trans-obturator correction of urinary stress incontinence

Conditions: Stress Urinary Incontinence

Summary: the treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (tot), is a largely used sling-adopting procedures. the efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (tvt). to date the results of tot in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. at this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for tot in women with urinary stress incontinence.

women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). all patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit . all eligible patients will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. during the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient. data will be analyzed using the intention-to-treat principle and a p value of 0.05 or less will be considered significant.

Eligibility criteria:
inclusion criteria: * genuine stress urinary incontinence by self report, examination and test * urethral hypermobility * eligible for all three surgical procedures * ambulatory exclusion criteria: * pregnancy * \<12 months post-partum * systemic disease and/or drugs known to affect bladder function * current chemotherapy or radiation therapy * urethral diverticulum, augmentation cytoplasty, or artificial sphincter * recent pelvic surgery * severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree * previous pelvic or anti-incontinence surgery * history of severe abdominopelvic infections * known extensive abdominopelvic adhesions * detrusor instability and/or intrinsic sphincter dysfunction * other gynaecologic pathologies (eg, fibroids, ovarian cysts) * bmi \>30

Keywords: autologous biological mesh polypropylene sling synthetic stress incontinence surgery tot treatment
early transjugular intrahepatic portosystemic shunt for advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma; Variceal Bleeding

Summary: hepatocellular carcinoma (hcc) with main trunk portal vein tumor thrombus (pvtt) has poor prognosis. the main lethiferous factor is the upper gastrointestinal hemorrhage by pvtt-related portal hypertension. studies have proven that early transjugular intrahepatic portosystemic shunt (tips) with 72 hours after acute variceal bleeding is effective.

portal hypertension by main trunk portal vein tumor thrombus (pvtt) is a severe disease. patients usually die of gastrointestinal hemorrhage rather than tumor progression. it is vital to prevent the portal hypertension. transjugular intrahepatic portosystemic shunt (tips) is an effective method to alleviate the portal pressure. then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. studies have proven that early transjugular intrahepatic portosystemic shunt (tips) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. however, the pvtt induced portal hypertension still needs clinical evidence. in this study, the investigators explore the early tips for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. the investigators aim to added clinical evidence for this subtype of advanced hcc.

Eligibility criteria:
inclusion criteria: 1. diagnosis of primary hcc, confirmed histologically or clinically according to the criteria of the american association for the study of liver diseases; 2. presence of pvtt with iii-iv grade by cheng's criteria; 3. having pvtt induced portal hypertension; 4. tips was performed within 72 hours after the endoscopic hemostasis; 5. metastases with limited five sites and no more two organs involved; 6. number of intrahepatic tumors were no more than five; 7. receipt of lenvatinib and pd-1 inhibitor as the first-line systemic therapy; 8. classified as child-pugh class a or b and having an eastern cooperative oncology group (ecog) performance status of 0 or 2; 9. no history of other malignancies; 10. agreed to participated in this clinical trial; 11. hemameba ≥3.0 x109/l, neutrophil ≥1.5x109/l, hemoglobin≥10.0 g/l, platelet≥100x 109/l, alt; ast; bilirubin ≤1.5-fold normal, gfr≥60ml/min. exclusion criteria: 1. recurrent hcc; 2. pvtt at i-ii grade by cheng's criteria; 3. age \ 75 years; 4. advanced hcc with more than five metastases; 5. number of intrahepatic tumors were more than five; 6. no response to lenvatinib; 7. life expectancy less than 3 months.

Keywords: advanced hepatocellular carcinoma variceal bleeding therapeutic endoscopy transjugular intrahepatic portosystemic shunt
modelling interface pressure applied by superimposed compression bandages

Conditions: Risk of Venous Thrombosis

Summary: the aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of biflex 16 (thuasne) and/or rosidal k (lohmann \& rauscher). the patient specific model should better predict the interface pressure distribution than laplace's law.

the measurement of the patients' legs shapes will be performed thanks to an optical scanner. the patients' posterior part of the calf will be submitted to a localized compression test, in order to characterize the soft tissue mechanical properties of both legs. pressure measurements, applied by the different bandages, will be taken at the height of measurement points b1 and c on the lateral and medial sides of the leg in supine, sitting and standing positions, on both legs. 2 single bandages (biflex 16 (thuasne) and rosidal k (lohmann \& rauscher)) and their different combinations will be applied on the patient's legs. the order of bandage application for each patient is randomized, but is the same for both legs. the order of the leg (right or left) on which the bandages are applied is randomized.

Eligibility criteria:
inclusion criteria: * male or female between 18 and 80 years old * at risk of venous thrombosis, who need to wear compression (socks, stockings or bandage) * hospitalized in the service of physical medicine and rehabilitation, in saint-etienne, france * bmi between 20 and 35 * able to stand for at least 10 minutes in a standing frame * signed informed consent to take part in the study * covered by a health insurance system * not taking part in another study which interfere with the results of the present study exclusion criteria: * compression bandages contraindications * allergy to one of the different bandages components * history of deep or superficial vein thrombosis * venous or arterial ulcer * cutaneous wound on the lower leg * cognitive, behavior or physical disorder preventing the communication and the active participation to a rehabilitation program, or a clinical study * patient under any legal protection (except curatorship) * not covered by a health insurance system

Keywords: compression bandages
zanubrutinib in patients with igg4-related disease

Conditions: IgG4 Related Disease

Summary: the aim of this clinical trial is to evaluate the safety and efficacy of zanubrutinib in treating patients with igg4-related disease

this will be a single-site, open-label study in symptomatic patients with igg4-related disease affecting the submandibular and/or lacrimal glands. all patients will receive zanubrutinib orally at a dose of 80mg bid for 24 weeks. the primary objective of this study is to demonstrate that zanubrutinib treatment reduces reduces the volume of the submandibular and/or lacrimal glands on pet/mri at week 24 compared to baseline.

Eligibility criteria:
inclusion criteria: * men or women aged 18 to 85, inclusive, at the time of initial screening * have histopathologically confirmed igg4-rd in the submandibular gland and/or the lacrimal gland confirmed by international consensus pathology criteria * presence of a lymphoplasmacytic infiltrate with 10 igg4+ plasma cells per high-power field and/or an igg4+/igg+ plasma cell ratio of 40% * all women must test negative for pregnancy and agree to use a reliable method of birth control * no current treatment with immunosuppressive medications other than prednisone 40mg daily (or other glucocorticoid equivalent) with stable dosing for 28 days exclusion criteria: * unstable prescribed dose of glucocorticoids within 28 days prior to baseline * any treatment with a synthetic dmard including but not limited to hydroxychloroquine, methotrexate, leflunomide, or sulfasalazine within 28 days prior to baseline * any treatment with a cytotoxic or immunosuppressive drug including but not limited to cyclophosphamide, mycophenolic acid, azathioprine, cyclosporine, sirolimus, or tacrolimus within 28 days prior to baseline * any treatment with a btk inhibitor within 6 months before baseline * any treatment with a jak inhibitor within 28 days prior to baseline * use of biologic agents including infliximab, abatacept, or tocilizumab within 56 days prior to baseline * use of a b cell depleting therapy (such as rituximab) within 12 months prior to baseline * a history of, or current, inflammatory or autoimmune disease (that could affect the interpretation of safety or efficacy outcomes) other than igg4-related disease * evidence of active tuberculosis, hiv, or hepatitis b or c infection * history of cancer other than non-melanoma skin cancer, cervical dysplasia or carcinoma in situ (cured \>1 year), prostate cancer (cured \>5 years), or colon cancer (cured \>5 years)
comparison of medical results of testicular sperm extraction by conventional surgery and microsurgical track

Conditions: Azoospermia

Summary: to compare mobile sperm extraction rate between microtese and conventional tese in 18-50 years-old men with non obstructive azoospermia.

about one in ten couples cannot have children without medical assistance. male factors for infertility are identified in half cases with 10% azoospermia, non-obstructive in most cases. up to date, testis surgical sperm retrieval for use in icsi-ivf is the only possibility for those men to have children with their own sperm. several options are available for surgically retrieving sperm from testis: during conventional testicular sperm extraction (ctese), the testis is exposed through a small incision, then 1 or more biopsies are randomly made. up to date, ctese is considered as the gold-standard for sperm extraction in this population. however, the success of surgical sperm extraction concerns a man out of two having ctese for non-obstructive azoospermia. on the other hand, schlegel showed in 1997 that ctese induces a significative loss of testicular tissue with possible impact on male endocrine balance with occurence of hematomas, inflammatory reshuffles and ischaemic lesions, compromising some regions in the testicular parenchyme. another option for surgical sperm extraction is micro-surgery called microtese (or µtese). it consists in examining the testicular parenchyme under a high-power microscope (up to 25 magnification), screening for white opaque tubules with higher diameter which indicates possible active spermatogenesis. the benefits of µtese are: (1) a better identification of sites of sperm production in the testis, (2) a better preservation of testicular vasculature decreasing the risk of postoperative hematoma or tissue ischemia and (3) excision of 3 to 10 times less tissue. nevertheless, no randomized studies have compared both techniques to validate such an assumption. in 2014, the results of a meta-analysis performed by deruyver showed that, among the 7 original articles comparing ctese to µtese, 3 were retrospective studies and the remaining 4 prospective studies were not randomized. it is highly unlikely that this better outcome is related to patient selection. nevertheless, the relatively small number of studies comparing both methods makes it difficult to draw definitive conclusions this study is based on the hypothesis that µtese is a superior technique than ctese with a difference of 20% like observed in deruyver's meta-analysis. the principal objective is to compare motile sperm extraction rate between μtese and ctese in 18-50 years-old men with noa.

Eligibility criteria:
inclusion criteria: * 2 consecutive spermograms (with ±3 months interval) confirming absence of sperm (azoospermia) * diagnosis of non-obstructive azoospermia on the basis of a complete history, physical examination, endocrine profile, ultrasound and chromosomal analysis exclusion criteria: * history of previous testicular surgery, except orchiopexy for undescended testis. * monochordy * ultrasound revealed testicular nodule * y chromosome microdeletions type azfa and b.